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Potential food allergens in medications
Abstract
Excipients are substances in pharmaceuticals other than the active ingredients. Some excipients are foods or substances derived from foods, raising the possibility that these substances would pose a hazard to patients with food allergy. This review describes which food-derived substances are used as pharmaceutical excipients in which medications and reviews published data regarding the safety of the administration of these medications to recipients with food allergy. Such reactions are rare, usually because the amount of food protein is not present in a large enough quantity to elicit a reaction. When a food protein appears as an unintentional contaminant, the amount, if any, that is present might be variable and might elicit reactions only from some lots of medication or only in some patients. In most circumstances these medications should not be routinely withheld from patients who have particular food allergies because most will tolerate the medications uneventfully. However, if a particular patient has had an apparent allergic reaction to the medication, potential allergy to the food component should be investigated.
... Hidden food allergens in medications can lead to unpredictable allergic reactions. Food-derived substances are used to protect, support, or enhance stability or for bioavailability or for patient acceptability during the manufacturing process of medications [4]. The aim of this review is to provide existing data about egg, red meat, gelatin, and fish allergens in medications. ...
... Gelatin is added to vaccines as a preservative and stabilizer to protect the vaccine from adverse conditions such as freeze-drying or heat during storage and to maintain the vaccine as safe and effective. The amount of gelatin varies between 15 μg and more than 15,500 μg/dose of vaccine [4,27]. The highest amounts are found in the measles-mumps-rubella (MMR), rabies, varicella-zoster, oral typhoid fever, and yellow fever vaccines, and lesser amounts (up to 2000 μg/dose) in diphtheriatetanus-pertussis (DTP) and influenza vaccines. ...
... Fish oils are generally highly purified and should not contain fish protein. Fish-allergic patients can consume fish oils uneventfully [4,54]. ...
Childhood food allergies are a growing public health problem. Once the offending food allergens have been identified, a strict elimination diet is necessary in treatment or prevention of most of the allergic reactions. Accidental food ingestion can lead to severe anaphylaxis. Food- derived substances can be used in medications at various stages of the manufacturing process. In this review, the possible roles of medications which may contain egg, red meat, gelatin, and fish allergens on allergic reactions in children with food allergy were evaluated.
... Although established excipients have precedence of showing safety on the population level and can be reviewed to evaluate their toxicities, health effects that are undetectable in current preclinical toxicology screenings could remain obscured. Scattered case reports (5)(6)(7) have brought this to the attention of formulation scientists (4), clinicians (5), and legislative agencies (8,9), but the magnitude and scope of this challenge is currently unknown. ...
... Although established excipients have precedence of showing safety on the population level and can be reviewed to evaluate their toxicities, health effects that are undetectable in current preclinical toxicology screenings could remain obscured. Scattered case reports (5)(6)(7) have brought this to the attention of formulation scientists (4), clinicians (5), and legislative agencies (8,9), but the magnitude and scope of this challenge is currently unknown. ...
... Many allergic reactions to inactive ingredients are Type I hypersensitivity reactions, mediated by Immunoglobulin E recognition of an antigen and characterized by symptoms associated with histamine release such as urticaria, angioedema, bronchospasm, and anaphylaxis (10). Such rare effects can lead to drastic adverse events in small patient subpopulations (5,11). Conversely, intolerances to an inactive ingredient can cause symptoms through mechanisms such as malabsorption, which causes gastrointestinal symptoms via direct osmotic effects or as a result of their fermentation in the digestive system. ...
Oral forms of medications contain "inactive" ingredients to enhance their physical properties. Using data analytics, we characterized the abundance and complexity of inactive ingredients in approved medications. A majority of medications contain ingredients that could cause adverse reactions, underscoring the need to maximize the tolerability and safety of medications and their inactive ingredients. Copyright © 2019 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.
... When milk allergen appears as an unintentional contaminant, the amount is variable and might elicit reactions only from some lots of medication or only in some exquisitely allergic patient. 30 Thus, no special precautions are required when administering vaccines to milkallergic patients. 30,31 If a milk allergic patient suffer an allergic reaction to one of these vaccines, the possibility of milk protein contaminating the vaccine should be considered. ...
... 30 Thus, no special precautions are required when administering vaccines to milkallergic patients. 30,31 If a milk allergic patient suffer an allergic reaction to one of these vaccines, the possibility of milk protein contaminating the vaccine should be considered. 32 There were no anaphylaxis events triggered by insect bites in the present study, consistent with published data in the Chinese population. ...
Background:
Little is known about anaphylaxis in Chinese children. This study aimed to determine the age-specific patterns of anaphylaxis in Chinese children.
Methods:
We conducted a retrospective study of anaphylaxis cases attending an allergy department in a tertiary children's hospital.
Results:
A total of 279 anaphylactic reactions in 177 patients were analyzed. Overall, 57.6% (102/177) of first anaphylaxis events occurred in infants (0-2 ys). Foods were the most common culprits (88.5%), followed by food + exercise/exercise (4.7%), and drugs (4.3%). The main food allergens were cow's milk (32.9%), egg (21.4%), and wheat (20.7%) in infants, compared with fruits/vegetables at 35.9% in preschool-age children (3-6 ys) and 31.6% in school-age children (7-12 ys). The most commonly implicated drug triggers were vaccines (n = 5, comprising DTaP n = 2, group A + C meningococcal polysaccharide vaccine n = 1, Sabin vaccine n = 1, and not specified n = 1). Among the 5 vaccine-induced anaphylaxis patients, 4 had severe cow's milk allergy. The clinical manifestations were mainly mucocutaneous (86.0%), followed by respiratory (68.8%), gastrointestinal (23.7%), neurological (10.4%), and cardiovascular (0.7%). Compared with patients of other ages, infants had higher rates of hives (0-2ys 77.4%, 3-6ys 50%,7-12ys 57.9%, 13-17ys 38.9%, p = 0.016) and vomiting (0-2ys 20.7%, 3-6ys 1.6%,7-12ys 8.8%, p < 0.001), while wheezing was more frequent in school-age children (0-2ys 21.4%, 3-6ys 25%, 7-12ys 38.6%, 13-17ys 5.6%, p = 0.017) and abdominal pain was more common in adolescents (0-2ys 2.1%,3-6ys 15.6%, 7-12ys 14.0%, 13-17ys 72.3%, p < 0.001). Regarding treatment, 9.3% of anaphylaxis events and 24.1% of life-threatening reactions were treated with epinephrine.
Conclusions:
We observed age-related clinical patterns of anaphylaxis in this study, with hives and vomiting most commonly reported in infants and cardiovascular symptoms rarely reported in children. Wheat was the third most culprit food allergen after egg and milk in infancy. Education regarding more aggressive use of epinephrine in the emergency setting is clearly needed. Recognition of age-related symptoms in anaphylaxis can aid physicians in prompt diagnosis and acute management.
... Taken together, these results suggest that the low initial prescription rates of generics in 56 See Kelso (2014) and Page and Etherton-Beer (2017) for reviews. Recent research does suggest more attention should be given to allergies and excipients as they are often not reported on prescription drug ingredient lists. ...
... The active ingredient of a multisource and generic drug are identical in terms of product quality, and several studies have documented no substantial differences between the quality of generics and brand name drugs when used in controlled environments (Kesselheim et al., 2008;Gagne et al., 2014). While it is possible that patients are allergic to excipients (the inactive ingredients), such allergies are typically rare and highly idiosyncratic between patients and can therefore not account for large average quality differences (Kelso, 2014;Page and Etherton-Beer, 2018). 73 Therefore, the difference between ξ B ip0 and ξ G ip0 represent a physician's bias towards brand-name drugs. ...
This dissertation examines the importance of incentive schemes or personnel policies in three distinct labor markets. The first essay answers the following question: How important are patient and physician-specific factors in explaining persistent prescription behavior? A wide range of research has suggested that prescription behavior is highly persistent and an important barrier to realizing cost savings, but the sources of this persistence are not well understood. I quantify the importance of physician and patient factors in physician prescription behavior by exploiting a policy mandate in Belgium requiring physicians to prescribe a minimum percentage of cheap drugs, using detailed administrative data on 24 million prescription drugs dispensed to 152,000 patients. First, I show that physicians increase the prescription rate of generics for first-time users of an active ingredient by 10 percentage points. They do so without compromising on quality of dispensed drugs. Second, I find that first-time patients are more likely to receive a generic than long-time patient are likely to be switched from a branded to a generic drug, suggesting physicians consider the latter costly to switch. I find that switching a patient indeed comes at a cost, measured in decreased medication adherence. Building on this reduced form evidence, I develop and estimate a structural model. I use the model estimates to simulate the entry of generics and find physician and patient factors are about equally important in explaining the slow adoption of generics. Requiring pharmacists to only dispense generics decreases welfare, unless patient considerations are decreased by at least 60%. In a second essay, I estimate the effect of domestic outsourcing events on wages of workers remaining in outsourcing establishments. I use employer-employee linked data from Germany that includes detailed administrative information on earnings, industry and occupation of employment. I exploit outsourcing event as my main source of identification and find substantial effects on the wages of workers that stay: holding worker ability constant, high skilled workers receive, on average, an immediate wage increase of about five log points, while low skilled worker face a wage cut of about one log points. On average, wage increases enjoyed by high skilled workers are positively correlated with changes in the skill ratio within the establishment. I propose a new theoretical model of wage setting in which fairness considerations generate spillover effects that are consistent with these two empirical findings. Taken together, these results indicate fairness considerations may play a role in wage setting. In a third essay, co-authored with Kevin Stange and Brian Jacob, we investigate the role of instructors in promoting student success. We explore this issue in the context of the University of Phoenix, a large for-profit university that offers both online and in-person courses in a wide array of fields and degree programs. We focus on instructors in the college algebra course that is required for all BA degree program students. We find substantial variation in student performance across instructors both in the current class and subsequent classes. Variation is larger for in-person classes, but is still substantial for online courses. Effectiveness grows modestly with course-specific teaching experience, but is unrelated to pay. Our results suggest that personnel policies for recruiting, developing, motivating, and retaining effective postsecondary instructors may be a key, yet underdeveloped, tool for improving institutional productivity.
... Nevertheless, we found a few reports about allergic reactions to histamine antagonists [1][2][3][4] for the last several years. We also came across several publications stating that potential allergic reactions did not relate to the active substance of the drug, but its excipients such as lactose, gelatin, chemical dyes, food colorings, gluten, soy, peanuts oil, etc. [5][6][7] Despite the frequent use of cornstarch as an excipient in oral medications, we did not find any report about allergic reactions caused by it during peroral treatment, and only a few publications that we found on cornstarch contained in medical gloves 8,9 referred to it as a causative factor of some allergy-like conditions. As a whole, hypersensitivity to corn/maize is not a common type of allergy as well. ...
... And finally, we come back to the question of the causative value of desloratadin/aerius. In the literature available we found several publications stating the occurrence of allergic reactions to inactive ingredients of medications, and the most common causes of such reactions were gelatin, food coloring, additives, soy, gluten, etc. [5][6][7] However, there were only scarce mentions of cornstarch and without any reference to any case report. In our case, since the composition of desloratadine/aerius includes cornstarch, as reported by the manufacturer (Schering-Plough Labo N.V., Belgium),the drug challenge-"gold standard" in the diagnosis of drug hypersensitivity, 13 was performed with an aim to exclude the causative significance of the active ingredient desloratadine and confirm the impact of cornstarch. ...
Sometimes allergic reactions caused by various food allergens often hidden in the composition of medications can mistakenly be diagnosed as drug allergies. Such reactions can especially be unexpected if antihistamines-virtually designed to treat allergy symptoms, are imitated. We present the case of a 37-year-old female patient with cutaneous allergic reaction initially diagnosed as drug allergy to desloratadine/aerius, a desloratadine-containing antihistamine medication. The diagnostic search began with the anamnestic data of the patient about an allergy to cooked corn in her childhood, current seasonal allergic rhinitis, and hand dermatitis probably related to her professional activity. Skin tests and additional laboratory examinations led to diagnosing corn/maize allergy manifested as both food (mainly) and pollen allergy. Besides, it was concluded that hand dermatitis also can becaused by cornstarch contained in medical gloves. Finally, based on the results of a drug challenge test performed with two desloratadine-containing medications-desloratadine/aerius containing cornstarch as an excipient and desloratadine/lordestinenot containing cornstarch, the causative significance of corn was confirmed. Thus, the initial diagnosis of drug allergy was changed to that of food allergy.
... On the other side, an increase in allergic diseases has been observed worldwide (Kelso 2014;Ainsworth et al. 2010;Patja et al. 2001;James et al. 1995). Parents of children allergic to egg proteins are wary of allergic reactions after MMR vaccine administration. ...
... Contemporary studies conclusively demonstrate that the protein of egg whites in the MMR vaccine is but at a trace concentration or just unmeasurable. Thus, the vaccine may be safely and restriction free administered to patients with allergy to this protein (Kelso 2014). A British study, reviewing the 1996-2009 literature and the pediatricians and family doctors adherence to vaccination administration, has shown that 81% of children in whom vaccination is delayed for more than 30 days do not actually meet criteria for severe allergic reactions to egg proteins, which obviates the need to vaccinate them in the hospital setting (Ainsworth et al. 2010). ...
A worrying increase in the number of measles cases has been noted recently in Poland, which may have to do with a decreasing proportion of children vaccinated against measles, mumps, and rubella (MMR) in the second year of life (<95%). For many years, MMR vaccination in children has been associated with a fear of allergy to eggs. This study seeks to define the reason and justification for postponing MMR vaccination in a population of children referred to the outpatient specialist immunization clinic. One hundred and thirty eight (138) children, mean 24.5 ± 26.6 months, with a history of past allergies, in whom the first-time MMR vaccination was delayed by family doctors for fear of allergic reactions, were enrolled into the study. The mean delay in a vaccine shot was 12.3 ± 26.9 months. There were 101 children who displayed a distinct allergy to the egg proteins, among other accompanying types of allergy. All of the 138 children were found eligible to receive MMR vaccine at the visit to the clinic. No early allergic responses were noticed in any of the children. There were negligible delayed allergic responses in six children, all from the egg allergy group. We conclude that MMR vaccination in children with egg allergy is safe and can be conducted on the outpatient basis without any specific precautions or safety measures. Delays in vaccination were unjustified and may jeopardize children’s health. There is a need for insightful education of primary care doctors concerning of MMR vaccination safety, particularly when allergy is suspected, to avoid unduly and potentially harmful delays.
... Las PH se encuentran en la triple viral en escasa cantidad y pueden aplicarse de forma habitual ante APH. 93,94 Mayor concentración hay en vacunas de gripe y fiebre amarilla. 93 Se ha determinado la seguridad de la vacuna inactivada para influenza en APH, 94-96 mientras que la de la fiebre amarilla será testeada antes de aplicarla. ...
... 93,94 Mayor concentración hay en vacunas de gripe y fiebre amarilla. 93 Se ha determinado la seguridad de la vacuna inactivada para influenza en APH, 94-96 mientras que la de la fiebre amarilla será testeada antes de aplicarla. 92 Con respecto a la gelatina, los alérgicos a esta deben evitar productos que la contengan. ...
Food allergy arises from a specific immune response induced by food exposure. It is the first cause of anaphylaxis in childhood. Its prevalence increased exponentially in western countries. The proteins most frequently involved in infants are cow's milk and hen's egg; and in adults, seafood. Peanuts have the same frequency in both groups. The clinical manifestations and methodology of study are directly related to the pathophysiology of the disease. Clinical history, skin prick test, patch test, and food oral challenge are essential to arrive at a correct diagnosis, that will avoid unnecessary exclusions or exposures that carry life risk. The treatment is based on the correct avoidance of responsible food (considering hidden allergens), besides patient and their care giver's education, to maintain a good quality of life.
Sociedad Argentina de Pediatría.
... The overwhelming majority of milk-allergic children receive these vaccines uneventfully. If milk allergy is responsible for these reactions, it likely involves the very rare coincidence of an exquisitely allergic patient and a particular lot of vaccine contaminated with larger milk peptide fragments [162]. Thus, no special precautions are required when administering vaccines to milk-allergic patients [162,163]. ...
... If milk allergy is responsible for these reactions, it likely involves the very rare coincidence of an exquisitely allergic patient and a particular lot of vaccine contaminated with larger milk peptide fragments [162]. Thus, no special precautions are required when administering vaccines to milk-allergic patients [162,163]. However, should a milk allergic patient suffer an allergic reaction to one of these vaccines, the possibility of milk protein contaminating the vaccine should be considered. ...
Background
Routine immunization, one of the most effective public health interventions, has effectively reduced death and morbidity due to a variety of infectious diseases. However, allergic reactions to vaccines occur very rarely and can be life threatening. Given the large numbers of vaccines administered worldwide, there is a need for an international consensus regarding the evaluation and management of allergic reactions to vaccines. Methods
Following a review of the literature, and with the active participation of representatives from the World Allergy Organization (WAO), the European Academy of Allergy and Clinical Immunology (EAACI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI), the final committee was formed with the purpose of having members who represented a wide-range of countries, had previously worked on vaccine safety, and included both allergist/immunologists as well as vaccinologists. ResultsConsensus was reached on a variety of topics, including: definition of immediate allergic reactions, including anaphylaxis, approaches to distinguish association from causality, approaches to patients with a history of an allergic reaction to a previous vaccine, and approaches to patients with a history of an allergic reaction to components of vaccines. Conclusions
This document provides comprehensive and internationally accepted guidelines and access to on-line documents to help practitioners around the world identify allergic reactions following immunization. It also provides a framework for the evaluation and further management of patients who present either following an allergic reaction to a vaccine or with a history of allergy to a component of vaccines.
... Adverse reactions to lactose-containing DPIs in patients with CMPA are seemingly rare, and so some authors have stated that patients with CMPA "need not avoid" DPIs containing lactose [11]. However, a meagre few case reports [12][13][14][15][16] over the last two decades described patients with CMPA who developed an allergic reaction due to lactosecontaining DPIs and thus advised against their use in asthmatic subjects with CMPA. ...
Introduction: Several dry-powder inhalers (DPIs) contain lactose which may be contaminated with milk proteins. Confusion exists pertaining to DPI use in patients with cow’s milk protein allergy (CMPA). Methods: A computerized survey sent via e-mail to pediatric pulmonologists and allergologists. Results: A total of 77 out of 232 (33.2%) doctors replied, of whom 80.5% were pediatric pulmonologists. A total of 69 of 77 (89.6%) were specialists, 37.6% with more than 15 years of experience. The most commonly used DPIs were formoterol + budesonide and vilanterol + fluticasone. A total of 62 out of 77 (80.5%) responders knew these DPIs contained lactose. A total of 35 out of 77 (45.5%) doctors who replied did not know that DPI leaflets list CMPA as a contra-indication to DPI administration. Of these, 4 (11.4%) stated that they would instruct patients with CMPA to stop DPIs, and 7 (20%) would avoid recommending DPIs. A total of 42 out of 77 (54.5%) responders were aware of this warning, yet 13 of these 42 (30.9%) continued to recommend lactose-containing DPIs without hesitation and 18 of these 42 (42.8%) responders prescribed DPIs but considered allergy severity. Conclusions: Almost half of certified, experienced pediatric pulmonologists and allergologists were unaware of the warning to administer DPIs to patients with CMPA. Most doctors who do know of this warning still continue to prescribe these DPIs.
... Several excipients have been suggested to trigger the production of specific IgE antibodies and cause mast cell activation [65]. Patients with specific IgE antibodies against vaccine antigens may have higher risks of hypersensitivity reactions [66]. Several studies have attributed the development of hypersensitivity to increased specific IgE levels towards vaccine antigens. ...
As the world deals with the COVID-19 pandemic, vaccination remains vital to successfully end this crisis. However, COVID-19-vaccine-induced immediate hypersensitivity reactions presenting with potentially life-threatening systemic anaphylactic reactions are one of the reasons for vaccine hesitancy. Recent studies have suggested that different mechanisms, including IgE-mediated and non-IgE-mediated mast cell activation, may be involved in immediate hypersensitivity. The main culprits triggering hypersensitivity reactions have been suggested to be the excipients of vaccines, including polyethylene glycol and polysorbate 80. Patients with a history of allergic reactions to drugs, foods, or other vaccines may have an increased risk of hypersensitivity reactions to COVID-19 vaccines. Various strategies have been suggested to prevent hypersensitivity reactions, including performing skin tests or in vitro tests before vaccination, administering different vaccines for the primary and following boosters, changing the fractionated doses, or pretreating the anti-IgE antibody. This review discusses the current trends, potential mechanisms, and prevention strategies for COVID-19-vaccine-induced immediate hypersensitivity reactions.
... MMR, rabies, varicella-zoster, oral typhoid contain the highest concentrations of gelatine whereas DTP and influenza vaccines contain less, and vaccines with higher gelatine concentration carry higher allergy risks. 7,8 In children, both immediate and nonimmediate systemic allergic reactions were reported with gelatine containing vaccines such as anaphylaxis, urticaria, systemic and local eruptions. [9][10][11] Prevalence of gelatine allergy appears to be higher in Japanese children, perhaps due to HLA DR 9, common in that population. ...
Background:
Vaccination is one of the most effective public health tools to prevent a variety of infectious diseases. However, concerns about vaccine related adverse effects cause difficulties in clinical practice.
Methods:
This review was prepared based on the latest literature available in the PUBMED database in English language (as of March 2021), and all articles with the keywords pediatric vaccine, allergy, hypersensitivity, adverse reaction were evaluated to prepare the article.
Results:
Vaccine related confirmed allergic reactions are rare in children, ranging between 0,65-1.45 cases per million vaccine doses. Most of the allergic reactions are self-limited local reactions although in some cases severe anaphylaxis with multisystem involvement can be observed. Allergic reactions may occur because of either the active component (the antigen) of the vaccine, or additional components, such as preservatives, adjuvants, antimicrobials, stabilizers and other substances. Finding the culprit allergen is necessary to prevent future exposure to the allergen and to use alternative vaccines if possible. Diagnosis is largely based on a detailed history and clinical manifestation; also in vivo and in vitro tests may be helpful.
Conclusions:
In this review we provide information about hypersensitivity reactions to allergen components of childhood vaccines along with the diagnosis and management of vaccine allergy. Besides the tremendous benefits of vaccination for the health of children, we emphasized that the risk of adverse effects is rare and poses a negligible threat.
... It should be noted that soy lecithin can contain residual soy protein, which could provoke allergic reactions. Nevertheless, soy lecithin is present in several marketed pharmaceuticals, among which liposomal amphotericin B, and reports of allergic reactions in patients with soy allergy are rare and largely unsubstantiated, and in general, such patients need not to avoid these products (Kelso, 2014). Furthermore, it is noteworthy that, in addition to functional properties, including the improvement of the bioavailability of the incorporated compounds, liposomes have completely natural compositions, which can eliminate or reduce issues related to their inclusion in food systems. ...
The aim of this study was to develop an innovative sheep cheese enriched with Thymus capitatus L. essential oil (EO) nanoincorporated into small homogeneous liposomes. The latter were prepared using two types of lecithin: one commonly used for liposome production, and the other used as dietary supplement. Both EO liposomes, which showed similar physico-chemical characteristics (i.e., size, homogeneity, surface charge), were incorporated into fresh sheep cheese. These enriched sheep cheeses were produced in Sardinia (Italy) and analysed 20, 60 and 180 days after preparation. HS-SPME at 40 and 80 °C coupled with GC-MS/FID method was used to evaluate the volatile fraction and identify the main compounds of both EO and cheese. A validated HPLC-DAD analysis allowed the identification and quantification of thymol and carvacrol, and thymol amount dosed at 20 days was the highest (9.51–10.10 mg/kg). The amount of monoterpenoid phenols and the antiradical and total antioxidant capacity evaluated by FRAP and DPPH• assays, decreased linearly (r ≥ 0.93, p ≤ 0.05) as the cheese maturation increased. Overall results suggested that sheep cheese enriched with T. capitatus EO nanoformulations had an enhanced antioxidant activity compared to cheese without liposomal EO, up to 180 days.
... Looking for excipient allergy has been part of standard practice for reactions caused by foods such as gelatin, egg, or milk, when they are present as an excipient in medications or self-care products. [140][141][142][143][144][145][146] Further, galactose-alpha-1,3-galactose, colloquially known as alpha-gal, was discovered as an allergen primarily because of its presence as an unintended molecule in the drug cetuximab before its role in red meat allergy became clear. 133 The most pressing clinical issues in excipient allergy, therefore, are those excipients that are not routinely encountered outside of medications, the scope to which their allergies are a problem in the population, and how to approach such allergies in clinical practice and research. ...
Excipients are necessary as a support to the active ingredients in drugs, vaccines and other products and they contribute to their stability, preservation, pharmacokinetics, bioavailability, appearance and acceptability. For both drugs and vaccines these are rare reactions however for vaccines they are the primary cause of immediate hypersensitivity. Suspicion for these “hidden dangers” should be high in particular when anaphylaxis has occurred in association with multiple chemically distinct drugs. Common excipients implicated include gelatin, carboxymethylcellulose (CMC), polyethylene glycols (PEG) and products related to PEG in immediate hypersensitivity reactions (IHRs); and propylene glycol (PG), in delayed hypersensitivity reactions (DHRs). Complete evaluation of a suspected excipient reaction requires detailed information from the product monograph and package insert to identify all ingredients that are present and to understand the function and structure for these chemicals. This knowledge helps develop a management plan that may include allergy testing to identify the implicated component and to give patients detailed information for future avoidance of relevant foods, drugs and vaccines. Excipient reactions should be particularly considered for specific classes of drugs where they have been commonly found to be the culprit (e.g. corticosteroids, injectable hormones, immunotherapies, monoclonal antibodies, and vaccines). We provide a review of the evidence-based literature outlining epidemiology and mechanisms of excipient reactions and provide strategies for heightened recognition and allergy testing.
... Patients can experience adverse events triggered by a wide range of substances designated as inactive ingredients. For example, a small number of patients are allergic to inactive ingredients, typically food derivatives, dyes, or preservatives (4)(5)(6)(7). Patients with celiac disease or gluten sensitivity may experience adverse effects by gluten-containing inactive ingredients (8,9). Artificial or fermentable sugars can further cause gastrointestinal distress in intolerant patients or those with irritable bowel syndrome (10). ...
Purpose
A multitude of different versions of the same medication with different inactive ingredients are currently available. It has not been quantified how this has evolved historically. Furthermore, it is unknown whether healthcare professionals consider the inactive ingredient portion when prescribing medications to patients.
Methods
We used data mining to track the number of available formulations for the same medication over time and correlate the number of available versions in 2019 to the number of manufacturers, the years since first approval, and the number of prescriptions. A focused survey among healthcare professionals was conducted to query their consideration of the inactive ingredient portion of a medication when writing prescriptions.
Results
The number of available versions of a single medication have dramatically increased in the last 40 years. The number of available, different versions of medications are largely determined by the number of manufacturers producing this medication. Healthcare providers commonly do not consider the inactive ingredient portion when prescribing a medication.
Conclusions
A multitude of available versions of the same medications provides a potentially under-recognized opportunity to prescribe the most suitable formulation to a patient as a step towards personalized medicine and mitigate potential adverse events from inactive ingredients.
... 5 Gelatin in vaccines can also be a concern for patients with a gelatin allergy. 15 However, some patients with a gelatin allergy may still tolerate vaccinations given the low dose of antigen. Most other excipients, such as lactose in medications or oils in skin care products are considered safe. ...
Optimal management of food allergy is complex and multifaceted. Management of food allergy includes ensuring proper diagnosis, monitoring for the emergence of natural tolerance, screening for nutritional and psychosocial issues, and educating the patient and family on living with food allergies across childhood. Education must encompass successfully avoiding the trigger food, recognizing and treating allergic reactions, and navigating living with food allergies. Allergists can help families prepare for specific situations, such as working with daycares, schools, after-school activities and camps, traveling, and dining out. In addition, psychosocial issues such as anxiety and bullying should be addressed, and counseling with regard to emerging therapies discussed. Managing children with food allergies requires continual follow up with regard to these issues, and the needs of families will change over time. Allergists can guide the family as the child grows and transitions to adulthood when managing food allergy.
... Both the patients and their families must be provided with psychological support. [37] Medical social workers must be made available in both ED and intensive care units to talk to all patients and their family who sustained trauma, provide them supportive counseling, grief counseling, and help expand their social support. In patients with prolonged hospitalization, early recognition and timely intervention of posttraumatic stress disorder, acute stress disorder, or other psychiatric disorders are of paramount importance in the patient's recovery. ...
... From the pharmaceutical point of view, an excipient is an inert substance added to a drug to change solubility or absorption kinetics, improve stability, influence palatability, or create a distinctive appearance. Some pharmaceutical excipients are foods or substances derived from foods (eg, casein, lysozyme), which could pose a threat to patients with food allergy [2,3]. Immediate hypersensitivity reactions (IHRs) to excipients may lead to a false-positive diagnosis of drug allergy [4]. ...
The European Medicines Agency defines excipients as the constituents of a pharmaceutical form apart from the active substance. Immediate hypersensitivity reactions (IHRs) caused by excipients contained in the formulation of medications have been described. However, there are no data on the prevalence of IHRs due to drug excipients. Clinical manifestations of allergy to excipients can range from skin disorders to life-threatening systemic reactions. The aim of this study was to review the literature on allergy to pharmaceutical excipients and to record the IHRs described with various types of medications, specifically reactions due to the excipients contained in their formulations. The cases reported were sorted alphabetically by type of medication and excipient in order to obtain a list of the excipients most frequently involved for each type of medication.
... These allergens may induce allergic diseases such as asthma, Allergic Rhinitis (AR) and Atopic Dermatitis (AD). Ingested allergens are thought to play an important role in the development and worsening the clinical symptoms in patients with atopy [1][2][3]. ...
... There are clearly cases of eosinophilic pneumonitis after repeated daily injections of sesame oil [29], but this results from delayed hypersensitivity to significant amounts of absorbed oil and not immediate hypersensitivity-mediated acute allergic reaction. The antigens in sesame oil capable of causing dangerous acute allergic reactions are present in crude sesame oil, but not in oil refined for pharmaceutical use and most injectable pharmaceutical products in sesame oil do not include allergy risk as a contraindication or potential adverse effect in product information [30]. No documented cases of dangerous acute allergic reaction to pharmaceutical sesame oil were found in the literature, and thus this risk deserves reconsideration. ...
Abstract Background The potential benefits of long-acting injectable chemoprotection (LAI-C) against malaria have been recently recognized, prompting a call for suitable candidate drugs to help meet this need. On the basis of its known pharmacodynamic and pharmacokinetic profiles after oral dosing, ELQ-331, a prodrug of the parasite mitochondrial electron transport inhibitor ELQ-300, was selected for study of pharmacokinetics and efficacy as LAI-C in mice. Methods Four trials were conducted in which mice were injected with a single intramuscular dose of ELQ-331 or other ELQ-300 prodrugs in sesame oil with 1.2% benzyl alcohol; the ELQ-300 content of the doses ranged from 2.5 to 30 mg/kg. Initial blood stage challenges with Plasmodium yoelii were used to establish the model, but the definitive study measure of efficacy was outcome after sporozoite challenge with a luciferase-expressing P. yoelii, assessed by whole-body live animal imaging. Snapshot determinations of plasma ELQ-300 concentration ([ELQ-300]) were made after all prodrug injections; after the highest dose of ELQ-331 (equivalent to 30 mg/kg ELQ-300), both [ELQ-331] and [ELQ-300] were measured at a series of timepoints from 6 h to 5½ months after injection. Results A single intramuscular injection of ELQ-331 outperformed four other ELQ-300 prodrugs and, at a dose equivalent to 30 mg/kg ELQ-300, protected mice against challenge with P. yoelii sporozoites for at least 4½ months. Pharmacokinetic evaluation revealed rapid and essentially complete conversion of ELQ-331 to ELQ-300, a rapidly achieved (
... There are clearly cases of eosinophilic pneumonitis after repeated daily injections of sesame oil (27), but this results from delayed hypersensitivity to significant amounts of absorbed oil and not immediate hypersensitivity-mediated acute allergic reaction. The antigens in sesame oil capable of causing dangerous acute allergic reactions are present in crude sesame oil, but not in oil refined for pharmaceutical use and most injectable pharmaceutical products in sesame oil do not include allergy risk as a contraindication or potential adverse effect in product information (28). We were unable to find any documented cases in the literature of dangerous acute allergic reaction to pharmaceutical sesame oil, and would argue that it should not be ruled out on the basis of allergy risk. ...
Background: The potential benefits of long-acting injectable chemoprotection (LAI-C) against malaria have been recently recognized, prompting a call for suitable candidate drugs to help meet this need. On the basis of its known pharmacodynamic and pharmacokinetic profiles after oral dosing, ELQ-331, a prodrug of the parasite mitochondrial electron transport inhibitor ELQ-300, was selected for study of pharmacokinetics and efficacy as LAI-C in mice.
Methods: Four trials were conducted in which mice were injected with a single intramuscular dose of ELQ-331 or other ELQ-300 prodrugs in sesame oil with 1.2% benzyl alcohol; the ELQ-300 content of the doses ranged from 2.5 to 30 mg/kg. Initial blood stage challenges with Plasmodium yoelii were used to establish the model, but the definitive study measure of efficacy was outcome after sporozoite challenge with a luciferase-expressing P.yoelii, assessed by whole-body live animal imaging. Snapshot determinations of plasma ELQ-300 concentration ([ELQ-300]) were made after all prodrug injections; after the highest dose of ELQ-331 (equivalent to 30 mg/kg ELQ-300), both [ELQ-331] and [ELQ-300] were measured at a series of timepoints from 6 hours to 5.5 months after injection.
Results: A single intramuscular injection of ELQ-331 outperformed four other ELQ-300 prodrugs and, at a dose equivalent to 30 mg/kg ELQ-300, protected mice against challenge with P. yoelii sporozoites for at least 4.5 months. Pharmacokinetic evaluation revealed rapid and essentially complete conversion of ELQ-331 to ELQ-300, a rapidly achieved (< 6 hours) and sustained (4-5 months) effective plasma ELQ-300 concentration, maximum ELQ-300 concentrations far below the estimated threshold for toxicity, and a distinctive ELQ-300 concentration vs. time profile. Pharmacokinetic modeling indicates a high-capacity, slow-exchange tissue compartment which serves to accumulate and then slowly redistribute ELQ-300 into blood, and this property facilitates an extremely long period during which ELQ-300 concentration is sustained above a minimum fully-protective threshold (60-80 nM).
Conclusions: Extrapolation of these results to humans clearly predicts that ELQ-331 should be capable of meeting and far-exceeding currently published duration-of-effect goals for antimalarial LAI-C. Allometric scaling from mice to humans would predict a several-fold enhancement in the relationship between duration-of-effect and dose, and available drug engineering and formulation technologies would be expected to offer significant improvement over the simple powder in sesame oil used here. Furthermore, the distinctive pharmacokinetic profile of ELQ-300 after treatment with ELQ-331 may facilitate durable protection using a variety of delivery and formulation options, and may enable protection for far longer than 3 months. Particularly in light of the favorable pharmacodynamic profile of ELQ-300, ELQ-331 warrants consideration as a leading prototype for LAI-C.
... En el caso de los medios de contraste yodados, no está claro cual es el antígeno causante de la reacción de hipersensibilidad, pero está claro que no es el yodo (33), incluso se ha postulado que el mecanismo no está mediado por IgE, sino que sería dependiente de la hiperosmolaridad (34). Es decir, nunca se ha demostrado la participación del yodo en las reacciones de hipersensibilidad a los "compuestos yodados". ...
RESUMEN
En anestesiología, como en otras especialidades, existen muchos conceptos que damos por verdaderos sin haber analizado la evidencia científica que los apoya o refuta. El objetivo de esta revisión es evaluar la evidencia detrás de algunas “verdades” bastante difundidas, entre ellas, la relación entre alergia al huevo o soya y el uso del propofol; la superioridad de la anestesia regional en cirugía de cadera; el concepto de “alergia al yodo”; el dolor crónico postoperatorio; efectos a largo plazo de la anestesia y efectos dañinos de los anestésicos en el sistema nervioso. Para ello, se realizó una revisión no sistemática de la literatura, mostrando algunos trabajos que apoyen o refuten dichas creencias.
... Furthermore, they are taught to recognise the name and synonyms of allergens, as well as other designations for milk proteins, that may be present in any beverages, food products or candy [4]. Nevertheless, this concern is usually neglected regarding drugs, although in some countries, specific legislation has been achieved for labelling allergens in drug formulations [5,6]. ...
... Anaphylaxis to sesame oil has been reported in several patients mostly confirmed with challenge, even by mere lip mucosal touch in some patients (61,62). However, refined sesame oil used in medications is generally nonallergenic unless contaminated with residual protein (63). Delayed hypersensitivity attributed to sesame oil in progesterone was reported in a patient who developed respiratory symptoms several days after receiving the injection (64). ...
Several seeds have been increasingly incorporated in various food items, with consequent risk of hypersensitivity reactions that are often severe. Identification of the specific seed as the culprit is often not explored or is difficult to verify. In this article, we reviewed the English literature from January 1930 to March 2016 using PubMed and Google Scholar searching for publications relevant to hypersensitivity to common edible seeds, namely sesame, sunflower seed, poppy seed, pumpkin seed, flaxseed, and mustard seed. Considering the worldwide consumption of those seeds, the number of published articles on the subject was relatively small and were mainly as case reports rather than large series. Allergy to sesame was more reported than to other seeds, with an estimated prevalence of 0.1-0.2%. In this review we summarize the information relevant to each of the 5 seeds and their oils regarding the manifestations, routes of exposure, identified major allergens, and cross-reactivity with other seeds or other foods. We also addressed the role of a thorough history-taking in suspecting seed allergy, the limited reliability of routine diagnostic procedures, and the importance of verification by appropriate challenge tests. At present, management is basically dietary avoidance and the use of symptomatic medications that may include epinephrine auto-injectors. We did not encounter any well-designed studies on immunotherapy for seed allergy, but it is hoped that such a gap be filled by the development of safe effective protocols in the near future. This article is protected by copyright. All rights reserved.
... Because propofol contains egg phospholipids and soybean oil, it is contraindicated in patients with egg or soy allergy (2). Although egg phospholipids and soybean oils are not thought to be allergenic (3,4), there remains a theoretical risk of crosscontamination with egg or soy protein and case reports implicate propofol as the inciting trigger for immunoglobulin E (IgE)-mediated reactions in some patients with egg or soy allergy (5)(6)(7). In contrast, some studies and clinical practice suggest that propofol is safe to use in patients with these allergies (8,9). ...
Propofol is a safe, well-tolerated anesthetic that is labeled as contraindicated in patients with egg or soy allergy. This contraindication has become increasingly problematic given the rising incidence of food allergy and eosinophilic esophagitis (EoE). To address this issue, we studied practice patterns of propofol use for esophagogastroduodenoscopies (EGD) in children with EoE and food allergies at our institution. A retrospective observational study of 1365 EGDs from January 2013 to June 2014 was performed. Data was analyzed using student t-tests, chi square tests, Fisher's exact tests, and multivariable logistic regression. We found that propofol was used significantly less in patients with egg or soy allergy, as well as in patients with EoE, even after adjusting for the presence of food allergy. There was no difference in complication rates relative to propofol use. Propofol was used safely in pediatric patients with EoE and food allergy in this limited single-center review.
Food allergies are a common and serious cause of illness, accounting for an increasing number of emergency department visits annually. Although definite diagnosis lays outside of an emergency department visit, the clinical management of the most serious food allergies highlights emergency care. The staple of acute care remains epinephrine in association with antihistamines and steroids. The greatest threat remains undertreatment for this group of disorders and underutilization of epinephrine. Those who have been treated for a food allergy need a follow-up allergist evaluation, guidance of food avoidance, and avoidance of foods with cross-sensitivities as well as ready access to epinephrine.
Background:
Pill crushing is a common practice in patient care settings. Crushing pills can disperse particulate matter (PM) into indoor air. The PM is a widespread air pollutant composed of microscopic particles and droplets of various sizes and may carry active and/or inactive ingredients nurses can inhale. This study aimed to quantify PM sizes and concentration in indoor air when pills are crushed and examine the role of a fume hood in reducing particulate pollution.
Methods:
Two scenarios (with and without a fume hood) representing nurses' pill-crushing behaviors were set up in a positive-pressure cleanroom. Two acetaminophen tablets (325 mg/tablet) were crushed into powder and mixed with unsweetened applesauce. The PM sizes and concentrations were measured before and during crushing.
Results:
Different sizes of PM, including inhalable, respirable, and thoracic particles, were emitted during medication crushing. The total count of all particle sizes and mass concentrations of particles were significantly lower during crushing when a fume hood was used (p = .00).
Conclusion:
Pill crushing increases PM and should be considered a workplace safety health hazard for nurses. Healthcare professionals should work under a fume hood when crushing pills and wear proper protective equipment. The findings of significant particulate pollution related to pill crushing suggest that further research is warranted.
Resumen: Actualmente en Costa Rica, el acceso a la información sobre contenido de gluten, lactosa y otros alérgenos en medicamentos es limitada, lo que dificulta el uso seguro de éstos por parte de las personas con condiciones de salud asociadas a estas sustancias. La presente investigación tuvo el objetivo de promover el conocimiento sobre la presencia de gluten, lactosa y otros alérgenos en los medicamentos en Costa Rica, así como describir las intervenciones farmacéuticas requeridas en la atención de las ya mencionadas personas, mediante el análisis de las consultas relacionadas con este tema presentadas al Centro Nacional de Información de Medicamentos (CIMED), lo cual no había sido previamente reportado en nuestro país. Se tomaron en cuenta las 182 consultas sobre la presencia de gluten y otros alérgenos en medicamentos que se
realizaron al CIMED entre febrero de 2021 y marzo de 2022 y cuya información quedó registrada en la base de datos interna del Centro. Los resultados indican que la presencia de gluten en los medicamentos registrados fue muy baja; sin embargo, en el 40% de los medicamentos en los que la información sobre la lactosa estaba disponible resultaron positivas. Asimismo, se consideró oportuno implementar intervenciones
de atención farmacéutica en muchos casos, entre las cuales destacó la educación sanitaria. Como conclusión, las personas con condiciones de salud vinculadas con gluten, lactosa y otros alérgenos evidencian una clara necesidad de fuentes de información veraz sobre su contenido en medicamentos, por lo que es necesario
incorporar en la normativa de su etiquetado la declaración de contenido de excipientes alérgenos utilizados en la fabricación, así como fortalecer las labores de atención farmacéutica que favorecen, entre otros beneficios, un uso más seguro de sus medicamentos.
Food additives have been used since ancient times. Naturally occurring and derived or synthetic compounds have been used to amend taste, texture, color, appearance, and preservation of foods. Additives are consumed daily in forms of foods and pharmaceuticals and are easy targets for food or ingestion associated adverse reactions. Adverse reactions to additives include urticaria, angioedema, asthmatic and anaphylactic reactions. While the concern of additive-induced reactions exist, IgE-mediated and immunological reactions are quite rare with prevalence 1–2%. In this chapter, we discuss and describe adverse reactions to food additives. We also highlight studies that attempt to address potential molecular mechanisms of food reactions. Finally, we also review and provide specifics for how to evaluate and diagnose potential food allergies in the clinic.
Background
Sesame allergy has been characterized in the Middle East for some time, but has become more widely recognized as foods containing sesame and sesame seeds have become more widely available in Australia, Europe, and North America. With the passage of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act in 2021, the United States will join other countries in identifying sesame as a major food allergen and will require sesame to be labeled as a food allergen beginning in 2023.
Objective
To review the literature related to sesame allergy as an increasingly recognized food allergen around the world.
Data sources
English-language articles obtained through PubMed searches with relevance to sesame allergy.
Study selections
Articles were included using the search terms “sesame allergy” and “sesame seed allergy”
Results
A total of 69 relevant articles were selected regarding sesame allergy relating to its prevalence, clinical presentation, natural history, allergenic epitopes, diagnosis, and treatment.
Conclusion
In recent decades significant gains have been made in determining prevalence and natural history of sesame allergy. With increased recognition and prevalence come the need for reliable methods of identification of sesame allergy as well as approaches to management.
Food allergies are a common and serious cause of illness, accounting for an increasing number of emergency department visits annually. Although definite diagnosis lays outside of an emergency department visit, the clinical management of the most serious food allergies highlights emergency care. The staple of acute care remains epinephrine in association with antihistamines and steroids. The greatest threat remains undertreatment for this group of disorders and underutilization of epinephrine. Those who have been treated for a food allergy need a follow-up allergist evaluation, guidance of food avoidance, and avoidance of foods with cross-sensitivities as well as ready access to epinephrine.
Foods and specific nutrients can affect drug levels, half-life, clinical efficacy, and toxicity through increasing or decreasing gastrointestinal absorption, reducing or enhancing drug metabolism or excretion. Some drugs affect vitamin stores or may cause mineral or trace element deficiencies. Available information about drug–nutrient interactions of those medicinal drugs that tend to be used in chronic kidney disease (CKD) patients is reviewed with a focus on mechanisms. Nutrient interactions with specific and novel drugs (including newer potassium and phosphorus binders, novel oral anticoagulants, and hepatitis C antiretrovirals) that are prescribed to patients with CKD1–5D are also reviewed, and some general rules for the administration of oral drugs through feeding tubes are provided. Interactions between drug excipients and nutrients are mentioned. Drug–nutrient interactions are underinvestigated and surprisingly little is known about interactions with nutrients of commonly used medications in general and even more so for renal disease-specific drugs.
Food additives are naturally occurring or synthetic substances that are added to food to modify the color, taste, texture, stability, or other characteristics of foods. These additives are ubiquitous in the food that we consume on a daily basis and, therefore, have been the subject of much scrutiny about possible reactions. Despite these concerns, the overall prevalence of food additive reactions is 1‐2%, with a minority of the wide variety of symptoms attributed to food-additive exposure being reproduced by double-blind placebo controlled challenges. Reactions can be broadly classified into either immunoglobulin E (IgE)- and non‐IgE-mediated reactions, with natural additives accounting for most IgE-mediated reactions, and both natural and synthetic additives being implicated in the non‐IgE-mediated reactions. Reactions that include asthma exacerbations, urticaria and/or angioedema, or anaphylaxis with ingestion of a food additive are most deserving of further allergy evaluation. In this article, we discussed the different types of adverse reactions that have been described to various food additives. We also reviewed the specifics of how to evaluate and diagnose a food additive allergy in a clinic setting.
Purpose
Propofol is an intravenous sedative used in many patient populations and care settings. Although generally considered safe and effective, the drug has historically been avoided in patients with reported allergies to egg, soy, and/or peanut on the basis of the manufacturer’s prescribing information. Concerns exist for potential adverse events, increased medication costs, reduced efficacy, and risk of medication errors when using alternative agents. Here we present a critical examination of the literature concerning cross-reactivity of food allergies with propofol to provide evidence-based recommendations for the evaluation and management of potential allergic reactions.
Summary
Literature regarding the history of propofol allergy warnings and clinical trial data were assessed to provide an alternative perspective on avoidance of propofol in patients with food allergies. Suspected trigger molecules are discussed with evaluation of the antigenic potential of excipient ingredients used in the manufacture of multiple propofol formulations. Evidence-based recommendations are provided for pharmacist-led screening of adult patients with reported food allergies to support selection of propofol or alternative therapy.
Conclusion
There is a lack of definitive evidence that propofol must be routinely avoided in patients with reported allergies to egg, soy, and/or peanut products. Data from clinical trials suggest that propofol is safe for patients with nonanaphylactic food allergies. Patients who do experience allergic reactions following administration of propofol should undergo further testing to definitively identify the specific trigger and prevent future unnecessary avoidance of preferred medication regimens. Pharmacists can play an important role in interviewing patients with reported food allergies to better determine the risk vs benefit of propofol avoidance.
Lactose contains only trace amounts of cow's milk protein but, in rare cases, children with cow's milk allergy experience an immediate allergic reaction to lactose present in processed foods. Here, we report the case of an 11-month-old milk-allergic child, who tested positive for lactose by an oral challenge test, suspected of undergoing an immediate allergic reaction to lactose contained within Chinese soup. Her medical history revealed an outbreak of hives at 8 months of age after eating a small amount of yogurt. Blood tests revealed high levels of milk-specific IgE and she was diagnosed with cow's milk allergy. Her parents were advised to completely exclude cow's milk and dairy products from her diet. However, after eating Chinese soup for the first time at nursery school, she presented with urticaria and hoarseness at our emergency department. We performed an oral challenge test and the result was positive for lactose of pharmaceutical use. Patients with cow's milk allergy rarely experience an immediate allergic reaction to lactose, so such patients are not generally advised to avoid lactose. When patients are suspected of having lactose-induced symptoms, it is important to confirm this intolerance by an oral challenge test. If a positive result is obtained, patients and their families should be advised about the lactose-containing foods and medicines to avoid.
Epidiolex ® (cannabidiol, aka CBD) is a recently approved FDA prescription drug for the treatment of epilepsy associated with Lennox‐Gastaut and Dravet syndromes, and is increasingly used for treatment‐resistant epilepsy. Rash was rarely reported in Epidiolex ® clinical trial data. We report a case of Epidiolex ® ‐related skin rash that developed in a delayed fashion in a 23‐year‐old female with medically refractory epilepsy. We also review the potential mechanism of Epidiolex ® ‐related skin rash.
Objectives:
Documentation of allergies in a coded, non-free-text format in the electronic health record (EHR) triggers clinical decision support to prevent adverse events. Health system-wide patient safety initiatives to improve EHR allergy documentation by specifically decreasing free-text allergy entries have not been reported. The goal of this initiative was to systematically reduce free-text allergen entries in the EHR allergy module.
Methods:
We assessed free-text allergy entries in a commercial EHR used at a multihospital integrated health care system in the greater Boston area. Using both manual and automated methods, a multidisciplinary consensus group prioritized high-risk and frequently used free-text allergens for conversion to coded entries, added new allergen entries, and deleted duplicate allergen entries. Environmental allergies were moved to the patient problem list.
Results:
We identified 242,330 free-text entries, which included a variety of environmental allergies (42%), food allergies (18%), contrast media allergies (13%), "no known allergy" (12%), drug allergies (2%), and "no contrast allergy" (2%). Most free-text entries were entered by medical assistants in ambulatory settings (34%) and registered nurses in perioperative settings (20%). We remediated a total of 52,206 free-text entries with automated methods and 79,578 free-text entries with manual methods.
Conclusions:
Through this multidisciplinary intervention, we identified and remediated 131,784 free-text entries in our EHR to improve clinical decision support and patient safety. Additional strategies are required to completely eliminate free-text allergy entry, and establish systematic, consistent, and safe guidelines for documenting allergies.
Patient safety is the number one priority in health care as safety is considered at every level of a health care organization (e.g., building, equipment, communication, processes for medications, treatments, and surgical procedures). Addressing the welfare of patients can be challenging, yet for some of the most vulnerable patients (e.g., special needs, disabilities and mental and social health issues), even the most routine nursing requests can put them at a safety risk. Simulations provide an opportunity for nursing students and professional nurses with realistic experiences caring for individuals with unique needs, especially when safety is a major concern.
Objective:
To assess the iatrogenic risks of gelatin allergy and identify resources for patient management.
Data sources:
A literature review was performed using PubMed and public databases provided by the National Library of Medicine.
Study selections:
Reports of iatrogenic gelatin allergy associated with vaccines, hemostatic agents, intravenous colloids, medicinal capsules, and intraoperative surgical supplies.
Results:
Gelatin ingredients may not be identified by electronic medical record safeguards, and an exhaustive listing of potential iatrogenic exposures is elusive. The National Library of Medicine AccessGUDID (https://accessgudid.nlm.nih.gov/) can be a useful resource in evaluating medical devices for gelatin content. Unexpected sources of iatrogenic gelatin exposure include hemostatic agents, vascular grafts, intravascular cannulas, bone replacement implants, and emergency resuscitation fluids.
Conclusion:
Vigilance is important within medical systems to avoid inadvertent gelatin exposure when caring for patients with gelatin allergy. Additional safeguards are needed to remove latent health care system errors that fail to prevent gelatin administration in this at-risk population.
Impfreaktionen bedingt durch Allergien gegen das Impfantigen oder enthaltene Hilfsstoffe wie Hühnereiweiß oder Gelatine sind schon länger bekannt. Neuere Erkenntnisse bezüglich Reaktionen vermittelt über das Kohlenhydratepitop Galaktose-alpha-1,3-Galaktose (Alpha-Gal) als Bestandteil tierischer Gelatine erweitern das Spektrum gelatinebedingter Allergien. In dieser Fallserie werden vier Patienten mit einer anaphylaktischen Reaktion nach einer Tollwutimfpung mit dem Impfstoff Rabipur® vorgestellt. Nach entsprechender allergologischer Testung mittels Pricktestung und Bestimmung des spezifischen IgE auf die im Impfstoff enthaltenen Allergene konnte eine Auslösung durch Alpha-Gal ausgeschlossen und eine Allergie gegenüber Gelatine nachgewiesen werden. Eine fehlende allergische Symptomatik nach dem Verzehr von Gelatine lässt sich eventuell durch die Hydrolyse im Darm und dem damit verbundenen Verlust der Allergenen Potenz erklären. Weitere Implikationen beim Einsatz von gelatinehaltiger Infusionen in der Notfallmedizin werden diskutiert.
Side effects due to allergic reactions to vaccine antigen or to additives such as chicken protein or gelatin have been known for some time. Recent findings regarding reactions mediated via the carbohydrate epitope galactose-alpha-1,3-galactose (alpha-gal), a constituent of animal gelatin, broaden the spectrum of gelatin-related allergies. This case series presents four patients who developed anaphylactic reactions following rabies vaccination using the vaccine Rabipur®. After appropriate allergy testing by skin prick testing and the determination of specific IgE to allergens in the vaccine, triggering by alpha-gal could be excluded and an allergy to gelatin was detected. The absence of allergic symptoms following the consumption of gelatin could potentially be explained through intestinal hydrolysis resulting in a loss of allergenic potency. Further implications related to the use of gelatin-containing infusions in emergency medicine are discussed.
Children with autism spectrum disorder may exhibit issues with food selectivity and/or picky eating habits. Symptoms of autism such as sensory sensitivity contribute to why these children refuse to eat food, but medications, food intolerance, and even financial status can cause this issue to become concerning to a student’s overall health. School nurses are imperative in the health care of children with autism spectrum disorder and must understand why food selectivity occurs in order to maintain or improve the nutrition status of their students. This article provides an overview of food selectivity and where it stems from as well as 10 tips in working with food selective children.
The management of food allergies requires the cooperation of the food allergic person, physician, family, and social contacts. For children, school management of food allergies is a key component of the overall approach. Recognition of the signs and symptoms of allergic reactions and preparation to administer the appropriate treatment of mild and severe symptoms in the event of accidental exposure is necessary. Avoidance of food allergens is facilitated by label reading and dietary guidance is extremely important to minimize nutritional deficiencies. Medications and vaccines with food-derived excipients generally do not need to be avoided because, in most cases, they contain little food protein.
Perioperative anaphylaxis is an iatrogenic clinical condition, most often after anesthetic induction. Several mechanisms are implicated, including IgE- and non–IgE-mediated mechanisms. Perioperative anaphylaxis tends to be severe and has a higher mortality rate than anaphylaxis in other settings. This is partly due to factors that impair early recognition of anaphylaxis. Neuromuscular blocking agents, latex containing products, and antibiotics are the most common etiology. Chlorhexidine and dyes are increasingly culprits. The newest emerging cause is sugammadex, which is used for reversal of the effects of steroidal neuromusclar agents, such as rocuronium. Latex-induced allergy is becoming less common than in the 1980s due to primary and secondary prevention measures. Serum tryptase levels during the time of anaphylaxis and skin testing to suspected agents as an outpatient are necessary to confirm the diagnosis. Management includes epinephrine and aggressive fluid therapy. With radiocontrast media allergy, patients with a history of immediate hypersensitivity reactions to radiocontrast media should receive steroid and antihistamine premedication before re-exposure. Because IgE-mediated anaphylaxis to radiocontrast media is rare, there is a universal consensus that routinely skin testing all patients with a past reaction is not effective.
Although propofol is thought to be a relatively safe intravenous anesthetic with regard to histamine release reactions, anaphylactoid reactions to propofol may sometimes occur, especially in patients with a history of allergy, atopy, or asthma. Here we report a patient with allergies to sesame leaves and cold medications who experienced an anaphylactic reaction with severe oropharyngeal edema a few minutes after receiving propofol (Anepol®). This finding suggests that propofol should be used with caution in patients with a history of allergy. Because profound airway edema can occur, the airway should be evaluated before extubation of the trachea.
The purpose of this statement is to update recommendations for routine
use of seasonal influenza vaccine and antiviral medications for the
prevention and treatment of influenza in children. Highlights for the
upcoming 2013–2014 season include (1) this year’s trivalent influenza
vaccine contains an A/California/7/2009 (H1N1) pdm09-like virus
(same as 2012–2013); an A/Texas/50/2012 (H3N2) virus (antigenically
like the 2012–2013 strain); and a B/Massachusetts/2/2012-like virus
(a B/Yamagata lineage like 2012–2013 but a different virus); (2) new
quadrivalent influenza vaccines with an additional B virus (B/Brisbane/
60/2008-like virus [B/Victoria lineage]) have been licensed by the US
Food and Drug Administration; (3) annual universal influenza immunization
is indicated with either a trivalent or quadrivalent vaccine (no
preference); and (4) the dosing algorithm for administration of influenza
vaccine to children 6 months through 8 years of age is unchanged
from 2012–2013. As always, pediatricians, nurses, and all health care
personnel should promote influenza vaccine use and infection control
measures. In addition, pediatricians should promptly identify influenza
infections to enable rapid antiviral treatment, when indicated, to reduce
morbidity and mortality. Pediatrics 2013;132:e1089–e1104
Background: Anaphylactic reactions to measles, mumps, and rubella vaccines, including gelatin as a stabilizer, have been reported. It had been found that most of these reactions to live vaccines are caused by the bovine gelatin included in these vaccines. Gelatin mainly includes denatured type I collagen, which consists of α1 and α2 chains. Objective: The current study was designed to investigate the IgE reactivity to α1 and α2 chains of bovine type I collagen in gelatin-sensitive children. Methods: Serum samples were taken from 10 children who had anaphylaxis to the vaccines and high levels of specific IgE to bovine gelatin. Bovine type I collagen was isolated from bovine skin and then separated to α1 and α2 chains by column chromatography. IgE reactivity to denatured type I collagen and its α1 and α2 chains was analyzed by immunoblotting, ELISA, and histamine release from the mast cells passive sensitized with IgE antibodies in pooled serum of the children. Results: All children had specific IgE to bovine type I collagen. Furthermore, IgE antibodies in their sera reacted with the alpha;2 chain but not with the α1 chain. Similarly, the mast cells sensitized with pooled sera in the children showed α2 chain-specific histamine release but not α1 chain–specific histamine release. Conclusion: In gelatin allergy denatured bovine type I collagen is a major allergen and IgE-binding sites exist in the α2 chain of type I collagen. (J Allergy Clin Immunol 1999;104:695-9.)
Anaphylaxis to egg or severe egg allergy has been considered a contraindication to receiving trivalent seasonal influenza vaccine (TIV).
To evaluate the safety of TIV among severely egg allergic children.
A 2-phase, multicenter study at 7 sites was conducted between October 2010 and March 2012. Inclusion criteria included a history of a severe reaction, including anaphylaxis, to the ingestion of egg and a positive skin test result or evidence of serum specific IgE antibody to egg. Phase 1 consisted of a randomized, prospective, double-blind, placebo controlled trial of TIV administration to egg allergic children, using a 2-step approach; group A received 0.1 mL of influenza vaccine, followed in 30 minutes if no reaction with the remainder of an age-appropriate dose, whereas group B received an injection of normal saline followed in 30 minutes if no reaction with the full 100% of the age-appropriate dose. Phase 2 was a retrospective analysis of single dose vs split-dose administration of TIV in eligible study participants who declined participation in the randomized controlled trial.
Thirty-one study participants were prospectively evaluated in the randomized controlled trial (group A, 14; group B, 17); 45.1% had a history of anaphylaxis after egg ingestion. A total of 112 participants were retrospectively evaluated (87 with the single dose and 25 with the split dose); 77.6% of participants had a history of anaphylaxis after egg ingestion. All participants in both phases received TIV without developing an allergic reaction.
TIV administration is safe even in children with histories of severe egg allergy. Use of 2-step split dosing appears unnecessary because a single dose was well tolerated.
There are numerous, disparate guidelines for influenza vaccination in egg-allergic patients. We aimed to describe the outcome of selectively applied guidelines, based on risk-stratification, to our high risk, egg-allergic, tertiary-care pediatric population.
Egg allergy was confirmed with skin testing. The vaccine administered was an adjuvunated 2009 H1N1 influenza A vaccine with < 0.165 mcg/ml ovalbumin. Patients with mild egg allergy were to receive the vaccination in 1 dose, those with severe egg allergy were to receive 2 split doses, and patients with exquisite egg allergy or significant co-morbidities were to be skin tested with the vaccine (prick full strength, intradermal 1:100 of final concentration without adjuvant) and had 5 step desensitization if the testing was positive, or 1-2 step administration if negative. Patients were observed for 60 minutes after the final dose and anaphylaxis treatment was available. We report the frequency of allergic reactions.
Ninety-nine patients were referred and 79 had positive egg testing. Asthma was present in 67% and 30% had prior anaphylaxis to egg. We vaccinated 77 of 79 patients: 71 without performing vaccine skin testing. Two refused vaccination. No patient had a systemic reaction or required treatment. Two patients experienced positive testing to the adjuvanated intradermal vaccine, but were negative without adjuvant.
Our results suggest that most egg-allergic tertiary care pediatric patients can be vaccinated with a low ovalbumin content influenza vaccine without prior vaccine testing. Vaccine skin testing, if used at all, can be reserved for special circumstances. The squalene adjuvant may cause an irritant reaction with intradermal testing.
The Drug Allergy Committee of the Spanish Society of Allergology and Clinical Immunology reviewed the allergenic potential of several substances of food origin that are found in the composition of some drugs. Despite recent legislation on labeling, many labels do not clearly state whether the drug contains raw material (active ingredients, excipient, or other manufacturing intermediate) with an origin in any of the substances in the list of the 14 groups of food allergens that are subject to mandatory declaration. The objective of legislation is that the drug package, the Summary of Product Characteristics, and the patient information leaflet clearly state the food content in order to improve the safety of allergic patients. Therefore, any food or allergen derivative that must be declared should be clearly stated on the drug label. Of all the evaluated products, egg and milk derivatives are the most frequently discussed in literature reviews. The natural or synthetic origin of potentially allergenic substances such as lysozyme, casein, lactose, albumin, phosphatide, and aromatic essences should be clearly stated. Providing this information has 2 clear advantages. First, allergic reactions to drugs in patients with food allergy could be avoided (if the substances have a natural origin). Second, prescription would improve by not restricting drugs containing synthetic substances (which do not usually induce allergic reactions).
Design Retrospective audit.
Setting Secondary paediatric outpatient clinic, Tromsø, Norway.
Participants The participants were 80 (62.5% boys and 37.5% girls) children and adolescents with a diagnosed egg allergy who had to be on an egg-free diet and be unable to eat any food containing any amount of egg, including egg-containing baked goods, without an allergic reaction to egg protein. We also included patients who were sensitised to egg but had never been exposed to egg or egg-containing baked goods and were on an egg-free diet. Other atopic diseases among the study participants were also registered.
Intervention The vaccination took place from November to December 2009. The patients were vaccinated with a monovalent influenza A (H1N1) vaccine that had an ovalbumin content <0.33 μg/ml. They were divided into two groups, receiving the vaccine either as a single dose or as a fractionated dose. Patients were selected for the fractionated dose because of their prior reaction to egg or because they never had been exposed to egg.
Primary outcome There were no serious adverse reactions to the vaccine; only one mild adverse reaction and two possible adverse reactions.
Results Patients ranged in age from 10 months to 16.5 years. Thirty-eight (48%) patients received a fractionated dose. Sixty-three (79%) had one or more atopic disease apart from egg allergy. With regard to atopy, serum specific IgE levels or skin prick test, there were no significant differences between the groups receiving the vaccine as a fractionated or as a single dose.
Conclusions The study confirmed that patients allergic to egg can be safely vaccinated with a regular influenza vaccine containing <0.333 μg/ml ovalbumin, even if these patients had displayed previous anaphylactic reactions to egg and had been diagnosed with concurrent atopic diseases.
Propofol (2,6-diisopropylphenol) is an ultrashort-acting sedative agent with sedative and amnestic effects that is used not only for anesthesia but also for sedation during minor outpatient procedures and endoscopic examinations. Rare cases of anaphylaxis following propofol administration have been reported in the medical literature. Documentation of anaphylaxis is often lacking because the cause and effect relationship is often hard to prove. Only a minority of patients get referred for allergy testing to confirm the offending drug. Here we report a 74-year-old woman who had an anaphylactic reaction with severe oropharyngeal edema and bronchospasm for a few minutes after receiving propofol during endoscopic examination. An allergy skin test was positive for both propofol and soybean. Soybean in the intralipid is one component of propofol, and we concluded that this anaphylaxis was caused by soybean.
Background
In Canada, the pH1N1 influenza vaccine is recommended for children, particularly those less than 5 years of age or with chronic underlying disease. The pH1N1 vaccine, which contains residual allergenic egg white proteins, may pose a risk for vaccination of egg-allergic children.
Objective
To describe the outcome of pH1N1 influenza vaccine administration to egg-allergic children at risk for severe H1N1 disease.
Design/Method
Prospective observational cohort study. Children identified as at high risk for egg allergy and H1N1 influenza were vaccinated using a two-dose split protocol in a controlled medical setting. Children were given an initial test dose; if no reaction was noted, the remainder of the dose was administered and the children were followed for allergic reactions. Those who tolerated the split dose and required a second dose of vaccine were offered vaccination four weeks later as one injection.
Results
Sixty-two egg-allergic children considered at high risk for H1N1 disease received the adjuvanted pH1N1 vaccine. Egg allergy was diagnosed both clinically by an allergist and using skin and/or serum IgE testing. Within one hour of immunization, 2 children developed hives, 1 had a vasovagal response and 1 had a hypo-responsive episode. Fourteen children received the second H1N1 dose and 1 developed erythema and itching. There were no anaphylactic reactions.
Conclusion
Administration of the adjuvanted pH1N1 vaccine in egg-allergic children at risk for severe H1N1 influenza was safe when performed in a two-dose split protocol in a controlled medical setting.
Excipients have been defined in many ways, including as inert substances used as vehicles and diluents for drugs. The problem with this definition is that in recent years excipients have proved to be anything but inert, not only possessing the ability to react with other ingredients in the formulation, but also to cause adverse and hypersensitivity reactions in patients. These range from a mild rash to a potentially life-threatening reaction. Different brands of the same drug may contain different excipients, especially preservatives and colourants. The Consumer Medicines Information provides a list of excipients, and information on the safety of individual excipients can be found in drug reference guides.
RECENT REPORTS1 indicate that the administration of measles vaccine for active immunization of susceptible children has not yet reached desirable levels, and that 20 million children under the age of 10, living in the United States, are unprotected. Several factors probably account for this, including lack of information, cost of the procedure, and the possibility or fear of reaction. The latter has been specifically related to egg-allergic children, of whom there are conservatively estimated to be over 50,000 among the allergic pediatric population of the United States. Since reactions to virus vaccines have occurred in the past among eggallergic children,2-4 the manufacturers of virus vaccines have routinely cautioned that such children should not receive live, attenuated virus vaccine immunizations.
In a previous study,5 we administered live, attenuated measles virus vaccine to 11 children from 1 to 6 1/2 years of age, each of whom repeatedly demonstrated severe
DURING the first year of life, egg allergy is one of the most common food allergies in atopic children.1 Since the attenuated measles and mumps components of the measles, mumps, and rubella (MMR) virus vaccine (live) are grown in cell cultures of chick embryos, concerns have been raised regarding the safety of administering the MMR vaccine to eggallergic children. Initially, it was believed that egg-allergic children could safely receive the vaccine.2,3 However, it has since become apparent that reactions to the MMR vaccine can occur in egg-allergic individuals.4 The American Academy of Pediatrics recommends that "persons with a history of anaphylactic reactions (eg, urticaria, swelling of the mouth and throat, wheezing, laryngospasm, hypotension, or shock) following egg ingestion should not be vaccinated until they have been skin-tested."5 Because of the effectiveness of vaccines in preventive medicine, ways of safely administering vaccine grown in avian embryos to
• Thirty-five egg-sensitive children who received measles immunization without adverse sequelae are described. Thirty-two of the children had a history of immediate hypersensitivity reactions to egg protein, including 22 who developed a generalized reaction after oral exposure to egg. There were also 3 highly allergic children, with immediate hypersensitivity reactions to other food, who, despite having never been exposed to egg, developed large skin prick test wheals to egg white. Measles vaccine was given to all children without prior vaccine skin testing. There were no adverse reactions. It is suggested that measles vaccine can be given to children with a history of generalized or localized urticaria/angioedema on exposure to egg protein without prior skin testing.
(AJDC. 1990;144:33-35)
Since 1993, there have been several reports describing severe allergic reactions to gelatin. The initial report described a 17-year-old girl who experienced anaphylaxis to MMR vaccine. Subsequent reports followed describing anaphylactic reactions to other gelatin-containing vaccines and medications. This is the first case report of an allergic reaction to influenza vaccine due to gelatin allergy. Although, the incidence of anaphylaxis to gelatin is extremely low (about one case per 2 million doses), gelatin is the most common identifiable cause of severe allergic reaction to vaccines. A review of the literature and management of these patients is discussed.
SINCE the earliest reports1, 2 appeared in the literature describing anaphylaxis and death, as well as minor reactions, to egg protein, physicians have become increasingly aware of the potency of egg protein as an antigen in human atopic disease. These and subsequent reports3, 5 have included reactions not only from ingestion but also especially from injection of egg protein, as contained in egg skin-testing preparations and in viral vaccines produced by culture of live virus in chick embryo. The studies have shown that less than 1% of a random sample of "normal" children have positive skin tests to egg protein, whereas positive skin tests are found in about 20% of allergic children. In a general population of allergic children, 5% are believed to be clinically allergic to egg and will show varying reactions upon ingestion of whole egg. It was also shown and reported by several observers that such children and adults are more likely to
Excipients have been defined in many ways, including as inert substances used as vehicles and diluents for drugs. The problem with this definition is that in recent years excipients have proved to be anything but inert, not only possessing the ability to react with other ingredients in the formulation, but also to cause adverse and hypersensitivity reactions in patients. These range from a mild rash to a potentially life-threatening reaction. Different brands of the same drug may contain different excipients, especially preservatives and colourants. The Consumer Medicines Information provides a list of excipients, and information on the safety of individual excipients can be found in drug reference guides.
The Sabin vaccine is used world-wide, and most children with food allergies receive it without incident. However, in the 2009 vaccination campaign conducted in Argentina, four children experienced immediate-type hypersensitivity reactions following vaccination.
We aimed to review the medical history of the affected children, study their allergic condition after the episodes and analyse the presence of allergenic vaccine components.
Patients were selected based on their immediate allergic reactions following vaccination. They were assessed for allergies to cow's milk and hen's egg. The presence of cow's milk proteins in the vaccine was tested by various immunoassays involving cow's milk- or α-lactalbumin-specific polyclonal rabbit antiserum and patient sera.
All of the patients had a history of milk allergy, and no history or current evidence of egg hypersensitivity was found. Levels of cow's milk- and Sabin vaccine-specific IgE were increased, and the result of a skin prick test with cow's milk proteins or the Sabin vaccine was positive in each patient. In addition, an ELISA using specific rabbit antiserum detected α-lactalbumin in the Sabin vaccine. When α-lactalbumin was employed as a soluble inhibitor in a competitive ELISA, binding to vaccine-coated plates by cow's milk- or α-lactalbumin-specific rabbit antiserum or by patient serum containing IgE was inhibited.
We have demonstrated that these patients were allergic to cow's milk, and had circulating and mast cell-bound IgE antibodies specific to cow's milk proteins. We found that the Sabin vaccine contained α-lactalbumin, which may have been responsible for the reactions elicited following vaccination with the Sabin and dual viral vaccines in combination.
Immediate type-generalized reactions to protamine sulfate are uncommon but may be fatal. The mechanisms of severe or fatal reactions are unknown in most cases. One theory is that contaminating fish (salmon) proteins present in protamine solutions induce anaphylaxis in salmon-sensitive subjects. A second hypothesis is that protamine interacts with anti-salmon IgE to cause anaphylaxis. We assessed these hypotheses by establishing an indirect amplified enzyme-linked immunosorbent assay (ELISA) for IgE to salmon. Sera obtained from two subjects anaphylactically sensitive to salmon demonstrated high binding to salmon that was not inhibited by preincubation of sera with 500 or 1000 [mu]g of protamine or Aspergillus fumigatus. Serum from a patien who experienced anaphylactic shock from protamine was indistinguishable from control sera in the ELISA for IgE to salmon. Anti-protamine IgE could not be demonstrated in separate experiments. The assays prove that 1) serum IgE to salmon is not inhibited by protamine and 2) serum from a patient experiencing a severe reaction to protamine did not contain IgE to salmon or protamine. The experiments do not support the notion that there is cross-reactivity between IgE to salmon and protamine sulfate in the cases evaluated.
(C) Copyright 1989 Southern Society for Clinical Investigation
The use of topical hemostatic agents is widespread and has been shown to reduce bleeding during a wide variety of surgical procedures. Nonetheless, as biologically active agents, there is potential for allergic reactions to these products.
This is a report of intraoperative anaphylaxis to gelatin associated with the use of two topical hemostatic agents.
Case report. There is no outside funding or potential conflict of interest.
A patient with anaphylaxis during anterior spinal fusion.
Laboratory assays for tryptase, gelatin-specific immunoglobulin E (IgE), and total IgE.
A 14-year-old male with myelomeningocele and scoliosis was treated with anterior spinal fusion from T12 to L3. Gelfoam sponges were applied during the preparation of the disc spaces. Approximately 1 hour later, Floseal hemostatic matrix was applied to a briskly bleeding screw hole in the L3 vertebral body, and the patient experienced an abrupt onset of hypotension and ventilatory difficulty. Epinephrine, dexamethasone, and blood products were administered for hemodynamic support while the surgical site was closed. Removal of the drapes revealed a widespread erythematous rash, and the patient was then transferred to the intensive care unit. When stable 3 days later, he returned to the operating room for completion of the spinal fusion.
Postoperative laboratory assays were sent that revealed elevated levels of tryptase, total IgE, porcine, and bovine gelatin-specific IgE. The patient was counseled to avoid gelatin-containing products. At 6-month follow-up, his instrumented spine was radiographically fused and he reported no further allergic issues.
Anaphylaxis may occur because of animal gelatin components of topical hemostatic agents. Previous reports have focused on the thrombin components. Care should be taken in the administration of these products, particularly in the atopic individual.
To cite this article: Martín-Muñoz MF, Fortuni M, Caminoa M, Belver T, Quirce S, Caballero T. Anaphylactic reaction to probiotics. Cow’s milk and hen’s egg allergens in probiotic compounds. Pediatr Allergy Immunol 2012: 23: 778–784.
Background: Probiotics are used in the treatment of allergic diseases. We investigated the safety of probiotics for subjects with food allergy.
Material and methods: Labels of probiotics commercially available in Spain were examined to assess their content of cow’s milk or hen’s egg. Skin prick tests with these compounds (20 mg/ml) were performed in five children allergic to cow’s milk, five children allergic to hen’s white egg, and five control subjects non-allergic to food. Three serum pools: I (positive-specific IgE to cow’s milk and hen’s egg white proteins), II (positive-specific IgE to cow’s milk and negative to hen’s egg white proteins), and III (negative-specific IgE to cow’s milk and positive to hen’s egg white proteins) were used to detect cow’s milk and hen’s egg white allergens in probiotics. ImmunoCAP® (Phadia), in-house ELISA, SDS-PAGE immunoblotting, and inhibition studies of these assays were performed. Proteins were quantified by enzyme-immunoassay.
Results: Eleven probiotics were studied. No label advertised about egg content, eight labels warned about lactose, lactic acid or cow’s milk, one label claimed to be milk-free, and two gave no information. Cow’s milk proteins were detected, by at least one lab technique, in 10/11 probiotics, three over 2.5 mg/kg (21, 52, 112 mg/kg). Hen’s egg white proteins were detected in 3/11 probiotics, only one had more than 2.5 mg/kg (47 mg/kg).
Conclusion: Probiotic compounds may contain hidden allergens of food and may not be safe for subjects with allergy to cow’s milk or hen’s egg.
Measles vaccines are prepared in chick embryo fibroblast culture and used throughout the world. Since 1963 dramatic reductions in the incidence of measles have been observed where the vaccination was extensively applied in the pediatric population. The best results were observed when the target population in the initial phase was that which produced over 90% of cases in the pre-vaccinal era. A possible limiting factor to the diffusion of measles vaccination is the assumption that allergy to egg proteins is a contraindication. In this paper current knowledge about the safety of measles immunization in children with egg allergy is discussed.
Mild local reactions and fever after vaccinations are common and do not contraindicate future doses. Anaphylactic reactions to vaccines are rare and should be evaluated with skin tests to the vaccine and its components. If the skin test results are negative, subsequent doses can be administered in the usual manner but under observation. If the skin test results are positive and the patient requires subsequent doses, the vaccine can be administered in graded doses under observation. Some nonanaphylactic reactions to vaccines might also require evaluation, but only a few are contraindications to future doses. Pregnant women and persons who are immune compromised should generally not receive live vaccines. Purported long-term sequelae of vaccination, such as autism, are not supported by epidemiologic studies. Patients with egg allergy of any severity should receive annual influenza vaccinations because studies have demonstrated a very low rate of reactions. Studies to date have evaluated the injectable trivalent influenza vaccine (TIV), and thus TIV, rather than the live attenuated influenza vaccine (LAIV), should be used for recipients with egg allergy. All influenza vaccines available in the United States contain low amounts of ovalbumin. Neither skin testing with the vaccine nor dividing the dose is required; however, the vaccine should be administered in a setting in which anaphylaxis can be recognized and treated.
