Expert Opinion on Drug Safety

Publisher: Informa Healthcare

Current impact factor: 2.91

Impact Factor Rankings

2016 Impact Factor Available summer 2017
2014 / 2015 Impact Factor 2.911
2013 Impact Factor 2.735
2012 Impact Factor 2.621
2011 Impact Factor 3.015
2010 Impact Factor 2.645
2009 Impact Factor 2.496
2008 Impact Factor 3.073

Impact factor over time

Impact factor
Year

Additional details

5-year impact 2.77
Cited half-life 4.50
Immediacy index 0.70
Eigenfactor 0.00
Article influence 0.84
ISSN 1744-764X

Publisher details

Informa Healthcare

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    • Author can archive a pre-print version
  • Post-print
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  • Restrictions
    • 12 months embargo
  • Conditions
    • On author's personal website or institution website
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    • Non-commercial
    • Must link to publisher version
    • Publisher's version/PDF cannot be used
    • NIH funded authors may post articles to PubMed Central for release 12 months after publication
    • Wellcome Trust authors may deposit in Europe PMC after 6 months
  • Classification
    yellow

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: Primary Sjögren's syndrome (pSS) is a disabling auto-immune disease, affecting exocrine glands and several organs. Areas covered: In this review we analyze the safety of therapies used in pSS. Symptomatic treatment is widely applied due to the good supportive effect and good safety profile. Systemic stimulation of tears and saliva can be successful in pSS. However, cumbersome adverse events can influence the tolerability of this therapy. Evidence for the effectiveness of synthetic DMARDs therapies in pSS is limited, while there is a risk of adverse events. Several studies on biologic DMARD treatment of pSS patients have shown promising efficacy and safety results. Expert opinion: The safety of symptomatic treatment of pSS is very good. However, systemic therapy is necessary to achieve long-term relieve and prevention of organ-damage. Synthetic DMARDs have not shown much efficacy in earlier studies, and their benefits do not weigh up to the possible harms, while biologic DMARDs show promising results regarding efficacy and cause mostly mild adverse events. Many questions remain unanswered regarding safety of DMARDs in pSS. There is a need for well designed studies, in which safety should be evaluated in a uniform manner to be able to compare the results between studies.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Myelosuppression induced by cancer chemotherapy is associated with considerable morbidity and mortality. Febrile neutropenia (FN) represents an oncologic emergency requiring immediate evaluation and treatment. Resulting chemotherapy dose reductions or delays may compromise disease control and survival. While non-Hodgkin lymphoma (NHL) represents a potentially curable malignancy, there are limited data on the risk of neutropenic complications. This review represents a systematic search and evidence summary of neutropenic complications reported in randomized controlled trials (RCTs) published over the past decade in adults with NHL receiving myelosuppressive chemotherapy. Areas covered: Data captured include the chemotherapy regimen and dosing, the type of NHL, sample size, myeloid growth factor (MGF) use, and myelosuppression including FN and severe neutropenia and infection. Expert opinion: Rates of neutropenic complications for commonly utilized chemotherapy regimens vary considerably across studies with FN reported in only one-fourth of study arms. Further challenges in interpreting reported rates are the variable and inconsistent use of MGF support and little or no information on delivered chemotherapy dose intensity. Considerable change in regimens, study populations and reporting of neutropenic events as well as the use of MGF was observed over the decade of RCTs reported. Complete and accurate reporting of treatment-related toxicities in patients receiving cancer chemotherapy is essential in both clinical trials and clinical practice.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Tyrosine kinase inhibitors (TKIs) drastically changed the outcome of patients affected by chronic myeloid leukemia, allowing long-term improved overall survival and deep molecular responses. Areas covered. In this review, all the related and "off target" side effects of different TKIs are reported and reviewed including their pathogenesis, and associated predisposing factors are discussed. Expert Opinion. Appropriate identification of adverse events and classification according to CTC scale is required during therapy with TKI, considering the impact on the long-term quality of life. Specific evaluation and stratification of comorbidities and cardiovascular risk profile at baseline is suggested in order to better tailor individualized treatment strategy and identify patients who require strict monitoring of risk factors during treatment.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Anti-tumor necrosis factor-alpha (TNF-α) therapy has revolutionized the medical treatment of Crohn's disease (CD). Nevertheless, anti-TNF-α therapy has been associated with serious adverse events (SAE) raising safety concerns. This review focuses on the safety profile of anti-TNF-α agents in CD. Areas covered: We performed a literature search until August 2015 to collect safety data on infliximab, adalimumab and certolizumab pegol monotherapy or combined with immunomodulators (IMM). We have mainly focused on infections and malignancies. Safety in pregnancy, the elderly and children are also presented. Expert opinion: Available data in CD suggest that anti-TNF-α monotherapy or in combination with IMM is relatively safe, although it may be associated with an elevated risk of serious infections, skin cancer and lymphoma. However, as this data derive mainly from cohort studies, post-marketing registries, and meta-analyses of RCTs, often characterized by inherited methodological weaknesses that may hinder their validity, data from large, statistically powered, prospective studies of sufficient follow up are required to define the actual risk of SAE during anti-TNF-α therapy in IBD. The role of therapeutic drug monitoring in predicting and preventing SAE awaits confirmation.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction Methicillin-resistant Staphylococcus aureus (MRSA) is a frequent cause of severe nosocomial and community-acquired infections. Various adverse effects have been associated with compounds that are commonly used in the treatment of MRSA. Areas covered Prolonged use of high-dose vancomycin has been linked with nephrotoxicity. Linezolid use has been associated with lactic acidosis in regimens longer than 14 days and occurrence of thrombocytopenia in patients with renal impairment. Daptomycin use correlates with reversible and often asymptomatic myopathy. Among new compounds, telavancin has shown increased toxicity compared to vancomycin, especially in patients with severe renal impairment, while a low rate of adverse effects was reported others glycolipopeptides such as dalbavancin and oritavancin and for new cephalosporins. Recently studied oxazolidinones (tedizolid and radezolid) also showed mild adverse effects in Phase 2 and 3 clinical trials. Expert opinion Due to the constant increase in antimicrobial resistance, the use of higher doses and prolonged regimens of antibiotics employed in the treatment of Gram-positive infections has become more common and linked to increased toxicity. Furthermore, new compounds with MRSA activity have been recently approved and will be regularly employed in clinical practice. The knowledge of the adverse effects and risk factors for the development of toxicity associated with anti-MRSA antimicrobials is paramount for the correct use of old and new compounds, especially in the treatment of severe infections.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Rhabdomyolysis syndrome refers to a variety of factors that affect the striated muscle cell membrane, the membrane channels and its energy supply. Most cases of rhabdomyolysis are due to direct trauma. However, infection, toxins, drugs, muscle ischemia, electrolyte imbalance, metabolic diseases, genetic diseases and abnormal body temperature can also lead to rhabdomyolysis. Epilepsy is one of the most common chronic neurological diseases. The primary long-term treatment is antiepileptic drugs (AEDs), which may cause rhabdomyolysis. This article summarizes the characteristics, treatment methods and prognosis of patients with rhabdomyolysis that is induced by antiepileptic drugs. Areas covered: This review is based on PubMed, EMBASE and MEDLINE searches of the literature using the keywords "epilepsy", "antiepileptic drugs","status epilepticus","rhabdomyolysis", and "antiepileptic drugs and rhabdomyolysis syndrome" as well as extensive personal clinical experience with various antiepileptic drugs. Potential relationships between antiepileptic drugs and rhabdomyolysis are discussed. Expert opinion: Worldwide, there are approximately 50 million epilepsy patients, most of whom are treated with drugs. Reports have indicated that the majority of antiepileptic drugs on the market can cause rhabdomyolysis. Although rhabdomyolysis induced by antiepileptic drugs is a rare condition with a low incidence, this condition has serious consequences and merits attention from clinicians.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Oral nucleoside/ nucleotide analogues (NAs) are currently the mainstay of treatment for patients with chronic hepatitis B virus (HBV) infection. They are generally safe to use. However, since their approval in the last decade and a half, the literature has reported adverse effects associated with the use of NA in HBV patients. A comprehensive review on the drug safety is lacking. Areas covered: Significant adverse effects associated with NA use in HBV patients including muscle toxicity, peripheral neuropathy, nephrotoxicity and lactic acidosis are discussed. The reported prevalence of each adverse effect, as well as their predictive factors, reversibility and their use in pregnancy and lactating mothers are covered in this review. Novel data regarding reno-protective effect of telbivudine are also discussed. Expert opinion: Use of NA in HBV is generally safe. Uncommon adverse effects can be minimized or detected early if clinicians exercise adequate precautions when using NA for at-risk populations with regular monitoring.
    No preview · Article · Jan 2016 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Chemotherapy-induced nausea and vomiting (CINV) is associated with a significant deterioration in quality of life and is perceived by patients as a major adverse effect of the treatment. The purpose of the review is to determine the safety and efficacy of current antiemetic agents. Areas Covered: Information on antiemetic guideline recommended antiemetics derived from PubMed showed that the first and second generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonists have been safe and effective in the control of acute emesis with a small number of patients experiencing mild headache, diarrhoea, or constipation. Improvement in the prevention of delayed emesis has occurred with the neurokinin (NK)-1 receptor antagonists aprepitant, netupitant, and rolapitant with mild headache, constipation, hiccups, and fatigue the most commonly reported adverse events. Olanzapine, an antipsychotic that blocks multiple neurotransmitters in the central nervous system, appears to be effective in the prevention of nausea and emesis with mild short term sedation the only reported adverse event. Expert Opinion: The current antiemetics that are recommended by the various international antiemetic guidelines are safe and effective in the prevention of chemotherapy-induced nausea and vomiting when used in the recommended doses. Practitioners should consult the antiemetic guidelines for patients receiving chemotherapy.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Osteoporosis is a disease that has spread worldwide and has become a relevant public health problem. Over the last 2 decades, a number of drugs have been licensed for its treatment owing to their efficacy in preventing fragility fractures. The safety profiles of these drugs are well defined with data from extensive programs of pharmacovigilance to support it. Areas covered: In this article we reviewed the long-term safety of Bisphosphonates, Calcium, Vitamin D, Selective Estrogen Receptor Modulators, Teriparatide and Denosumab. We excluded hormone replacement therapy that lost its indication for the treatment of osteoporosis. The license for the treatment of osteoporosis of Calcitonin was recently withdrawn and that of Strontium ranelate was severely limited. For both drugs, we report EMA statements about their safety profile. Expert opinion: The safety profile of most available drugs for the treatment of osteoporosis is well defined and the most serious adverse events are either rare or predictable. Osteoporosis treatment is a favorable choice in patients at moderate-high risk of fracture, while in patients at low risk pharmacological prevention should involve consideration of the balance between the beneficial effects of treatment, the probability of adverse effects and costs.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Empagliflozin is a sodium glucose co-transporter 2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) by enhancing urinary glucose excretion. Empagliflozin is effective at lowering glycosylated hemoglobin and was recently proven superior to placebo for reduction of cardiovascular disease (CVD) risk. As with any new drug, there are safety considerations that inform its potential use in patients with T2DM. Areas Covered: Here, we evaluate the safety of empagliflozin and provide an expert opinion as to its current and future role in the treatment of patients with T2DM. A search of the English language literature was performed using PubMed search terms: "empagliflozin", "sodium glucose cotransporter 2 inhibitors", and "drug safety". Articles and bibliographies relevant to the subject were reviewed and additional references known to the authors were included. Expert Opinion: The evidence for empagliflozin is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated cardiovascular risk reduction support its consideration as a first line medication in addition to metformin for patients with T2DM and CVD. Ongoing trials will continue to address the safety and efficacy of empagliflozin and expand our clinical knowledge of this medication.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Dual antiplatelet therapy with aspirin and an oral ADP P2Y12 receptor antagonist is the standard-of-care for treatment of patients undergoing percutaneous coronary intervention (PCI). However, oral P2Y12 receptor antagonists have several limitations, including inter- and intra-individual response variability, drug-drug interactions, slow onset and offset of action and delayed platelet inhibition in high-risk clinical settings, such as patients with ST-elevation myocardial infarction. Areas covered: Cangrelor is an intravenous, direct-acting, reversible, potent P2Y12 receptor antagonist. It rapidly achieves near complete platelet inhibition and has a very short half-life and a fast offset of action. We conducted a systematic review searching PubMed/MEDLINE for pharmacodynamic/pharmacokinetic studies and clinical trials in which cangrelor was investigated, published from any time up to November 1(st). For clinical trials, those investigating cangrelor in the setting of PCI were considered for discussion. Expert opinion: Cangrelor is approved by drug regulating authorities worldwide as adjunctive antithrombotic therapy for the full spectrum of patients undergoing PCI, not pre-treated with a P2Y12 receptor inhibitor and not with intent to receive a glycoprotein IIb/IIIa inhibitor. Its unique pharmacological properties and its favorable safety and efficacy profile make it an attractive treatment strategy, especially in clinical settings where immediate platelet inhibition is required.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Doxycycline is highly effective, inexpensive with a broad therapeutic spectrum and exceptional bioavailability. However these benefits have been overshadowed by its classification alongside the tetracyclines - class D drugs, contraindicated in pregnancy and in children under 8 years of age. Doxycycline-treatable diseases are emerging as leading causes of undifferentiated febrile illness in Southeast Asia. For example scrub typhus and murine typhus have an unusually severe impact on pregnancy outcomes, and current mortality rates for scrub typhus reach 12-13% in India and Thailand. The emerging evidence for these important doxycycline-treatable diseases prompted us to revisit doxycycline usage in pregnancy and childhood. Areas Covered: A systematic review of the available literature on doxycycline use in pregnant women and children revealed a safety profile of doxycycline that differed significantly from that of tetracycline; no correlation between the use of doxycycline and teratogenic effects during pregnancy or dental staining in children was found. Expert Opinion: The change of the US FDA pregnancy classification scheme to an evidence-based approach will enable adequate evaluation of doxycycline in common tropical illnesses and in vulnerable populations in clinical treatment trials, dosage-optimization pharmacokinetic studies and for the empirical treatment of undifferentiated febrile illnesses, especially in pregnant women and children.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Mammalian target of rapamycin (mTOR) inhibitors (sirolimus and everolimus) are a class of immunosuppressive drugs approved for solid organ transplantation (SOT). By inhibiting the ubiquitous mTOR pathway, they present a peculiar safety profile. The increased incidence of serious adverse events in early studies halted the enthusiasm as a kidney sparing alternative to calcineurin inhibitors (CNI). Areas Covered: Herein we review mTOR inhibitors safety profile for adult organ transplantation, ranging from acute side effects, such as lymphoceles, delayed wound healing, or cytopenias, to long-term ones which increase morbidity and mortality, such as cancer risk and metabolic profile. Infection, proteinuria, and cutaneous safety profiles are also addressed. Expert Opinion: In the authors' opinion, mTOR inhibitors are a safe alternative to standard immunosuppression therapy with CNI and mycophenolate/azathioprine. Mild adverse events can be easily managed with an increased awareness and close monitoring of trough levels. Most serious side effects are dose- and organ-dependent. In kidney and heart transplantation mTOR inhibitors may be safely used as either low-dose de novo or through early-conversion. In the liver, conversion 4 weeks post-transplantation may reduce long-term chronic kidney disease secondary to calcineurin nephropathy, without increasing hepatic artery/portal vein thrombosis.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: The treatment of some early-stage and most locally advanced disease cervical cancer patients consists of concurrent chemoradiation, while almost all with advanced disease require palliative chemotherapy. Areas covered: This review is aimed to analyze the safety issues emerging from trials of chemoradiation for early-stage high-risk disease and locally advanced stages, as well as safety issues of trials of palliative chemotherapy for advanced disease. Safety issues on fertility preservation are also discussed. Expert opinion: Cisplatin chemoradiation produces higher toxicity as compared to radiation alone, yet it is well-tolerated. Further advances would require i) the development of more effective and tolerated combination chemoradiation regimens, ii) demonstration of the efficacy and tolerability of adjuvant chemotherapy after cisplatin chemoradiation, and iii) incorporation of targeted therapies into radiosensitizing regimens. A major problem continues to be the population of patients with advanced disease. The recent incorporation of bevacizumab into chemotherapy regimens represents a step forward; however, toxicity as well as economic issues may impede its wide acceptance worldwide. Preserving fertility in young women with cervical cancer is an issue that must be fully addressed. In this setting, neoadjuvant chemotherapy seems to increase fertlity rate without compromising oncological outcomes.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: The discontinuation rate with phosphodiesterase type 5 inhibitors (PDE5i) remains very high. Recently, a new PDE5ì, avanafil, has become available worldwide. Areas covered. All placebo-controlled randomized clinical trials (RCTs) on the effect of avanafil in patients with ED were reviewed and meta-analyzed. So far, 5 different RCTs on avanafil have been published, including 1379 and 605 patients in active and placebo groups, respectively. Avanafil was up to 3-fold superior to placebo in determining successful sexual intercourse. Although head-to-head comparative studies are still lacking, re-analyses of available data, showed that avanafil had comparable efficacy, but lower incidence of drug-related side effects, compared to first-generation PDE5is. Expert opinion. Avanafil specific and peculiar pharmacological profile, addresses several problems that have been documented with first-generation PDE5is. Avanafil should theoretically guarantee a low dropout incidence by ensuring a natural profile of action and a low incidence of side effects. Longer studies and head-to-heard trials are advisable to clarify these issues.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: Dopamine agonists are highly effective as adjunctive therapy to levodopa in advanced Parkinson's disease. These drugs have rapidly gained popularity as a monotherapy in the early stages of Parkinson's disease for patients less than 65-70 years old since they are about as effective as levodopa but patients demonstrate a lower tendency to develop motor complications. However, dopamine agonists could have peripheral and central side-effects which are often the reason for the discontinuation of the treatment. Areas covered: This article presents an overview of the efficacy and the potential negative effects related to the use of dopamine agonists in the treatment of Parkinson's disease. Expert opinion: Beyond the new generation non ergot dopamine agonists, no strong evidences allow the choice of a specific dopamine agonists for Parkinson 's disease treatment and by now dopamine agonists treatment should be tailored on specific adverse events profile.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Drug safety and gender issues in the treatment with antiepileptic drugs (AEDs) involve considerations to reach an optimal balance between efficacy and adverse effects or toxicity. In this commentary safety issues relevant to AED therapy in women regarding drug interactions and teratogenic effects, and interactions between drugs and endogenous molecules in both genders are highlighted. Gender and safety issues are closely related. Careful clinical and pharmacological considerations are important and need close attention also in future studies and surveillance of existing AEDs and drugs in development.
    Preview · Article · Dec 2015 · Expert Opinion on Drug Safety
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    ABSTRACT: Introduction: The management of sepsis essentially relies on effective resuscitation with fluids and vasopressors, appropriate and adequate antimicrobial therapy, and organ support. Any of these interventions can have beneficial but also harmful effects. Areas covered: We focus on the key hemodynamic signs of sepsis and discuss the potential safety risks associated with the management of each of them, including optimizing arterial pressure, cardiac output and oxygen delivery. We also underline the importance of the timing of interventions. Expert opinion: Patients with septic shock are heterogeneous, making it particularly difficult to provide therapeutic recommendations that are safe and effective for all. A personalized medicine approach should be used with treatment decisions carefully considered and the risks and benefits of each intervention balanced in each individual patient.
    No preview · Article · Dec 2015 · Expert Opinion on Drug Safety