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Journal Cover Drug Safety
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   ISSN (Print) 0114-5916 - ISSN (Online) 1179-1942
   Published by Adis Homepage  [20 journals]
  • Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA
           Regarding Thromboembolic Adverse Events and JAK Inhibitors
    • Abstract: Introduction The Janus kinase (JAK) inhibitor baricitinib is approved in Europe and Japan for the treatment of rheumatoid arthritis. In April 2017, the US FDA expressed concern about thromboembolic events (deep venous thrombosis [DVT] and pulmonary embolism [PE]) observed in placebo-controlled clinical trials of baricitinib. The European and Japanese labels for baricitinib were recently updated to include a precaution related to potential thromboembolic events in patients at risk. Given that the FDA-approved drugs tofacitinib and ruxolitinib are in the same class, we conducted a safety review of the FDA’s Adverse Event Reporting System (FAERS) to assess postmarketing reporting rates for related thromboembolic risks. Methods Adverse event (AE) data for tofacitinib, tofacitinib extended-release (XR), and ruxolitinib were obtained from the FAERS. Reporting odds ratios (RORs) and the R package ‘PhViD’ to estimate the empirical Bayesian geometric mean (EBGM) were used to detect AEs with higher-than-expected reporting rates within the FAERS. Results We did not find evidence in the FAERS for elevated reporting rates for DVT and PE across the three JAK inhibitors we analyzed. However, multiple drug–AE combinations relating to thromboembolic events had both RORs and EBGM values above 1, indicating a trend toward higher-than-expected reporting rates. For pulmonary thrombosis, the ROR values for ruxolitinib, tofacitinib, and tofacitinib XR were 1.46 (95% confidence interval [CI] 0.76–2.80), 2.46 (1.55–3.91), and 2.48 (0.80–7.71), respectively, while the EBGM values were 1.25 (0.70), 2.46 (1.64), and 1.56 (0.57), respectively. Ruxolitinib had ROR values of 4.08 (2.25–7.38) and 1.22 (0.97–1.53) for portal vein thrombosis and thrombosis, respectively. The EBGM values for the same drug–AE combinations were 3.04 (1.79) and 1.16 (0.96). Conclusions Our safety review of postmarketing FAERS reports associated with three FDA-approved JAK inhibitors did not find elevated reporting rates for DVT and PE specifically. However, the FAERS data indicated that pulmonary thrombosis may potentially be a class-wide issue for JAK inhibitors. Portal vein thrombosis may also be a potential risk for ruxolitinib. While these FAERS data add to a growing body of evidence that JAK inhibitors may be contraindicated in patients at risk of thromboembolic events, the data need to be confirmed by future AE reporting trends, analysis of electronic health records, and/or future clinical trials.
      PubDate: 2017-12-02
  • Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for
           Brand Compared with Generic Central Nervous System Drugs
    • Abstract: Introduction Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. Objectives This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. Methods Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For the cohort studies, Cox proportional hazards models were used, controlling for demographic and clinical characteristics as well as the background risk of suicide in the insured population. Results The FAERS analyses found significantly lower suicide reporting rates for brands compared with generics for all four studied products (Breslow–Day P < 0.05). In the claims- and EHR-based cohort study, the adjusted hazard ratio (HR) was statistically significant only for sertraline (HR 0.58; 95% CI 0.38–0.88). Conclusion Suicide reporting rates were disproportionately larger for generic than for brand CNS drugs in FAERS and adjusted retrospective cohort analyses remained significant only for sertraline. However, even for sertraline, temporal confounding related to the close proximity of black box warnings and generic availability is possible. Additional analyses in larger data sources with additional drugs are needed.
      PubDate: 2017-12-02
  • Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine
           Pharmacovigilance Practices Sufficient'
    • PubDate: 2017-12-01
  • Commercial Online Social Network Data and Statin Side-Effect Surveillance:
           A Pilot Observational Study of Aggregate Mentions on Facebook
    • Abstract: Introduction Surveillance of the safety of prescribed drugs after marketing approval has been secured remains fraught with complications. Formal ascertainment by providers and reporting to adverse-event registries, formal surveys by manufacturers, and mining of electronic medical records are all well-known approaches with varying degrees of difficulty, cost, and success. Novel approaches may be a useful adjunct, especially approaches that mine or sample internet-based methods such as online social networks. Methods A novel commercial software-as-a-service data-mining product supplied by Sysomos from Datasift/Facebook was used to mine all mentions on Facebook of statins and stain-related side effects in the US in the 1-month period 9 January 2017 through 8 February 2017. Results A total of 4.3% of all 25,700 mentions of statins also mentioned typical stain-related side effects. Multiple methodological weaknesses stymie interpretation of this percentage, which is however not inconsistent with estimates that 5–20% of patients taking statins will experience typical side effects at some time. Conclusions Future work on pharmacovigilance may be informed by this novel commercial tool, but the inability to mine the full text of a posting poses serious challenges to content categorization.
      PubDate: 2017-12-01
  • Medication Errors: A Characterisation of Spontaneously Reported Cases in
    • Abstract: Introduction Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors. Objective This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002–2015 before the release of EU good practice guidance. Methods Case reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA®) term is reported and included in the Standardised MedDRA® Query (SMQ) for medication errors. These case reports were further categorised by MedDRA® terms, geographical region, patient age group and Anatomical Therapeutic Chemical classification system of suspect medicinal product(s). Results A total of 147,824 case reports were retrieved, 41,355 of which were from the European Economic Area (EEA). Approximately 60% of these case reports were retrieved with the narrow SMQ. The absolute number of medication error case reports and the proportion to the total number of reports in EudraVigilance increased during the study period, with peaks seen around 2005 and 2012 for cases with EEA origin. Fifty-two percent of case reports in which age was provided occurred in adults, 30% in the elderly and 18% in children, with almost half of these in children aged 2 months to 2 years. Conclusion Case reports of medication errors in EudraVigilance steadily increased between 2005 and 2015, the reasons for which may be multifactorial, including increased awareness, changes to the MedDRA® terminology and the 2012 EU pharmacovigilance legislation and associated guidance for stakeholders, or a generally increased risk for errors as more medications become available.
      PubDate: 2017-12-01
  • Is Ribavirin Teratogenic in Humans' No Evidence So Far
    • PubDate: 2017-12-01
  • Suspected Adverse Effects After Human Papillomavirus Vaccination: A
           Temporal Relationship Between Vaccine Administration and the Appearance of
           Symptoms in Japan
    • Abstract: Introduction In Japan, after receiving human papillomavirus vaccination, a significant number of adolescent girls experienced various symptoms, the vast majority of which have been ascribed to chronic regional pain syndrome, orthostatic intolerance, and/or cognitive dysfunction. However, a causal link has not been established between human papillomavirus vaccination and the development of these symptoms. Objective The aim of this study was to clarify the temporal relationship between human papillomavirus vaccination and the appearance of post-vaccination symptoms. Methods Between June 2013 and December 2016, we examined symptoms and objective findings in 163 female patients who had received human papillomavirus vaccination. We used newly defined diagnostic criteria for accurate inclusion of patients who experienced adverse symptoms after human papillomavirus vaccination; these diagnostic criteria were created for this study, and thus their validity and reliability have not been established. Results Overall, 43 female patients were excluded. Among the remaining 120 patients, 30 were diagnosed as having definite vaccine-related symptoms, and 42 were diagnosed as probable. Among these 72 patients, the age at initial vaccination ranged from 11 to 19 years (average 13.6 ± 1.6 years), and the age at appearance of symptoms ranged from 12 to 20 years (average 14.4 ± 1.7 years). The patients received the initial human papillomavirus vaccine injection between May 2010 and April 2013. The first affected girl developed symptoms in October 2010, and the last two affected girls developed symptoms in October 2015. The time to onset after the first vaccine dose ranged from 1 to 1532 days (average 319.7 ± 349.3 days). Conclusions The period of human papillomavirus vaccination considerably overlapped with that of unique post-vaccination symptom development. Based on these sequential events, it is suggested that human papillomavirus vaccination is related to the transiently high prevalence of the previously mentioned symptoms including chronic regional pain syndrome and autonomic and cognitive dysfunctions in the vaccinated patients.
      PubDate: 2017-12-01
  • Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an
           Electronic Medical Records Database: Evidence and Implications
    • Abstract: Introduction Over-the-counter analgesics such as paracetamol and ibuprofen are among the most widely used, and having a good understanding of their safety profile is important to public health. Prior observational studies estimating the risks associated with paracetamol use acknowledge the inherent limitations of these studies. One threat to the validity of observational studies is channeling bias, i.e. the notion that patients are systematically exposed to one drug or the other, based on current and past comorbidities, in a manner that affects estimated relative risk. Objectives The aim of this study was to examine whether evidence of channeling bias exists in observational studies that compare paracetamol with ibuprofen, and, if so, the extent to which confounding adjustment can mitigate this bias. Study Design and Setting In a cohort of 140,770 patients, we examined whether those who received any paracetamol (including concomitant users) were more likely to have prior diagnoses of gastrointestinal (GI) bleeding, myocardial infarction (MI), stroke, or renal disease than those who received ibuprofen alone. We compared propensity score distributions between drugs, and examined the degree to which channeling bias could be controlled using a combination of negative control disease outcome models and large-scale propensity score matching. Analyses were conducted using the Clinical Practice Research Datalink. Results The proportions of prior MI, GI bleeding, renal disease, and stroke were significantly higher in those prescribed any paracetamol versus ibuprofen alone, after adjusting for sex and age. We were not able to adequately remove selection bias using a selected set of covariates for propensity score adjustment; however, when we fit the propensity score model using a substantially larger number of covariates, evidence of residual bias was attenuated. Conclusions Although using selected covariates for propensity score adjustment may not sufficiently reduce bias, large-scale propensity score matching offers a novel approach to consider to mitigate the effects of channeling bias.
      PubDate: 2017-12-01
  • Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from
    • Abstract: Introduction Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. Objectives In this study, we identified drugs suspected to induce dental caries as adverse drug reactions (ADRs) and then studied a possible pathogenic mechanism for each drug that had a statistically significant disproportionality. Methods We extracted individual case safety reports of dental caries associated with drugs from VigiBase® (the World Health Organization global individual case safety report database). We calculated disproportionality for each drug with a reporting odds ratio (ROR) and 99% confidence interval. We analysed the pharmacodynamics of each drug that had a statistically significant disproportionality. Results In VigiBase®, 5229 safety reports for dental caries concerning 733 drugs were identified. Among these drugs, 88 had a significant ROR, and for 65 of them (73.9%), no information about dental caries was found in the summaries of the product characteristics, the Micromedex® DRUGDEX, or the Martindale databases. Regarding the pharmacological classes of drugs involved in dental caries, we identified bisphosphonates, atropinic drugs, antidepressants, corticoids, immunomodulating drugs, antipsychotics, antiepileptics, opioids and β2-adrenoreceptor agonist drugs. Regarding possible pathogenic mechanisms for these drugs, we identified changes in salivary flow/composition for 54 drugs (61.4%), bone metabolism changes for 31 drugs (35.2%), hyperglycaemia for 32 drugs (36.4%) and/or immunosuppression for 23 drugs (26.1%). For nine drugs (10.2%), the mechanism was unclear. Conclusion We identified 88 drugs with a significant positive disproportionality for dental caries. Special attention has to be paid to bisphosphonates, atropinic drugs, immunosuppressants and drugs causing hyperglycaemia.
      PubDate: 2017-12-01
  • Neurological Adverse Effects Attributable to β-Lactam Antibiotics: A
           Literature Review
    • Abstract: β-lactam antibiotics are commonly prescribed antibiotic drugs. To describe the clinical characteristics, risk markers and outcomes of β-lactam antibiotic-induced neurological adverse effects, we performed a general literature review to provide updated clinical data about the most used β-lactam antibiotics. For selected drugs in each class available in France (ticarcillin, piperacillin, temocillin, ceftazidime, cefepime, cefpirome, ceftaroline, ceftobiprole, ceftolozane, ertapenem and aztreonam), a systematic literature review was performed up to April 2016 via an electronic search on PubMed. Articles that reported original data, written in French, Spanish, Portuguese or English, with available individual data for patients with neurological symptoms (such as seizure, disturbed vigilance, confusional state, myoclonia, localising signs, and/or hallucinations) after the introduction of a β-lactam antibiotic were included. The neurological adverse effects of piperacillin and ertapenem are often described as seizures and hallucinations (>50 and 25% of cases, respectively). Antibiotic treatment is often adapted to renal function (>70%), and underlying brain abnormalities are seen in one in four to one in three cases. By contrast, the neurological adverse drug reactions of ceftazidime and cefepime often include abnormal movements but few hallucinations and seizures. These reactions are associated with renal insufficiency (>80%) and doses are rarely adapted to renal function. Otherwise, it appears that monobactams do not have serious neurological adverse drug reactions and that valproic acid and carbapenem combinations should be avoided. The onset of disturbed vigilance, myoclonus, and/or seizure in a patient taking β-lactam antibiotics, especially if associated with renal insufficiency or underlying brain abnormalities, should lead physicians to suspect adverse drug reactions and to consider changes in antibacterial therapy.
      PubDate: 2017-12-01
  • The Ribavirin Pregnancy Registry: An Interim Analysis of Potential
           Teratogenicity at the Mid-Point of Enrollment
    • Abstract: Introduction Significant teratogenic effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in women who are pregnant and in the male sexual partners of women who are pregnant. Both sexes are advised to avoid pregnancy for 6 months after exposure. The Ribavirin Pregnancy Registry was established in 2003 to monitor pregnancy exposures to ribavirin for signals of possible human teratogenicity. Methods This voluntary registry enrolls pregnant women with prenatal exposure to ribavirin. Exposure is classified as direct—women taking ribavirin during pregnancy or the 6 months prior to conception—or indirect—women exposed through sexual contact, 6 months prior to or during pregnancy, with a man who is taking or has taken ribavirin in the past 6 months. Women are followed until delivery and infants for 1 year. When enrollment is complete, birth defect rates will be compared with the Metropolitan Atlanta Congenital Defects Program’s published rate of 2.67. Using data collected since inception in 2003 through February 2016, preliminary rates were calculated. Results The registry has enrolled 272 pregnant women, with 180 live births: there were seven birth defect cases among 85 directly exposed women [7/85 (8.2%) (95% confidence interval (CI) 3.4–16.2)] and four birth defect cases among 95 indirectly exposed women [4/95 (4.2%) (95% CI 1.2–10.4)]. Of the 11 infants, nine had structural defects and two had chromosomal anomalies. Patterns suggesting a common etiology or relationship with ribavirin exposure are not seen. Conclusion Based on the patterns of birth defects reported, preliminary findings do not suggest a clear signal of human teratogenicity for ribavirin. However, the current sample size is insufficient for definitive conclusions, and ribavirin exposure should be avoided during pregnancy and during the 6 months prior to pregnancy, in accordance with prescribing information. Clinical Trial Registration identifier: NCT00114712.
      PubDate: 2017-12-01
  • Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with
           Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of
           Post-Marketing Experience
    • Abstract: Introduction Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. Objective The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. Methods We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. Results From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at daily doses of 1200 mg. Other adverse drug reactions reported in post-marketing surveillance are seizure (5.8%), dizziness (4.1%), rash (2.6%), and fatigue (2.1%). The safety profile of eslicarbazepine acetate in renal and hepatic impairment subjects (phase I studies) and in elderly patients (phase III study) did not raise any specific concern. Conclusion After 6 years of post-marketing surveillance, eslicarbazepine acetate maintains a similar safety profile to that observed in pivotal clinical studies.
      PubDate: 2017-12-01
  • A Pharmacoepidemiology Database System for Monitoring Risk Due to the Use
           of Medicines by New Zealand Primary Care Patients
    • Abstract: Introduction The use of large record-linked healthcare databases for drug safety research and surveillance is now accepted practice. New Zealand’s standardized national healthcare datasets provide the potential to automate the conduct of pharmacoepidemiological studies to provide rapid validation of medicine safety signals. Objectives Our objectives were to describe the methodology undertaken by a semi-automated computer system developed to rapidly assess risk due to drug exposure in New Zealand’s population of primary care patients and to compare results from three studies with previously published findings. Methods Data from three national databases were linked at the patient level in the automated studies. A retrospective nested case–control design was used to evaluate risk for upper gastrointestinal bleeding (UGIB), acute kidney failure (AKF), and serious arrhythmia associated with individual medicines, therapeutic classes of medicines, and concurrent use of medicines from multiple therapeutic classes. Results The patient cohort available for each study included 5,194,256 patients registered between 2007 and 2014, with a total of 34,630,673 patient-years at risk. An increased risk for UGIB was associated with non-steroidal anti-inflammatory drugs (NSAIDs) (adjusted odds ratio [AOR] 4.16, 95% confidence interval [CI] 3.90–4.43, p < 0.001) and selective serotonin reuptake inhibitors (AOR 1.39, 95% CI 1.20–1.62, p < 0.001); an increased risk for AKF was associated with NSAIDs (AOR 1.78, 95% CI 1.73–1.83, p < 0.001) and proton pump inhibitors (AOR 1.78, 95% CI 1.72–1.83, p < 0.001); and an increased risk for serious arrhythmia was associated with fluoroquinolones (AOR 1.38, 95% CI 1.26–151, p < 0.001) and penicillins (AOR 1.69, 95% CI 1.61–1.77, p < 0.001). Conclusions Automated case–control studies using New Zealand’s healthcare datasets can replicate associations of risk with drug exposure consistent with previous findings. Their speed of conduct enables systematic monitoring of risk for adverse events associated with a wide range of medicines.
      PubDate: 2017-12-01
  • An Automated System Combining Safety Signal Detection and Prioritization
           from Healthcare Databases: A Pilot Study
    • Abstract: Introduction Signal detection from healthcare databases is possible, but is not yet used for routine surveillance of drug safety. One challenge is to develop methods for selecting signals that should be assessed with priority. Aim The aim of this study was to develop an automated system combining safety signal detection and prioritization from healthcare databases and applicable to drugs used in chronic diseases. Methods Patients present in the French EGB healthcare database for at least 1 year between 2005 and 2015 were considered. Noninsulin glucose-lowering drugs (NIGLDs) were selected as a case study, and hospitalization data were used to select important medical events (IME). Signal detection was performed quarterly from 2008 to 2015 using sequence symmetry analysis. NIGLD/IME associations were screened if one or more exposed case was identified in the quarter, and three or more exposed cases were identified in the population at the date of screening. Detected signals were prioritized using the Longitudinal-SNIP (L-SNIP) algorithm based on strength (S), novelty (N), and potential impact of signal (I), and pattern of drug use (P). Signals scored in the top 10% were identified as of high priority. A reference set was built based on NIGLD summaries of product characteristics (SPCs) to compute the performance of the developed system. Results A total of 815 associations were screened and 241 (29.6%) were detected as signals; among these, 58 (24.1%) were prioritized. The performance for signal detection was sensitivity = 47%; specificity = 80%; positive predictive value (PPV) 33%; negative predictive value = 82%. The use of the L-SNIP algorithm increased the early identification of positive controls, restricted to those mentioned in the SPCs after 2008: PPV = 100% versus PPV = 14% with its non-use. The system revealed a strong new signal with dipeptidylpeptidase-4 inhibitors and venous thromboembolism. Conclusion The developed system seems promising for the routine use of healthcare data for safety surveillance of drugs used in chronic diseases.
      PubDate: 2017-11-28
  • Using Human ‘Experiments of Nature’ to Predict Drug Safety Issues: An
           Example with PCSK9 Inhibitors
    • Abstract: Introduction When a new drug enters the market, its full array of side effects remains to be defined. Current surveillance approaches targeting these effects remain largely reactive. There is a need for development of methods to predict specific safety events that should be sought for a given new drug during development and postmarketing activities. Objective We present here a safety signal identification approach applied to a new set of drug entities, inhibitors of the serine protease proprotein convertase subtilisin/kexin type 9 (PCSK9). Methods Using phenome-wide association study (PheWAS) methods, we analyzed available genotype and clinical data from 29,722 patients, leveraging the known effects of changes in PCSK9 to identify novel phenotypes in which this protein and its inhibitors may have impact. Results PheWAS revealed a significantly reduced risk of hypercholesterolemia (odds ratio [OR] 0.68, p = 7.6 × 10−4) in association with a known loss-of-function variant in PCSK9, R46L. Similarly, laboratory data indicated significantly reduced beta mean low-density lipoprotein cholesterol (− 14.47 mg/dL, p = 2.58 × 10−23) in individuals carrying the R46L variant. The R46L variant was also associated with an increased risk of spina bifida (OR 5.90, p = 2.7 × 10−4), suggesting that further investigation of potential connections between inhibition of PCSK9 and neural tube defects may be warranted. Conclusion This novel methodology provides an opportunity to put in place new mechanisms to assess the safety and long-term tolerability of PCSK9 inhibitors specifically, and other new agents in general, as they move into human testing and expanded clinical use.
      PubDate: 2017-11-28
  • Comment on: “Adverse Drug Reaction-Related Hospitalizations in Elderly
           Australians: A Prospective Cross-Sectional Study in Two Tasmanian
    • PubDate: 2017-11-15
  • Authors’ Reply to Mona Kargar and Colleagues’ Comment on “Adverse
           Drug Reaction-Related Hospitalizations in Elderly Australians: A
           Prospective Cross-Sectional Study in Two Tasmanian Hospitals”
    • PubDate: 2017-11-13
  • Acknowledgement to Referees
    • PubDate: 2017-11-11
  • Correction to: Medication Errors: A Characterisation of Spontaneously
           Reported Cases in EudraVigilance
    • Abstract: Correction to: Drug Saf
      DOI 10.1007/s40264-017-0569-3.
      PubDate: 2017-11-07
  • Correction to: Safety Concerns with HPV Vaccines Continue to Linger: Are
           Current Vaccine Pharmacovigilance Practices Sufficient'
    • Abstract: The following disclaimer was missing from the article.
      PubDate: 2017-10-28
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