Authors ’ Response to Braillon’s Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”
(Source: Drug Safety)
Source: Drug Safety - August 17, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”
(Source: Drug Safety)
Source: Drug Safety - August 17, 2018 Category: Drugs & Pharmacology Source Type: research

The Prevalence of Dose Errors Among Paediatric Patients in Hospital Wards with and without Health Information Technology: A Systematic Review and Meta-Analysis
ConclusionsDose errors occur in approximately 1 in 20 medication orders. Hospitals using CPOE with or without CDS had a lower rate of dose errors compared with those using paper charts. However, few pre/post studies have been conducted and none reported a significant reduction in dose error rates associated with the introduction of CPOE. Future research employing controlled designs is needed to determine the true impact of CPOE on dosing errors among children, and any associated patient harm. (Source: Drug Safety)
Source: Drug Safety - August 16, 2018 Category: Drugs & Pharmacology Source Type: research

A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries
ConclusionsOur findings demonstrate that algorithmic and temporal assessment increased specificity of case retrieval, though the reduction in the number of terms or incidence seemed excessive for certain aSMQs. Evaluating the day of AE onset and duration improve specificity through identification of outlying events. Identification of drug classes known to cause the aSMQ ’s clinical condition provides face validity for this tool, yet detection of cases associated with novel classes may provide new understanding of these disorders. Improvements in some of the SMQ term lists may improve the performance of SMQs in genera...
Source: Drug Safety - August 16, 2018 Category: Drugs & Pharmacology Source Type: research

Stevens –Johnson Syndrome and Toxic Epidermal Necrolysis in Association with Commonly Prescribed Drugs in Outpatient Care Other than Anti-Epileptic Drugs and Antibiotics: A Population-Based Case–Control Study
ConclusionsIn this observational study, we observed likely causal associations between Stevens –Johnson syndrome/toxic epidermal necrolysis and use of allopurinol, cyclooxygenase-2 inhibitors, and 5-aminosalicylates, and potential associations for proton pump inhibitors, fluoxetine, and mirtazapine. (Source: Drug Safety)
Source: Drug Safety - August 16, 2018 Category: Drugs & Pharmacology Source Type: research

Potential Risk Window for Opioid Overdose Related to Treatment with Extended-Release Injectable Naltrexone
(Source: Drug Safety)
Source: Drug Safety - August 2, 2018 Category: Drugs & Pharmacology Source Type: research

Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration ’s Adverse Event Reporting System
ConclusionsInclusion of lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two drugs subject to high-profile tort litigation for other AEs. (Source: Drug Safety)
Source: Drug Safety - August 1, 2018 Category: Drugs & Pharmacology Source Type: research

Reply to Ward and Colleagues ’ Comment on “Using Human Experiments of Nature to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors”
(Source: Drug Safety)
Source: Drug Safety - July 31, 2018 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa
ConclusionsThe rates of AEs were lowest among patients receiving a TDF-based second-line regimen. Patients with poorer health at the time of switch were at higher risk of AEs when receiving second-line ART and may require closer monitoring to improve the durability of second-line therapy. (Source: Drug Safety)
Source: Drug Safety - July 24, 2018 Category: Drugs & Pharmacology Source Type: research

Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project
ConclusionsOur results clearly suggest that broad-ranging statistical signal detection in Twitter and Facebook, using currently available methods for adverse event recognition, performs poorly and cannot be recommended at the expense of other pharmacovigilance activities. (Source: Drug Safety)
Source: Drug Safety - July 24, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
In the original publication of the article, the trend line for non-EEA cases in figure  4 is incorrect. In this correction, the original Fig. 4 (Fig. 1) and the correct Fig. 4 (Fig. 2) are published. (Source: Drug Safety)
Source: Drug Safety - July 20, 2018 Category: Drugs & Pharmacology Source Type: research

Safety Profile of Benznidazole in the Treatment of Chronic Chagas Disease: Experience of a Referral Centre and Systematic Literature Review with Meta-Analysis
ConclusionBenznidazole had a poor tolerability profile, with a high incidence of TDs, especially in adult patients and women. Optimised dosing schedules and/or new drugs are urgently needed. (Source: Drug Safety)
Source: Drug Safety - July 13, 2018 Category: Drugs & Pharmacology Source Type: research

Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006 –2015
ConclusionsOver the period 2006 –2015 outpatient use of antibiotics decreased substantially among adults. Rapid shifts in use occurring in 2008 and 2013 may reflect the presence of key drivers of change, such as abrupt changes in access to care or perceived antibiotic safety. (Source: Drug Safety)
Source: Drug Safety - July 9, 2018 Category: Drugs & Pharmacology Source Type: research

Role of Serotonin Transporter in Antidepressant-Induced Diabetes Mellitus: A Pharmacoepidemiological –Pharmacodynamic Study in VigiBase ®
ConclusionThe present study suggests a potential role for serotonin transporter in antidepressant-induced type 2 diabetes. (Source: Drug Safety)
Source: Drug Safety - June 28, 2018 Category: Drugs & Pharmacology Source Type: research

Gabapentin and Pregabalin and Risk of Atrial Fibrillation in the Elderly: A Population-Based Cohort Study in an Electronic Prescription Database
ConclusionIn elderly patients free of cardiovascular disease, an association between new exposure to gabapentin or pregabalin and initiating treatment for AF was found. These results should be confirmed in other studies. (Source: Drug Safety)
Source: Drug Safety - June 28, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on “Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence”
(Source: Drug Safety)
Source: Drug Safety - June 28, 2018 Category: Drugs & Pharmacology Source Type: research

Authors ’ Response to Silverman and Colleagues’ Comment on “Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence”
(Source: Drug Safety)
Source: Drug Safety - June 28, 2018 Category: Drugs & Pharmacology Source Type: research

What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects
AbstractAdverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at universities for medical, pharmacy, dentistry and nursing students, so a core curriculum needs to be developed to teach important aspects of PV to students. In September 2016, a stakeholders ’ meeting was initiated on behalf of the World Health Organization (WHO) and organized by the Netherlands ...
Source: Drug Safety - June 13, 2018 Category: Drugs & Pharmacology Source Type: research

Predicting Adverse Drug Effects from Literature- and Database-Mined Assertions
ConclusionsThe presented workflow, based on free-access databases and an association-based inference scheme, provided novel C –E relationships that have been validated post hoc in case reports. With refinement of prioritization schemes for the generated C–E inferences, this workflow may provide an effective computational method for the early detection of potential drug candidate ADEs that can be followed by targeted ex perimental investigations. (Source: Drug Safety)
Source: Drug Safety - June 6, 2018 Category: Drugs & Pharmacology Source Type: research

MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A Decision Support Tool for Safety Scientists
ConclusionAnalysis suggests that the MONARCSi model could potentially be a useful decision support tool to assist pharmacovigilance safety professionals when evaluating drug-event causality in a consistent and documentable manner. (Source: Drug Safety)
Source: Drug Safety - June 6, 2018 Category: Drugs & Pharmacology Source Type: research

Cardiac Complications Attributed to Chloroquine and Hydroxychloroquine: A Systematic Review of the Literature
ConclusionsClinicians should be warned that chloroquine- or hydroxychloroquine-related cardiac manifestations, even conduction disorders without repercussion, may be initial manifestations of toxicity, and are potentially irreversible. Therefore, treatment withdrawal is required when cardiac manifestations are present. (Source: Drug Safety)
Source: Drug Safety - June 1, 2018 Category: Drugs & Pharmacology Source Type: research

Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample
ConclusionsThere was no evidence for an increased risk of ACS in patients dispensed ibuprofen compared to paracetamol. (Source: Drug Safety)
Source: Drug Safety - May 24, 2018 Category: Drugs & Pharmacology Source Type: research

Association of Statin Use with Increased Risk of Musculoskeletal Conditions: A Retrospective Cohort Study
ConclusionStatin use was associated with a significant increased risk of non-traumatic arthropathies and use-related injury. Our results provide additional data that can inform patient and clinician conversations about the benefits and risks of statin use. (Source: Drug Safety)
Source: Drug Safety - May 24, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence
Introduction 3rd Paragraph. (Source: Drug Safety)
Source: Drug Safety - May 24, 2018 Category: Drugs & Pharmacology Source Type: research

Prescription Opioid Fatalities: Examining Why the Healer Could be the Culprit
AbstractPrescription opioid use has increased rapidly in developed countries, as have fatalities and other related adverse events. This review examines the intrinsic characteristics of opioids, including their mechanisms of action and pharmacokinetic and pharmacodynamic properties, to determine how the use of a regonised pharmacological remedy for a medically confirmed ailment could result in an accidental fatality. Opioids trigger biological processes that inhibit their own therapeutic effect. Prolonged use of opioids can result in activation of pronociceptive systems, leading to opioid-induced hyperalgesia and tolerance,...
Source: Drug Safety - May 23, 2018 Category: Drugs & Pharmacology Source Type: research

Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction
AbstractIn recent years, marketing of highly innovative and costly biologics improved the management of high-burden diseases such as autoimmune diseases, cancers, and chronic renal failure. Several widely prescribed biologics have recently lost or will shortly lose their patents, thus opening avenues to the marketing of a growing number of biosimilars worldwide, which are products similar in terms of quality, safety, and efficacy to already licensed reference products, thus allowing for potential savings in pharmaceutical expenditure. Numerous debates about the interchangeability between biosimilars and reference products ...
Source: Drug Safety - May 23, 2018 Category: Drugs & Pharmacology Source Type: research

Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice
ConclusionStatistically significant associations of levonorgestrel exposure with anxiety and sleep problems were observed. Substantive differences in baseline characteristics of the treated groups make robust conclusions difficult but the results strongly suggest that additional studies are warranted. (Source: Drug Safety)
Source: Drug Safety - May 21, 2018 Category: Drugs & Pharmacology Source Type: research

Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study
The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.MethodsThe app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive ...
Source: Drug Safety - May 14, 2018 Category: Drugs & Pharmacology Source Type: research

Vitamin B 6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases
AbstractIntroductionIn the literature, vitamin B6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B6 for a long time. Evidence as to whether a lower dosage range of vitamin B6 (
Source: Drug Safety - May 8, 2018 Category: Drugs & Pharmacology Source Type: research

A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials
ConclusionWe suggest that this programme could serve as a model for pragmatic screening for PML during the clinical development of new drugs. (Source: Drug Safety)
Source: Drug Safety - May 8, 2018 Category: Drugs & Pharmacology Source Type: research

Inadequate harms reporting in randomized control trials of antibiotics for pediatric acute otitis media: a systematic review
ConclusionsHarms reporting in pediatric randomized trials, especially the reporting of methods used to collect harms data, remains inadequate. (Source: Drug Safety)
Source: Drug Safety - May 8, 2018 Category: Drugs & Pharmacology Source Type: research

Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children
DiscussionNo unexpected AEs were observed in an all-comers population treated with tamsulosin for various conditions/symptoms. The overall safety profile in women and children seemed to be generally consistent with the profile in men, the indicated population. (Source: Drug Safety)
Source: Drug Safety - May 8, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase
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. (Source: Drug Safety)
Source: Drug Safety - May 8, 2018 Category: Drugs & Pharmacology Source Type: research

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study
ConclusionsCPRD can routinely provide useful early insights into clinical context when assessing a large proportion of safety signals within a regulatory environment provided that a flexible approach is adopted within the analysis platform. (Source: Drug Safety)
Source: Drug Safety - May 3, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on: “All-Cause and Drug-Related Medical Events Associated with Overuse of Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a Commercially Insured US Population”
(Source: Drug Safety)
Source: Drug Safety - May 3, 2018 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to: Tomoyuki Kawada’s Comment on: “All-Cause and Drug-Related Medical Events Associated with Overuse of Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a Commercially Insured US Population’’
(Source: Drug Safety)
Source: Drug Safety - May 3, 2018 Category: Drugs & Pharmacology Source Type: research

Challenges and Opportunities for the Traceability of (Biological) Medicinal Products
This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited traceability of biologics, in particular with regard to the batch number, is associated with incomplete recording of exposure information in clinical practice. The current pharmaceutical barcode standards in the EU do not support the automatic recording of dynamic product information, such as batch numbers and expiry dates, by means of electronic barcode scanning in clinical practice. New barcode requirements, such as the 2D DataMatrix with encoded batch numbers and...
Source: Drug Safety - May 2, 2018 Category: Drugs & Pharmacology Source Type: research

Active Safety Surveillance in Africa: Pragmatism and Agility
(Source: Drug Safety)
Source: Drug Safety - May 2, 2018 Category: Drugs & Pharmacology Source Type: research

Potentially Inappropriate Medication Prescribing and Risk of Unplanned Hospitalization among the Elderly: A Self-Matched, Case-Crossover Study
ConclusionsElderly patients commonly used PIMs, especially antidiabetics and diuretics. PIM use was associated with a 1.5- to 4-fold increase in the ORs of unplanned hospitalization among them. (Source: Drug Safety)
Source: Drug Safety - April 30, 2018 Category: Drugs & Pharmacology Source Type: research

Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis
ConclusionResults of this nationwide study suggest that DOACs are associated with rare but severe liver injury and more frequent gastrointestinal disorders. A low risk of kidney injury with DOAC therapy can also not be excluded. (Source: Drug Safety)
Source: Drug Safety - April 30, 2018 Category: Drugs & Pharmacology Source Type: research

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial
AbstractAdministrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data. Drug safety researchers need to continue advancing their knowledge of the data resourc...
Source: Drug Safety - April 30, 2018 Category: Drugs & Pharmacology Source Type: research

Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA)
ConclusionThe incidence of common AEs among patients treated with Inj AS in real-world settings was found to be relatively low. Future studies should consider larger cohorts to document rare AEs as well.ClinicalTrials.gov IdentifierNCT02817919. (Source: Drug Safety)
Source: Drug Safety - April 25, 2018 Category: Drugs & Pharmacology Source Type: research

Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study
ConclusionThe response rate to the survey was low, and the tools displayed limited utility and effectiveness in improving awareness and education in a small number of responders. Therefore, the aripiprazole risk management plan was amended, and the tools were discontinued. (Source: Drug Safety)
Source: Drug Safety - April 18, 2018 Category: Drugs & Pharmacology Source Type: research

Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis
ConclusionThere are differences in data on rates of SAEs and mortality in randomized clinical trials in both ClinicalTrials.gov and journal articles compared with FDA reviews. Further efforts should focus on decreasing existing discrepancies to enhance the transparency and reproducibility of data reporting in clinical trials. (Source: Drug Safety)
Source: Drug Safety - April 11, 2018 Category: Drugs & Pharmacology Source Type: research

The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study
ConclusionThe burden of ADRs is high among women and in patients from urban settings and those with comorbidities. Such risk factors need to be considered in order to optimise therapy. Close monitoring of ADRs is key in implementation of the malaria treatment policy. (Source: Drug Safety)
Source: Drug Safety - April 7, 2018 Category: Drugs & Pharmacology Source Type: research

Osteoporosis-Related Fractures in HIV-Infected Patients Receiving Long-Term Tenofovir Disoproxil Fumarate: An Observational Cohort Study
ConclusionsAmong HIV-infected patients in Japan, treatment with TDF for  ≥ 5 years increases the risk of bone fractures in younger men, in addition to that seen in older post-menopausal women. (Source: Drug Safety)
Source: Drug Safety - April 5, 2018 Category: Drugs & Pharmacology Source Type: research

Use of Proton Pump Inhibitors and the Risk of Acute Kidney Injury Among Patients with Rheumatoid Arthritis: Cohort Study
ConclusionsThis cohort study among patients with rheumatoid arthritis found a significantly increased risk of acute kidney injury associated with the use of proton pump inhibitors. These findings may help inform clinical decision making when considering the risks and benefits of proton pump inhibitor treatment in rheumatoid arthritis. (Source: Drug Safety)
Source: Drug Safety - March 30, 2018 Category: Drugs & Pharmacology Source Type: research

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems
ConclusionsNotwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status. (Source: Drug Safety)
Source: Drug Safety - March 26, 2018 Category: Drugs & Pharmacology Source Type: research

Comparative Rates of Mortality and Serious Adverse Effects Among Commonly Prescribed Opioid Analgesics
Conclusions and RelevancePotency of a prescription opioid analgesic demonstrates a significant, highly positive linear relationship with exposures resulting in SAEs per 100  kg drug dispensed reported to poison centers. Potency should be carefully considered from both individual provider and public health perspectives. (Source: Drug Safety)
Source: Drug Safety - March 26, 2018 Category: Drugs & Pharmacology Source Type: research

Benefit –Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
ConclusionThe use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data. (Source: Drug Safety)
Source: Drug Safety - March 26, 2018 Category: Drugs & Pharmacology Source Type: research