Expert Opinion on Drug Safety Journal Impact Factor & Information

Publisher: Informa Healthcare

Current impact factor: 2.91

Impact Factor Rankings

2015 Impact Factor Available summer 2016
2014 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

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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    • 12 months embargo
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    • On author's personal website or institution website
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    • Non-commercial
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    • 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

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: As a chronic disease, allergic rhinitis (AR) requires regular use of allergy medications for the effective management of symptoms. It is therefore imperative that AR treatments not only provide adequate symptom control, but are also well-tolerated. Area covered: MP29-02 (Dymista, Meda, Solna, Sweden) is the first new class of AR medication (WHO ATC R01AD58) since the introduction of intranasal corticosteroids (INS) almost 50 years ago. It is a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) delivered in a single spray. Here we review all the safety information relevant to MP29-02, from the initial Phase I bioavailability and disposition data, to the Phase III 14-day and 52-week data, to Phase IV safety data collected during MP29-02 use in routine clinical practice. Expert Opinion: MP29-02 is the first real therapeutic advance in AR since the introduction of INS and has the potential to change the way this disease is managed, simplifying AR treatment regimens to a single puff in each nostril twice a day. Patients will benefit from superior symptom relief MP29-02 compared to INS with the added assurance that the safety of MP29-02 has been confirmed in the short- and long-term as well as in real life.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1122755
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    ABSTRACT: Introduction All medical treatments for endometriosis are equally effective in relieving pain. However, all of them alleviate pain symptoms for as long as they are used, but pain always relapses when medication is discontinued. Therefore, medications need to be used in the long term. Areas covered. Formulations of estro-progestins that contain less than 50 µg of estrogen are associated with a low risk of venous thrombosis, myocardial infarction and stroke. When considering the neoplastic effects, data suggest that the overall risk of invasive cancer by age 60 is not increased in previous users of hormonal contraceptives. The use of progestins for contraception has never been associated with an increased risk of breast cancer, venous thromboembolism or bone fractures. Although more data on long-term therapy with progestins are needed, treatment of endometriosis with progestins may be feasible in women with metabolic or cardiovascular contraindications to estroprogestin. The other medications for the treatment of pain associated with endometriosis are less appropriate for long term administration because of side effects (danazol and GnRH analogues), costs (aromatase inhibitors and GnRH agonists) or necessity of complex regimens of associations (GnRH agonists and add back therapy or aromatase inhibitors plus progestins). Expert opinion. Progestins and estroprogestins are safe drugs to use in the long term. Adherence to these medications may be high because, being a contraceptive, they are perceived less as a medication for the treatment of a disease. The annual cost of therapy compares favorably with other available medications. Progestins and estroprogestins represent the first-line medications for the treatment of endometriosis associated pain.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1121991
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    ABSTRACT: Introduction: The direct acting antiviral daclatasvir is an NS5A replication inhibitor active against the entire range of hepatitis C virus genotypes. It is a key step in establishing the goal of an all-oral, ribavirin-free, pan-genotypic regimen against hepatitis C. Areas covered: We review current literature including published abstracts and manuscripts. Evidence was obtained through PubMed/Medline search using listed keywords and through review of published abstracts. Expert opinion: Daclatasvir introduces a degree of pangenotypic potency currently lacking in other NS5A agents. Emerging literature suggests that daclatasvir in combination with other DAAs will represent a promising option in this difficult to treat populations including posttransplant, genotype 3 and HIV patients.
    Expert Opinion on Drug Safety 11/2015; 14(11):1787-1797. DOI:10.1517/14740338.2015.1100603
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    ABSTRACT: Introduction: Rational selection of a second-generation H1-antihistamine requires efficacy and safety considerations, particularly regarding central nervous system (CNS) effects (cognitive and psychomotor function), potential for driving impairment, minimal sedative effects and a lack of interactions. This review evaluates the key safety features of the non-sedating antihistamine, bilastine, during driving and in preventing road traffic accidents. Areas covered: Among the second-generation H1-antihistamines, sedative effects which can affect cognitive and psychomotor performance, and possibly driving ability, may not be similar. Bilastine is absorbed rapidly, undergoes no hepatic metabolism or cytochrome P450 interaction (minimal drug-drug interaction potential), and is a substrate for P-glycoprotein (limiting CNS entry). Positron emission tomography showed that, compared with other second-generation H1-antihistamines, bilastine has the lowest cerebral histamine H1-receptor occupancy. Bilastine 20 mg once daily (therapeutic dose) is non-sedating, does not enhance the effects of alcohol or CNS sedatives, does not impair driving performance and has at least similar efficacy as other second-generation H1-antihistamines in the treatment of allergic rhinoconjunctivitis and urticaria. Expert opinion: Current evidence shows that bilastine has an optimal benefit-to-risk ratio, meeting all conditions for contributing to safety in drivers who need antihistamines, and hence for being considered as an antihistamine of choice for drivers.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1112786
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    ABSTRACT: Introduction: Epilepsy is a common disease that is mostly treated with antiepileptic drugs (AEDs). However, the sexual dysfunction (SD) side effects related to the use of AEDs have not received sufficient attention. Areas covered: The purpose of this review is to examine the current evidence on SD-related side effects of AEDs. The incidence, clinical features and major types of SD are summarized. Furthermore, various AEDs that may cause SDs are addressed in detail. Finally, we briefly summarize the treatments for SD related to AEDs. Expert opinion: SD related to AEDs is common. Symptoms include erectile dysfunction (ED), hyposexuality, hypersexuality and ejaculatory dysfunction. Traditional AEDs such as valproate and enzyme-inducing AEDs (EIAEDs) may produce high incidences of decreased libido. Recently, sexual function changes related to new AEDs have been reported. Topiramate, pregabalin and gabapentin may cause SD, whereas oxcarbazepine, lamotrigine and levetiracetam may improve sexual function. Although the treatment for SD related to AEDs remains unclear, switching to another AED may be an option. Further studies are necessary to better understand and treat SD related to AEDs.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1112376
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    ABSTRACT: Introduction: Despite being an overall safe drug, several long-term adverse effects are associated with proton pump inhibitors. The link between proton pump inhibitor use and gastric neuroendocrine tumours, gastric adenocarcinomas and Barrett's esophagus progression gastric cancers has been investigated due to proton pump inhibitor induced hypergastrinemia. Areas Covered: The pathophysiological mechanisms underlying proton pump inhibitor exposure and gastric neuroendocrine tumors, gastric adenocarcinomas and Barrett's esophagus progression are discussed. The quality of randomized control studies, cohort studies and case reports investigating the link between gastric cancers and proton pump inhibitors are examined. Recommendations for clinicians are provided. Expert Opinion: PPIs cause a hypergastrinemic state, increasing enterochromaffin like cell dysplasia and risk of gastric neuroendocrine tumor development, increasing gastritis severity in the context of Helicobacter pylori infection, and progression of carcinogenesis in a certain predisposed subset of Barrett's esophagus patients. There are case reports of proton pump inhibitor induced gastric neuroendocrine tumours and adenocarcinomas as consequences of these effects. In pernicious anemia and chronic gastritis, clinicians should be aware of potential increased risk of gastric neuroendocrine tumour development with chronic proton pump inhibitor use in these patients. Eradication status of Helicobacter pylori prior to commencing long term proton pump inhibitor therapy should be established to reduce the risk of severe atrophic gastritis and development of gastric dysplasia.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1118050
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    ABSTRACT: Introduction: The incidence of Inflammatory Bowel Diseases (IBD) is rising and overall epidemiology is changing. Goals of IBD therapy are also fast changing to reflect the concept of mucosal healing. IBD management is increasingly revolving around questions of ideal positioning of biologic therapies. Areas covered: This paper covers important concepts regarding two classes of biologic medications approved for treatment of IBD in the United States - anti-TNF-α agents and lymphocyte-homing antagonists. Topics covered include drug mechanism of action, pharmacokinetic considerations for the clinician including therapeutic drug monitoring, summary of current evidence of drug efficacy in IBD focusing on randomized, controlled trial data. Additionally, nuanced discussion of medication side-effects and adverse reactions is presented. Expert opinion: Paradigms of treatment goals in IBD are changing with increasing focus on mucosal healing. Concomitantly, our understanding of important factors that impact drug pharmacokinetic/pharmacodynamics relationships with biologic agents has increased which will help eventually develop personalized algorithms to optimize the efficacy of these agents. Though direct head-to-head comparisons between these agents are lacking, biologic agents can be considered the safest and most effective therapies introduced for IBD.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2015.1108961
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    ABSTRACT: Introduction: Acne is a common skin condition of the pilosebaceous units that affects the young and old, ranges from moderate to severe, and can be treated with an array of options. Topical retinoids are the initial treatment for acne due to their ability to treat comedones, the starting point of acne. Areas covered: Tazarotene is a topical retinoid available as a cream, gel, and foam. Tazarotene 0.1% foam was FDA approved in 2012 for the treatment of acne in patients ages 12 and over and is the first foam topical retinoid on the market. Phase I and III trials support the efficacy and safety of tazarotene foam for acne. Expert Opinion: The foam vehicles may increase compliance and satisfaction in some patients, and since retinoids are commonly first line acne treatments, this novel topical retinoid foam may be a useful option for some acne patients.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1117605
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    ABSTRACT: Introduction: TNF-α inhibitors have demonstrated efficacy both as monotherapy and in combination with disease-modifying antirheumatic drugs (DMARDs) in the treatment of chronic inflammatory immune-mediated diseases such as rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriasis and/or psoriatic arthritis, and may be administered off-label to treat disseminated granuloma annulare systemic lupus erythematosus and systemic sclerosis. There are several TNF-α inhibitors available for clinical use including infliximab, adalimumab, golimumab, certolizumab pegol and etanercept. Areas covered: infliximab and adalimumab can induce the development of anti-infliximab (anti-IFX) and anti-adalimumab (anti-ADA) monoclonal antibodies (mAbs). In this review, we discuss the impact of anti-IFX and anti-ADA mAbs upon efficacy and safety of these biological agents. Expert opinion: IgG/IgE neutralizing antibodies against infliximab and adalimumab decrease the possibility of achieving a minimal disease activity state or clinical remission, decrease drug survival, increase the need for doctors to prescribe a higher drug dosage and, finally, favor the occurrence of adverse events. Concomitant administration of DMARDs such as methotrexate or leflunomide prevents the development of neutralizing Abs against infliximab and adalimumab.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2016.1112375
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    ABSTRACT: Introduction: Ingenol mebutate is a topical therapeutic agent for the treatment of actinic keratosis (AK). It has a novel mode of action and has shown comparable efficacy to other topical field therapies. This article summarizes and provides perspective on the safety profile of ingenol mebutate from clinical studies of this agent. Areas covered: The unique mechanism of action of ingenol mebutate, the basis for a rapid clinical effect, is outlined. Safety and tolerability data, including mean composite local skin response (LSR) scores, type of LSR, and adverse events from a range of clinical studies both in healthy volunteers and patients with AK, are reviewed. The safety profile of ingenol mebutate is then compared with other agents used to treat AK lesions. Expert opinion: Ingenol mebutate has a dosing period of 2 - 3 days, which is short compared with other field therapies, and there is no evidence of systemic absorption. The fact that most of the LSRs observed are mild to moderate in intensity and transient, with a majority resolved within 2 weeks, makes for a favorable safety profile. Ingenol mebutate enhances the armamentarium available to the dermatologist for the treatment of AK.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2015.1108962
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    ABSTRACT: Background: We performed a meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with S-1-based regimens. Patients and methods: Randomized phase II and III trials of patients with solid tumors on S-1; describing events of all-grade and high-grade stomatitis and diarrhea constituted the eligible studies. Results: After exclusion of ineligible studies, a total of 26 clinical trials were considered eligible for the meta-analysis. The odds ratio (OR) of all-grade and high-grade stomatitis for S-1 vs. non-fluoropyrimidine controls was 4.39 [95% CI: 1.05, 18.37; p = 0.04] and 5.64 [95% CI: 1.46, 21.77; p = 0.01], respectively; while the OR of all-grade and high-grade stomatitis for S-1 vs. infusional 5-fluorouracil (5-FU) control was -1.01 [95% CI: 0.22, 4.63; p = 0.99] and 0.32 [95% CI: 0.20, 0.49; p < 0.00001], respectively. The OR of all-grade and high-grade diarrhea for S-1 vs. non-fluoropyrimidine controls was 2.48 [95% CI: 2.12, 2.90; p < 0.00001] and 1.95 [95% CI: 1.29, 2.96; p = 0.002], respectively; while the OR of all-grade and high-grade diarrhea for S-1 vs. infusional 5-FU control was -1.03 [95% CI: 0.87, 1.22; p = 0.76] and 2.52 [95% CI: 1.80, 3.52; p < 0.00001], respectively. Conclusions: Compared to non-fluoropyrimidine control, patients treated with S-1-based regimens have an increased risk of all-grade and high-grade stomatitis and diarrhea; while on the other hand, patients treated with infusional 5-FU have a greater risk of high-grade stomatitis and diarrhea compared to patients treated with S-1-based regimens.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2016.1105959
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    ABSTRACT: Introduction: Inhibitors of sodium-glucose cotransporters type 2 (SGLT2) offer a new opportunity for the management of type 2 diabetes mellitus. These agents reduce hyperglycemia by decreasing the renal glucose threshold and thereby increasing urinary glucose excretion. Subsequent reduction of glucotoxicity improves beta-cell sensitivity to glucose and tissue insulin sensitivity. Areas covered: This article analyzes the efficacy and safety data of canagliflozin, dapagliflozin and empagliflozin in randomized controlled trials of 24 - 104 weeks duration, compared with placebo or an active comparator, in patients treated with diet/exercise, metformin, dual oral therapy or insulin. Expert opinion: SGLT2 inhibitors significantly and consistently reduce glycated hemoglobin, with a minimal risk of hypoglycemia. The improvement of glucose control is similar or slightly better compared with metformin, sulfonylureas or sitagliptin, with the add-on value of significant reductions in body weight and blood pressure. However, caution is recommended in fragile elderly patients and patients with chronic kidney disease. An increased risk of genital mycotic infections is observed, but urinary tract infections are rare. Concern about an unexpected risk of euglycemic ketoacidosis has been recently reported. A possible renal protection deserves further attention. A remarkable reduction in cardiovascular mortality was reported in EMPA-REG OUTCOME with empagliflozin.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1100167
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    ABSTRACT: Background: The incidence, course and risk factors associated with renal impairment (RI) in patients treated with triple therapy (TT) with pegylated interferon, ribavirin and telaprevir/boceprevir (PR/TVR/BOC) vs. dual therapy (DT) with PR were analyzed in this study. The association between RI and the decline of hemoglobin (Hb) was also examined. Methods: Retrospective analysis included 110 patients with genotype 1b chronic HCV infection, aged 18 - 80 years, who underwent TT (48TVR/14BOC) or DT (48 patients). The estimated glomerular filtration rate (eGFR), serum creatinine concentration (SCr) and Hb were measured at baseline, at weeks 4, 12, 24, 48 of treatment, and post-treatment week 24. Results: RI occurred in 9/62 (14.5%) patients who underwent TT, eight of whom were treated with TVR, one with BOC, and none treated with DT. The risk factors associated with RI were the following: TT (p = 0.0078), usage of nephrotoxic drugs (p = 0.0288), and older age (p < 0.0001). RI was reversible. A drop of Hb was associated with RI, older age and TT. Conclusions: RI is not a rare but a reversible complication of TT. It is necessary to monitor SCr and eGFR, especially in patients with a potential risk factor of RI occurrence. The Hb drop is more severe in patients with RI than in those without it.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1102882
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    ABSTRACT: Introduction: Beta blockers are one of the cornerstones for treatment of Heart Failure with Reduced Ejection fraction (HFRef), yet their use is often limited by adverse effects, either perceived or real. We performed a review of available data using utilizing beta blocker, heart failure, reduced ejection fraction and safety as key words. Areas covered: Several well designed, large scale randomized clinical trials including CIBS-II (bisoprolol), MERIT-HF (metoprolol succinate), and Copernicus (carvedilol) among others, have been conducted in patients with HFRef and demonstrated an improvement in cardiac mortality and morbidity. Despite the preponderance of data supporting the use of beta blockers for patients HFRef, these medications remain underutilized and/or are often prescribed at lower than recommended dosages. Some of the reluctance to embrace beta blockade may be attributed to concern on the part of both the patient and prescriber about the non-cardiac adverse effects of this class of drugs. We have reviewed several recent reviews and meta-analyses of trials of beta blocker in heart failure which have conclusively demonstrated their tolerability in the populations studied. Expert opinion: In the final section of this paper we provide our opinions regarding initiating and optimizing beta blocker therapy for patients with HFRef.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1102225
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    ABSTRACT: Introduction: Lenvatinib is an oral multitargeted tyrosine kinase inhibitor of VEGFR1,2,3,4, FGFR1,2,3,4, PDGFR-α as well as RET and KIT signaling network. Its activity against radioiodine-resistant differentiated thyroid cancer (DTC) has been recently demonstrated. Patients, who were given lenvatinib, showed significantly longer median progression free survival than placebo group, 18.3 vs 3.6 months, respectively. This review is focused on lenvatinib safety profile in patients treated due to DTC and medullary thyroid carcinoma. Among the most frequent lenvatinib-related adverse events (AEs) were hypertension, proteinuria, diarrhea, appetite decrease, weight loss, nausea and stomatitis. Although a lot of them were manageable, in 35-68% of patients dose reduction was required. Nevertheless, only 15% of subjects withdrew the drug due to its toxicity.Areas covered: published results of clinical trials phase II and III investigating both safety and efficacy of lenvatinib in thyroid cancer.Expert opinion: Lenvatinib shows acceptable safety profile in patients with thyroid carcinoma. Treatment-related side effects are usually manageable by dose modifications or by concomitant non-pharmacological and pharmacological treatment. However, the early recognition of any potential drug toxicity is crucial to avoid serious complications as well as to keep a patient on drug as long as the treatment is beneficial.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1102883
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    ABSTRACT: Background: We conducted a meta-analysis to assess the overall risk of cardiac toxicity associated with trastuzumab treatment in elderly breast cancer patients. Methods: We searched databases from PubMed, EMBASE and Cochrane Central Registry of Controlled Trials to identify relevant studies. Statistical analyses were conducted to calculate the incidence rate, overall hazard ratio (HR) and 95% CIs using a fixed effects model. Results: A total of 116,342 and 360 elderly patients from five cohort studies and two randomized clinical trials (RCTs) were included for analysis. The pooled incidences of symptomatic congestive heart failure (CHF) and CHF/HF/CM were 6.4% (95% CI 4.1% - 9.4) and 16.4% (95% CI 16.19% - 16.61) in patients with median age of 67.5 years from two RCTs and in patients with median age of 67.5 (60 - 75), 71 (66 - 80+), 74.5 (65 - 89), 75 (66 - 81+) and 79.5 (60 - 99) from five cohort studies, respectively. Trastuzumab was significantly correlated with an increased risk of defined cardiac toxicities in five cohort studies (HR = 1.89, 95% CI 1.72 - 2.07, p < 0.00001) and two RCTs (HR = 3.00, 95% CI 1.71, 5.26, p < 0.00001). Sub-group analysis showed that the anthracycline-based chemotherapy increased the risk of CHF/HF and CM in patients among five cohort studies (HR = 2.16, 95% CI: 1.8 - 1.87, p < 0.00001). Conclusion: Trastuzumab is likely associated with an increased risk of cardiac toxicity in elderly patients with HER-2-positive breast cancer. Carefully monitoring cardiac function in elderly patients receiving trastuzumab, particularly with concurrent use of anthracycline, is warranted.
    Expert Opinion on Drug Safety 10/2015; 14(11):1-11. DOI:10.1517/14740338.2015.1089231
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    ABSTRACT: Introduction: Advent of new technologies in mobile devices and software applications is leading to an evolving change in the extent, geographies and modes for use of internet. Today, it is used not only for information gathering but for sharing of experiences, opinions and suggestions. Web-Recognizing Adverse Drug Reactions (RADR) is a groundbreaking European Union (EU) Innovative Medicines Innovation funded 3-year initiative to recommend policies, frameworks, tools and methodologies by leveraging these new developments to get new insights in drug safety. Areas covered: Data were gathered from prior surveys, previous initiatives and a review of relevant literature was done. New technologies provide an opportunity in the way safety information is collected, helping generate new knowledge for safety profile of drugs as well as unique insights into the evolving pharmacovigilance system in general. It is critical that these capabilities are harnessed in a way that is ethical, compliant with regulations, respecting data privacy and used responsibly. At the same time, the process for managing and interpreting this new information must be efficient and effective for sustenance, thoughtful use of resources and valuable return of knowledge. These approaches should complement the ongoing progress toward personalized medicine. Expert opinion: This Web-RADR initiative should provide some directions on 'what and how' to use social media to further proactive pharmacovigilance and protection of public health. It is expected to also show how a multipronged expert consortium group comprising regulators, industry and academia can leverage new developments in technology and society to bring innovation in process, operations, organization and scientific approaches across its boundaries and beyond the normal realms of individual research units. These new approaches should bring insights faster, earlier, specific, actionable and moving toward the target of AE prevention. The possibilities of a blended targeted pharmacovigilance (PV) approach where boundaries between stakeholders blur and cultures mix point to very different future for better, healthier and longer lives.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1096342
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    ABSTRACT: Objective: The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0 - 17 years in Ghana. Methods: Paediatric reports submitted by the Ghana National Centre for Pharmacovigilance to the World Health Organisation (WHO) Global ADR database, VigiBase up to December 2012 were extracted. The data were analysed for number of reports per year, types of reporters and suspected ADRs and drugs. Results: A total of 343 reports for children were received during the period. The drug classes most frequently reported were vaccines (115, 31%), antimalarials (106, 28%) and antibiotics (57, 15%). Of the top 20 individual drugs, 19 were anti-infectives. The most frequently reported ADRs were injection site infection, fever and rash. There were 23 deaths reported, and antimalarials were implicated in 12 cases. Conclusions: Vaccines, antimalarials and antibiotics are the leading medicines reported to cause ADRs in Ghanaian children. There was a high mortality rate, with many of the deaths due to causes explained in the individual case safety reports.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1096927
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    ABSTRACT: Introduction: Statins are evidence-based drugs to prevent cardiovascular (CV) disease. However, their benefits have been disputed by a statin-related increased risk of new onset diabetes (NOD) in randomized controlled trials and meta-analyses. Areas covered: This review provides an update based on recent outstanding evidence on the statin effect on the risk of diabetes. It also describes mechanisms potentially explaining adverse effects of statins on glucose homeostasis. PubMed was searched for original articles and reviews published from January 2010 (inclusive) to May 2015 (inclusive), which include the Search terms statins, diabetes, glucose, and insulin. NOD risk seems to be more relevant with high-intensity rather than with low-intensity statin treatment. Also, this risk is particularly increased in patients at risk for the development of diabetes. It appears that statins adversely affect glucose homeostasis in parallel with their 3-hydroxy-3-methylglutaryl-coenzyme A inhibition capacity. It was suggested that lipophilic statins are more diabetogenic than the hydrophilic ones. Mechanisms explaining statin diabetogeneicity include impaired insulin secretion by pancreatic β cells together with increased insulin resistance of various tissues. Expert opinion: The CV outcome benefits from statin use outweigh the diabetes menace. However, patients at risk for the development of diabetes should be prescribed statins with caution.
    Expert Opinion on Drug Safety 10/2015; DOI:10.1517/14740338.2015.1096343
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    ABSTRACT: Introduction: Poorly absorbable quaternary ammonium-inhaled muscarinic antagonists both as the short-acting ipratropium and as long-acting (12 - 24 h) agents (tiotropium, glycopyrronium, aclidinium and umeclidinium) have all demonstrated statistically and clinically significant efficacy in chronic obstructive pulmonary disease compared with placebo. However, controversy has arisen concerning the safety of this class of agents principally regarding their association with both fatal and nonfatal cardiovascular toxicity. Areas covered: The safety of both ipratropium and the long-acting muscarinic antagonists is reviewed with a major emphasis on potential cardiovascular toxicity, based on published clinical trials data and results of analyses of pooled data, meta-analyses, and observational studies. Since glycopyrronium, aclidinium, and umeclidinium have become available only relatively recently, more emphasis will be placed on the more extensive literature concerning the safety of the older anticholinergic compounds, the short-acting ipratropium, and the long-acting tiotropium in its dry powder formulation, as well as its newer soft mist inhaler delivery device. Expert opinion: Pooled analyses and meta-analyses of randomized controlled trials (RCTs) of tiotropium in both its dry powder and soft mist formulations, as well as some observational studies, have implicated this agent as increasing the risk of nonfatal and fatal cardiovascular events. However, the most robust evidence based on large-scale randomized controlled trials (RCTs) of relatively long duration specifically designed to evaluate the cardiovascular safety of tiotropium have not confirmed these safety concerns. Because of the relatively limited amount of safety data for the newer long-acting muscarinic antagonists compared to the far more extensive experience with tiotropium, it will be important to accumulate additional safety information from post-marketing pharmacovigilance for these newer agents.
    Expert Opinion on Drug Safety 09/2015; 14(11):1-14. DOI:10.1517/14740338.2015.1093621