Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review

  title={Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review},
  author={Igho J. Onakpoya and Carl J. Heneghan and Jeffrey K. Aronson},
  journal={Expert Opinion on Drug Safety},
  pages={63 - 72}
ABSTRACT Introduction: Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar;; WHO databases of withdrawn products; websites of the European Medicines… 
Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017
Non-interventional studies had an important role particularly for the characterisation and quantification of adverse events, the evaluation of product usage and for evaluating the effectiveness of regulatory action to minimise risk.
Definition of hidden drug cardiotoxicity: paradigm change in cardiac safety testing and its clinical implications
The need for development of novel cardiac safety testing platform involving combined experimental models of cardiac diseases in the presence and absence of major cardiovascular comorbidities and/or cotreatments is emphasized.
Perceptions of French general practitioners and patients regarding dextropropoxyphene withdrawal: a qualitative study
Apart from physicians who were previously informed of its poor risk-benefit ratio, DXP withdrawal was not a good experience for patients and GPs, but the experience was positive for the GPs who had been alerted to the poor DXP risk- benefit ratio well before its withdrawal.
An historical overview over Pharmacovigilance
This commentary reports the milestones of pharmacovigilance up to the present day, to understand all the steps that have characterized the historical evolution; from the first reports, which were essentially letters or warnings sent by clinicians to publishers of important and famous scientific journals, up to today’s modern and ultra-structured electronic registries.
The application of omics-based human liver platforms for investigating the mechanism of drug-induced hepatotoxicity in vitro
The use of more elaborated human liver models, in harmony with causality-inferring bioinformatic approaches will pave the way for establishing a powerful methodology to systematically assess DILI mechanisms across a wide range of conditions.
Novel Electrotopological Atomic Descriptors for the Prediction of Xenobiotic Cytochrome P450 Reactions
Novel atomic descriptors to predict the sites of metabolism (SoM) in CYP substrates using Gasteiger charge are developed and obtained a gradient boosting decision tree‐based SoM classification model that performed well in terms of the Matthews correlation coefficient.
Anti-Obesity Effect of Rice Bran Extract on High-Fat Diet-Induced Obese Mice
Obesity involving adipose tissue growth and development are associated with angiogenesis and extracellular matrix remodeling. Rice bran has antioxidant and cardioprotective properties, and can act as


A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience
A systematic review of clinical trials data for three different nonsteroidal anti‐inflammatory drugs (NSAIDs) performed in an effort to identify possible early signals that could have predicted post‐marketing serious hepatoxicity.
Case reports of suspected adverse drug reactions—systematic literature survey of follow-up
Abstract Objective To determine whether anecdotal reports of suspected adverse drug reactions are valuable early warning signals. Design Systematic literature survey Data sources We evaluated all
Recent advances in the pharmacological management of acute and chronic pain.
Recent advances in the pharmacological management of pain are not so much the result of new 'miracle' drugs, but new preparations and new ways to use old drugs in a variety of settings, often as components of a multimodal approach to pain relief.
Opioids and the treatment of chronic pain: controversies, current status, and future directions.
A narrative review briefly describes the neurobiology of opioids and focuses on the complex issues at this interface between analgesia and abuse, including terminology, clinical challenges, and the potential for new agents, such as buprenorphine, to influence practice.
Three newly approved analgesics: an update.
Lower doses from different drug classes may be employed to reduce the incidence of adverse effects, while producing synergistic analgesia as part of a multimodal analgesic approach to acute pain.
New molecules for the treatment of pain
Clinical and preclinical research has progressed rapidly and this work has identified multiple plausible drug targets, which are currently being evaluated and the rationale of some of the most promising mechanisms are reviewed.
Drug safety assessment in clinical trials: methodological challenges and opportunities
The principal methodological challenges in the reporting, analysis and interpretation of safety data in clinical trials are summarized using recent examples from systematic reviews and potential solutions are discussed.
Cardiovascular Risks of Cyclooxygenase Inhibition
The pharmacologic and clinical evidence that defines the cardiovascular risk associated with COX inhibition is examined, finding that selective COX inhibitors provide more gastrointestinal protection than NSAIDs and the unbalanced inhibition of prostaglandins may promote cardiovascular complications.
The discovery and development of analgesics: new mechanisms, new modalities.
The mechanisms and modalities of analgesics that have recently entered into clinical development are reviewed, which, coupled with advances in the understanding of the pathophysiology of chronic pain, will hopefully bring the promise of new therapeutics that have the potential to provide improved pain relief for those many patients whose needs remain poorly met.
Recent patterns of medication use in the ambulatory adult population of the United States: the Slone survey.
In any given week, most US adults take at least 1 medication, and many take multiple agents; the substantial overlap between use of prescription medications and herbals/supplements raises concern about unintended interactions.