Expert Opinion on Drug Safety Journal Impact Factor & Information

Publisher: Informa Healthcare

Journal description

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

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author cannot archive a post-print version
  • Restrictions
    • 12 months embargo
  • Conditions
    • On author's personal website or institution website
    • Publisher copyright and source must be acknowledged
    • 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: 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: 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: 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: 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; DOI:10.1517/14740338.2015.1093621
  • Seul Min Choi · Byung-Mu Lee
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    ABSTRACT: Introduction: Anabolic androgenic steroids (AASs) have been in use for decades for the treatment of short stature, severe burns, HIV wasting syndrome, osteoporosis, and anemia. However, their lack of selective effects on certain symptoms and unfavorable pharmacokinetic properties has limited their long-term usage in clinics. Areas covered: Selective androgen receptor modulators (SARMs) have some advantages over AASs; they are highly specific for androgen receptors, are orally available, and, most importantly, act as strong receptor agonists in skeletal muscle and bone, and as weak agonists or antagonists in androgen-responsive tissues such as the prostate and sebaceous glands. The exact molecular mechanism, however, has not been fully elucidated. This article includes a toxicological review of major AASs, and a comparative safety analysis of major AASs and SARMs in clinical trials to evaluate the therapeutic potential of SARMs. Expert opinion: Based on the robust tissue selectivity of SARMs over AASs, they are worth considering as a promising therapeutic option for the treatment of various muscle-wasting diseases.
    Expert Opinion on Drug Safety 09/2015; DOI:10.1517/14740338.2015.1094052
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    ABSTRACT: Introduction: Tasimelteon, a novel circadian regulator, is the first product for the treatment of Non-24-hour Sleep-Wake Disorder (Non-24) approved by either the FDA or the European Medicines Agency (EMA). Tasimelteon is a potent and specific melatonin (MT1 and MT2) receptor agonist with 2 - 4 times greater affinity for the MT2 receptor. Methods: Safety was assessed in two controlled and two open-label studies in blind individuals with Non-24 and in two controlled studies of primary insomnia. Periodic assessments included collection of adverse events (AEs), laboratory testing, electrocardiograms (ECGs), vital sign monitoring, physical examinations and assessment for the potential for suicide. One study included additional assessments for endocrine function. Results: A total of 184 blind individuals with Non-24 received tasimelteon nightly with a median exposure > 1 year. In placebo-controlled studies, 387 patients with insomnia and 42 patients with Non-24 received tasimelteon nightly for 4 - 26 weeks. The total patient years exposure for the six studies assessed here is 258.64 patient years. Discontinuations due to AEs were similar across treatment groups. Overall in the clinical studies described here, AEs attributable to tasimelteon treatment were headache, diarrhea, dry mouth, alanine aminotransferase increased, somnolence, dizziness and nightmare/abnormal dreams. There were no clinically significant differences in treatment group with ECGs, vital signs, withdrawal, endocrine function and suicidality assessments. Conclusion: Long-term tasimelteon administration was safe and well-tolerated. This is supported by placebo-controlled data in both Non-24 and insomnia patients.
    Expert Opinion on Drug Safety 09/2015; DOI:10.1517/14740338.2015.1093112
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    ABSTRACT: Introduction: Statins were introduced as lipid-lowering agents with a specific action to decrease plasma cholesterol concentrations and they have led to significant reductions in cardiovascular morbidity and mortality. Since their introduction, they have been found to have highly pleiotropic effects and potential use in many medical conditions well beyond cardiovascular disease alone. With their widespread and increasing use, adverse effects have also become apparent and it is suggested from the interrogation of observational data from large datasets that an early complication of statin use may be acute kidney injury (AKI). Areas covered: This review explores the evidence relating to statins and the risks of AKI. The pathophysiology of AKI is considered and the statins are compared and contrasted. Statins have also been attributed with reno-protective effects and the literature relating to these circumstances are reviewed. Expert opinion: The question of whether statins cause AKI remains unresolved. Evidence suggests that statins may both protect or harm kidneys acutely and that risk varies with the condition and the dose and type of statin used. However, any current adverse data should not deter prescription of statins in patients where there is clear evidence for either primary or secondary prevention of cardiovascular events.
    Expert Opinion on Drug Safety 09/2015; 14(10):1-15. DOI:10.1517/14740338.2015.1085504
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    ABSTRACT: Treatment of chronic hepatitis C virus (HCV) therapy has rapidly changed since the approval of IFN in the 1990s. Early treatment brought about significant and therapy limiting adverse drug events (ADEs) such as anemia. Since the direct-acting antivirals were first approved in 2011 and then advanced in 2013, treatment-related ADEs and therapy discontinuations have rapidly decreased, while sustained virologic response rates have significantly increased. As the market for treating chronic HCV therapy has changed, so too has the ADE profile clinicians may need to manage.
    Expert Opinion on Drug Safety 09/2015; DOI:10.1517/14740338.2015.1088002
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    ABSTRACT: Introduction: Sickle cell anemia (SCA) is a severe, inherited hemoglobin disorder affecting 100,000 persons in the US and millions worldwide. Hydroxyurea, a once daily oral medication, has emerged as the primary disease-modifying therapy for SCA. The accumulated body of evidence over 30 years demonstrates that hydroxyurea is a safe and effective therapy for SCA, but hydroxyurea remains underutilized for a variety of reasons. Areas covered: In this review, we summarize the available evidence regarding the pharmacology, clinical, and laboratory benefits, and safety of hydroxyurea therapy for the treatment of SCA. The purpose of this review is to provide the reader a comprehensive understanding of hydroxyurea and to reinforce the fact that hydroxyurea is a safe and effective medication for the treatment of SCA. Expert opinion: In our opinion, hydroxyurea therapy should be considered standard-of-care for SCA, representing an essential component of patient management. Early initiation and broader use of hydroxyurea will alter the natural history of SCA, so affected children can live longer and healthier lives. In addition, hydroxyurea use should be extended to low-resource settings such as sub-Saharan Africa, where the burden of SCA and the need for hydroxyurea is arguably the greatest.
    Expert Opinion on Drug Safety 09/2015; DOI:10.1517/14740338.2015.1088827
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    ABSTRACT: Introduction: Epidemiological evidence suggests an increased incidence of cancer in obese, prediabetic, and diabetic patients and a reduced risk of cancer incidence and mortality in diabetic patients on metformin compared with other antidiabetic drugs. In vitro studies support the efficacy of metformin in cancer therapy and prevention. Although metformin seems to be promising as a cancer chemopreventive or therapeutic drug, the principal consideration is whether metformin will be effective in cancer clinical trials for nondiabetic subjects or only in diabetics or subjects with insulin resistance. Safety of metformin is even more important in treating nondiabetic patients. Areas covered: The present review focuses on epidemiological data and clinical trials testing the efficacy of metformin on cancer, the safety in nondiabetic patients and the future development of this promising drug. Expert opinion: Meta-analyses of epidemiological in which metformin treatment has been used for diabetic patients show a positive trend for benefit; nevertheless, clinical data outcomes are preliminary and the results of ongoing trials are awaited. The different types of cancer, heterogeneity of populations and presence of comorbidity make it difficult to determine the benefits of metformin in cancer prevention and treatment.
    Expert Opinion on Drug Safety 09/2015; 14(10):1-13. DOI:10.1517/14740338.2015.1084289
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    ABSTRACT: Introduction: Ibrutinib , a targeted inhibitor of B-cell receptor signaling, achieved impressive clinical results for patients with chronic lymphocytic leukemia (CLL). These results allowed the approval of ibrutinib for the treatment of patients with CLL who have received at least one prior therapy and those with a 17p deletion regardless of line of therapy. Areas covered: Comprehensive data from either Phase I-II or randomized Phase III studies are analyzed in this article. In addition, we reviewed data on the prevalence and the clinical management of some peculiar toxicities ibrutinib related such as lymphocytosis, major bleeding and atrial fibrillation. Expert opinion: Ibrutinib has radically changed the scenery of relapsed/refractory CLL treatment and established an important paradigm in the molecularly targeted approach of this disease. Discontinuation of ibrutinib is rarely due to adverse events related to the drug. Patients who discontinue treatment represent a challenge to the physicians because treatment options are very limited.
    Expert Opinion on Drug Safety 09/2015; 14(10):1-9. DOI:10.1517/14740338.2015.1084286
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    ABSTRACT: Introduction: Cyclosporine-A and tacrolimus are the cornerstones in modern immunosuppression after organ transplantation. They are potent inhibitors of calcineurin, that is, so-called calcineurin-inhibitors (CNIs). However, because these drugs have narrow therapeutic windows, they are associated with many side-effects, with some being dose related. Areas covered: The most frequent side-effect of CNIs is nephrotoxicity, which in the long term can contribute, to allograft deterioration. Other frequent side-effects include metabolic disorders (new onset of diabetes, dyslipidemia), neurotoxicity, or promoting of de novo cancers. Expert opinion: In kidney transplantation, many strategies have been developed to minimize nephrotoxicity while maintaining efficacy of immunosuppression: for example, the minimization of CNI in addition to either full-dose mycophenolic acid or low doses of m-TOR inhibitors, mainly everolimus (EVR). Attempts made to eliminate CNIs by replacing them with m-TOR inhibitors have been unsuccessful because of occurrence of de novo donor-specific alloantibodies in a substantial number of patients, associated with antibody-mediated rejection. Conversely, CNI-avoidance by replacing them by Belatacept is feasible with very good renal function in the long term despite a significant increase in acute cellular rejections within the first-year posttransplantation. Other side-effects of CNIs, such as neurologic disorders, diabetes, dyslipidemia, viral infections, and cancer, seem to be less frequent in low-dose or CNI-free immunosuppressive regimens. Thus, although CNIs remain the major immunosuppressive treatment, their dosage should be minimized by using them with either full-dose MPA or reduced-dose EVR.
    Expert Opinion on Drug Safety 09/2015; 14(10):1-16. DOI:10.1517/14740338.2015.1083974
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    ABSTRACT: Introduction: The introduction of direct-acting antiviral (DAA) agents has revolutionized the treatment of hepatitis C virus (HCV) chronic infection. Non-structural 3 protease inhibitors are currently the most numerous class of DAAs on the market. Areas covered: This review mainly focuses on the tolerability and safety profile of asunaprevir (ASV)-containing DAA regimens. ASV is a second-wave protease inhibitor currently in Phase III clinical development in most countries and already available in Japan. Expert opinion: ASV shows potent antiviral effect and clinical efficacy on HCV genotypes 1 and 4. The all-oral combination daclatasvir/ASV reached high eradication rates in HCV genotype 1b and 4 infection, and a lower efficacy in genotype 1a infection. ASV presents a low potential for drug-drug interaction and a good tolerability as part of multiple, including all-oral, regimens. ASV is associated with a transient and usually mild increase in aminotransferase levels in a low percentage of cases. Due to the impaired pharmacokinetic profile observed in advanced liver disease, ASV use in patients with moderate or severe hepatic impairment is not allowed. In conclusion, ASV represents a powerful weapon against HCV infection and has to be considered an optimal option as a component of genotype tailored interferon-free combinations.
    Expert Opinion on Drug Safety 09/2015; 14(10):1-16. DOI:10.1517/14740338.2015.1084287
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    ABSTRACT: Introduction: Seizures in pregnancy are particularly challenging, as their management requires careful consideration of not only the etiology of the seizure, but also the physiologic changes of pregnancy as well as potential adverse effects on the developing embryo or fetus. Newer antiepileptic drugs (AEDs) have increasingly shown promising results of lower rate of teratogenesis, as well as better seizure control during pregnancy. Areas covered: We performed a review of the scientific literature of seizures in pregnancy including status epilepticus as well as eclampsia, with a focus on safety of currently used AEDs. This covers the different generations of antiepileptic medications, their interactions and seizure recurrence preventative measures. In addition, we summarized our personal approach to the care for these women. Expert opinion: In summary, morbidity associated with seizure in pregnancy is decreasing as treatments and supportive therapies have improved. The understanding of teratogenesis as well as novel targeted therapeutics will allow women on AEDs during their pregnancy, to receive the safest drug for their developing fetus as well as themselves.
    Expert Opinion on Drug Safety 09/2015; 14(10):1-12. DOI:10.1517/14740338.2015.1085503
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    ABSTRACT: Introduction: In patients with acromegaly, somatostatin analogs (SSA) represent the first choice medical treatment. The long-acting SSA have been found to be effective in controlling growth hormone and IGF-I levels in a high percentage of patients, resulting in an improvement in the quality of life; moreover, these peptide analogs have a proven safety record and are generally well tolerated. Areas covered: The most commonly reported adverse events include injection-site discomfort and erythema, gastrointestinal (GI) disturbances such as diarrhea, abdominal pain, nausea and vomiting, biliary sludge or gallstones, and abnormal glucose metabolism. Most SSA-related adverse events are transient and of mild-to-moderate intensity, and the prevalence of such effects markedly and progressively decreases during treatment, so that treatment discontinuations due to adverse events are rare and commonly related to GI disturbances. Cholelithiasis represents the most serious complication of SSA, but is generally asymptomatic, and has been reported in 3 - 56% of patients. Whereas the effect of SSA on glucose metabolism is still controversial, several pieces of evidence have confirmed a modest and transient negative impact on glucose homeostasis. Also the novel SSA pasireotide has shown a safety profile as expected for a SSA, except for the degree of hyperglycemia. Expert opinion: On the basis of these findings, a close and careful monitoring of gallbladder ultrasound and glucose levels is recommended in patients receiving SSA for medical treatment of acromegaly.
    Expert Opinion on Drug Safety 08/2015; 14(8):1213-1226. DOI:10.1517/14740338.2015.1059817
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    ABSTRACT: Introduction: Primary biliary cirrhosis (PBC) is a chronic, cholestatic liver disease characterized histologically by lymphocytic cholangitis and intralobular bile duct destruction. It is a progressive disorder associated with increased mortality and decreased quality of life related to hepatic fibrosis, troublesome symptoms such as fatigue and pruritus, and ultimately endstage cirrhosis. PBC affects adults around the world, and therefore effective treatment of PBC and its associated symptoms constitute significant issues for patients and providers as well as on a public health level. The only approved pharmacotherapy for PBC to date is ursodeoxycholic acid (UDCA), a choleretic, hydrophilic bile acid which has been in clinical use for decades. UDCA is effective in a majority of patients with PBC, but nearly a third of patients are UDCA non-responders. Non-response to UDCA is associated with an increased risk of death or need for liver transplantation (LT). Whereas LT is an effective treatment, it engenders substantial cost and a risk of PBC recurrence, among other complications. Patients who are non-responders to UDCA or have highly symptomatic disease (e.g., intractable pruritus) are thus in critical need of novel therapeutic approaches, which are both safe and effective. Areas covered: In this review, we provide a synopsis regarding the safety and benefits of established and emerging pharmacotherapies for PBC and present viewpoints on how they may evolve over the next several years. Expert opinion: It is our belief that the pharmacoscope of PBC, as with other cholestatic liver diseases, is likely to see important advancements in the near future.
    Expert Opinion on Drug Safety 07/2015; 14(9):1-10. DOI:10.1517/14740338.2015.1073260