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

Authors ’ reply: Safety of Human Papillomavirus Vaccines
(Source: Drug Safety)
Source: Drug Safety - March 26, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on: “Safety of Human Papillomavirus Vaccines: An Updated Review”
(Source: Drug Safety)
Source: Drug Safety - March 23, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on “Safety of Human Papillomavirus Vaccines: An Updated Review”
(Source: Drug Safety)
Source: Drug Safety - March 23, 2018 Category: Drugs & Pharmacology Source Type: research

Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence
ConclusionsVivitrol adverse event reports suggest the need to investigate two  months following the last medicine injection as a period of particular concern for overdose. A registry study would best quantify risk. Providers should report suspected post-discontinuation overdoses to government authorities. (Source: Drug Safety)
Source: Drug Safety - March 20, 2018 Category: Drugs & Pharmacology Source Type: research

Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database
ConclusionIn VAERS, MS cases were up to five times more likely to be reported after an HB vaccination than after any other vaccination. Since DPA is mainly suited for hypothesis generation, further studies evaluating the nature of the link between MS and HB vaccination would be of considerable importance. (Source: Drug Safety)
Source: Drug Safety - March 20, 2018 Category: Drugs & Pharmacology Source Type: research

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection
We describe the results, including by type of publication, research topics and drugs involved. In 50% of the publications, the data are used to describe safety issues, in 44% to analyse methodologies used in pharmacovigilance activities and in 6% to support clinical perspectives. We also outline a description of the use of the database by the European Union regulatory network. Driven by the full implementation of the 2010 pharmacovigilance legislation, EudraVigilance has undergone further enhancements together with a major revision of its access policy, taking into account the use of the new individual case safety report s...
Source: Drug Safety - March 9, 2018 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Liver Injury: Why is the Roussel Uclaf Causality Assessment Method (RUCAM) Still Used 25  Years After Its Launch?
This article is intended to encourage systematic use of sophisticated causality assessment methods such as RUCAM to improve DILI and HILI case evaluation and to increase confidence in published cases. (Source: Drug Safety)
Source: Drug Safety - March 3, 2018 Category: Drugs & Pharmacology Source Type: research

Thromboembolism with Janus Kinase (JAK) Inhibitors for Rheumatoid Arthritis: How Real is the Risk?
AbstractTwo different Janus kinase (JAK) inhibitors —baricitinib and tofacitinib—are effective and licensed in active rheumatoid arthritis (RA). There have been recent concerns about potential thromboembolic risks with these drugs. Concerns about baricitinib focus on clinical trial findings. Using all publically available data, we estimate thromb oembolic risks are approximately five events per 1000 patient years with 4 mg baricitinib daily. Concerns about tofacitinib have been raised by analyses of the Federal Drug Administration Adverse Event Reporting System (FAERs). These show some evidence of increase...
Source: Drug Safety - March 2, 2018 Category: Drugs & Pharmacology Source Type: research

Safety Communication Tools and Healthcare Professionals ’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study
ConclusionsGPs, cardiologists, and pharmacists were to a similar extent (highly) familiar with DHPCs, but they differed in awareness levels of specific safety issues. Cardiologists were less aware of safety issues associated with non-cardiology drugs even if these had cardiovascular safety concerns. This implies that additional strategies may be needed to reach specialists when communicating safety issues regarding drugs outside their therapeutic area but with risks related to their field of specialisation. DHPCs were an important source for the different professions to become aware of specific safety issues, but other sou...
Source: Drug Safety - March 2, 2018 Category: Drugs & Pharmacology Source Type: research

Interest in a Mobile App for Two-Way Risk Communication: A Survey Study Among European Healthcare Professionals and Patients
ConclusionsAn app is positively perceived by HCPs and patients for reporting ADRs quickly and for receiving drug safety information from national medicines agencies. In particular, HCPs and patients who already use other health apps were interested in the app. (Source: Drug Safety)
Source: Drug Safety - March 2, 2018 Category: Drugs & Pharmacology Source Type: research

Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants
ConclusionThrough a symmetry analysis-based hypothesis-free screening of large-scale healthcare databases, we were able to confirm well-established AEs of NOAC therapy in clinical practice as well as potential AEs that deserve further investigation. (Source: Drug Safety)
Source: Drug Safety - March 1, 2018 Category: Drugs & Pharmacology Source Type: research

Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience
ConclusionsAlthough the incidence of overall AEs, SAEs, and deaths was similar between fasiglifam and placebo, a liver signal was identified based primarily on the difference in liver chemistry values in the fasiglifam group compared with the placebo and active comparator groups. Three serious liver injuries were attributed to fasiglifam treatment. Clinical development of fasiglifam was halted due to these liver safety concerns. (Source: Drug Safety)
Source: Drug Safety - February 28, 2018 Category: Drugs & Pharmacology Source Type: research

Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring
AbstractCurrently, there is a lack of international and national guidelines or consensus documents with specific recommendations for electrocardiogram (ECG) screening and monitoring during antidepressant treatment. To make a proper estimation of the risk of cardiac arrhythmias and sudden (cardiac) death during antidepressant use, both the drug and patient-specific factors should be taken into account; however, solid evidence on how this should be done in clinical practice is lacking. Available recommendations on the management of QT(c) prolongation (with antidepressant treatment) emphasize that special attention should be ...
Source: Drug Safety - February 26, 2018 Category: Drugs & Pharmacology Source Type: research

The Risk for Lung Cancer Incidence with Calcium Channel Blockers: A Systematic Review and Meta-Analysis of Observational Studies
ConclusionsOur analysis suggests exposure to CCBs is associated with an increased risk of lung cancer. Considering their widespread use, and the paucity of data on the long-term effects of chronic exposure to CCBs, these results are reason for concern and warrant further investigation.Systematic Review RegistrationThe protocol for this study was registered at the PROSPERO registry of systematic reviews (registry number: CRD42017056362). (Source: Drug Safety)
Source: Drug Safety - February 26, 2018 Category: Drugs & Pharmacology Source Type: research

Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors
ConclusionADRs more reported in women than men when using SSRIs were usually dose-related ADRs or commonly occurring ADRs. Differences in the pharmacokinetics of SSRIs between men and women may explain why these reports of dose-related ADRs when using SSRIs concern women more than men. (Source: Drug Safety)
Source: Drug Safety - February 26, 2018 Category: Drugs & Pharmacology Source Type: research

Time Series Disturbance Detection for Hypothesis-Free Signal Detection in Longitudinal Observational Databases
ConclusionOverall, the disturbance algorithm approach shows promising capacity for detecting outliers, and shows tractability of the algorithmic approach for large-scale screening. The method offers an array of pattern types for detection and clinical review. (Source: Drug Safety)
Source: Drug Safety - February 21, 2018 Category: Drugs & Pharmacology Source Type: research

Glucocorticoids and the Risk of Peptic Ulcer Bleeding: Case –Control Analysis Based on Swiss Claims Data
ConclusionsThe use of NSAIDs with or without GC was associated with a markedly higher risk of PUB compared with GC monotherapy. Use of GC alone was associated with a moderately increased risk of PUB, which might be causal or attributed to confounding by indication. (Source: Drug Safety)
Source: Drug Safety - February 21, 2018 Category: Drugs & Pharmacology Source Type: research

Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media
ConclusionThe results of this study indicate that an effective and scalable solution to the challenge of ICSR detection in SDM includes a workflow using an automated ML classifier to identify likely ICSRs for further human SME review. (Source: Drug Safety)
Source: Drug Safety - February 14, 2018 Category: Drugs & Pharmacology Source Type: research

Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA ’s Adverse Event Reporting System
ConclusionThese findings extend previous evidence showing that significantly elevated ALS reporting extends to individual statin agents, and add to concerns about potential elevated occurrence of ALS-like conditions in association with statin usage. (Source: Drug Safety)
Source: Drug Safety - February 9, 2018 Category: Drugs & Pharmacology Source Type: research

A Multi-hospital Before –After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors
AbstractIntroductionWe previously found a high rate of errors in the administration of intravenous medications using smart infusion pumps.Objectives/DesignAn infusion safety intervention bundle was developed in response to the high rate of identified errors. A before –after observational study with a prospective point-prevalence approach was conducted in nine hospitals to measure the preliminary effects of the intervention.Main Outcome MeasuresPrimary outcome measures were overall errors and medication errors, with the secondary outcome defined as potentially harmful error rates.ResultsWe assessed a total of 418 pati...
Source: Drug Safety - February 6, 2018 Category: Drugs & Pharmacology Source Type: research

Potential Risks Related to Modulating Interleukin-13 and Interleukin-4 Signalling: A Systematic Review
ConclusionsAlthough our findings are reassuring, long-term safety assessments of biologics that target the interleukin-13/interleukin-4 pathways currently in clinical development are needed. (Source: Drug Safety)
Source: Drug Safety - February 6, 2018 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Ototoxicity: Diagnosis and Monitoring
AbstractOtotoxicity diagnosis and management has historically been approached using a variety of methods. However, in recent years a consensus on useful and practical approaches has been developed through clinical guidelines of the American Speech Language Hearing Association, the American Academy of Audiology, and multiple clinical trials published in peer-reviewed literature. Some of the guidelines and approaches are used to detect and monitor ototoxicity, while others are used to grade adverse events. Some of the audiologic measures are primary, while others are adjunct measures and may be tailored to the specific needs...
Source: Drug Safety - February 6, 2018 Category: Drugs & Pharmacology Source Type: research

The Uncertainty of the Association Between Proton Pump Inhibitor Use and the Risk of Dementia: Prescription Sequence Symmetry Analysis Using a Korean Healthcare Database Between 2002 and 2013
In this study, we applied the 3-year time window. So the patients who initiated PPIs 3 years before or after their first diagnosis of dementia were included. The pairs with the time window
Source: Drug Safety - February 3, 2018 Category: Drugs & Pharmacology Source Type: research

Gastrointestinal Perforations with Biologics in Patients with Rheumatoid Arthritis: Implications for Clinicians
AbstractGastrointestinal (GI) perforations are rare events in rheumatoid arthritis (RA) patients, but cause significant morbidity and mortality. Several studies indicate that RA patients may be at higher risk of GI perforation. Traditional RA treatments such as glucocorticoids and non-steroidal anti-inflammatory drugs increase the risk of perforation. In the past two decades, a new class of therapeutic agents called biologics has been added to the RA treatment armamentarium. Biologics are effective in controlling disease activity and are generally well tolerated; however, reports of GI perforations in association with biol...
Source: Drug Safety - February 1, 2018 Category: Drugs & Pharmacology Source Type: research

Long-Acting β2-Agonists in Asthma: Enantioselective Safety Studies are Needed
AbstractLong-acting β2-agonists (LABAs) such as formoterol and salmeterol are used for prolonged bronchodilatation in asthma, usually in combination with inhaled corticosteroids (ICSs). Unexplained paradoxical asthma exacerbations and deaths have been associated with LABAs, particularly when used without ICS. LABAs cl early demonstrate effective bronchodilatation and steroid-sparing activity, but long-term treatment can lead to tolerance of their bronchodilator effects. There are also concerns with regard to the effects of LABAs on bronchial hyperresponsiveness (BHR), where long-term use is associated with increa sed ...
Source: Drug Safety - January 13, 2018 Category: Drugs & Pharmacology Source Type: research

Evidence-Based Recommendations to Improve the Safe Use of Drugs in Patients with Liver Cirrhosis
ConclusionsOver 200 recommendations were developed for the safe use of drugs in patients with liver cirrhosis. Implementing these recommendations into clinical practice can possibly enhance medication safety in this vulnerable patient group. (Source: Drug Safety)
Source: Drug Safety - January 12, 2018 Category: Drugs & Pharmacology Source Type: research

Case Series Analysis of New Zealand Reports of Rapid Intense Potentiation of Warfarin by Roxithromycin
ConclusionIn this case series, the high prevalence of acute polypharmacy, including potentially interacting medicines, and serious infection suggests that they may have contributed to warfarin potentiation and increased the clinical significance of a roxithromycin/warfarin interaction. (Source: Drug Safety)
Source: Drug Safety - January 12, 2018 Category: Drugs & Pharmacology Source Type: research

Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database
ConclusionSCCS shows promise for signal detection: it may highlight known associations for recent marketed products and has potential for early signal identification. SCCS performance varied by design choice and the nature of both exposure and event pair. Future work is needed to determine how effective the approach is in prospective testing and determining the performance characteristics of the approach. (Source: Drug Safety)
Source: Drug Safety - January 11, 2018 Category: Drugs & Pharmacology Source Type: research

The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review
ConclusionsTreatment with biologic or tofacitinib appears to be well-tolerated with respect to CV outcomes in these patients. (Source: Drug Safety)
Source: Drug Safety - January 9, 2018 Category: Drugs & Pharmacology Source Type: research

A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials
AbstractPediatric psychotropic prescription rates are rising, emphasizing the need for careful monitoring of drug safety in this population. Currently, no standardized assessments are used in clinical trials for adverse event (AE) elicitation focused on long-term drug treatment in pediatric patients. Despite a lack of standardized AE elicitation methods in psychiatric clinical trials, it is clear that psychiatric medications have developmentally dependent AEs that differ from those observed in adults. In this review, we discuss the use of general inquiry elicitation, drug-specific checklists, and systematic elicitation sca...
Source: Drug Safety - January 9, 2018 Category: Drugs & Pharmacology Source Type: research

The Safety of Generic Prescription Drugs in the United States
(Source: Drug Safety)
Source: Drug Safety - January 8, 2018 Category: Drugs & Pharmacology Source Type: research

Setting Standards for Pregnancy Registries
(Source: Drug Safety)
Source: Drug Safety - December 28, 2017 Category: Drugs & Pharmacology Source Type: research

Safety of Human Papillomavirus Vaccines: An Updated Review
AbstractHuman papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and a...
Source: Drug Safety - December 26, 2017 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP ® : A Comparison with Classical Methods of Reporting
ConclusionOur study shows that a mobile app is an additional tool used in pharmacovigilance. Types of reporters and adverse drug reactions in VigiBIP were different to those seen in classical methods of reporting. (Source: Drug Safety)
Source: Drug Safety - December 21, 2017 Category: Drugs & Pharmacology Source Type: research