COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance
ConclusionsConsumer reporting to the European Union spontaneous data collection system, EudraVigilance, was of high value for regulatory safety reviews, albeit the reporting behaviours were not free of the influence of the media. These sources of information can be investigated to understand the context of safety concerns of public health interest. (Source: Drug Safety)
Source: Drug Safety - April 12, 2024 Category: Drugs & Pharmacology Source Type: research
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy
AbstractEnzalutamide is an oral androgen receptor signaling inhibitor utilized in the treatment of men with prostate cancer. It is a moderate inducer of the cytochrome P450 (CYP) enzymes CYP2C9 and CYP2C19, and a strong inducer of CYP3A4. It was also shown to be a mild inhibitor of the efflux transporter P-glycoprotein in patients with prostate cancer. Enzalutamide is primarily metabolized by CYP3A4 and CYP2C8. The risk of enzalutamide drug interactions arises primarily when it is coadministered with other drugs that interact with these CYPs, including CYP3A4. In this review, we begin by providing an overview of enzalutami...
Source: Drug Safety - April 12, 2024 Category: Drugs & Pharmacology Source Type: research
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
AbstractAdditional risk minimization strategies may be required to assure a positive benefit –risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (H CPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnan...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination
AbstractDuring the COVID-19 vaccination campaign, observed-to-expected analysis was used by the European Medicines Agency to contextualise data from spontaneous reports to generate real-time evidence on emerging safety concerns that may impact the benefit-risk profile of COVID-19 vaccines. Observed-to-expected analysis compares the number of cases spontaneously reported for an event of interest after vaccination ( ‘observed’) to the ‘expected’ number of cases anticipated to occur in the same number of individuals had they not been vaccinated. Observed-to-expected analysis is a robust methodology that relies on seve...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
AbstractAdditional risk minimization strategies may be required to assure a positive benefit –risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (H CPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnan...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination
AbstractDuring the COVID-19 vaccination campaign, observed-to-expected analysis was used by the European Medicines Agency to contextualise data from spontaneous reports to generate real-time evidence on emerging safety concerns that may impact the benefit-risk profile of COVID-19 vaccines. Observed-to-expected analysis compares the number of cases spontaneously reported for an event of interest after vaccination ( ‘observed’) to the ‘expected’ number of cases anticipated to occur in the same number of individuals had they not been vaccinated. Observed-to-expected analysis is a robust methodology that relies on seve...
Source: Drug Safety - April 9, 2024 Category: Drugs & Pharmacology Source Type: research
Fatal Intoxications with Zopiclone —A Cause for Concern?
ConclusionThis study demonstrates that the toxicity of zopiclone can be lethal both in combination with other substances and on its own. Most individuals dying in fatal zopiclone intoxications were prescribed zopiclone, which potentially indicates that a more restrictive prescribing rate could prevent future intoxication deaths, especially when caring for patients with an increased suicide risk. (Source: Drug Safety)
Source: Drug Safety - March 27, 2024 Category: Drugs & Pharmacology Source Type: research
Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea
ConclusionsWe found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. Our findings emphasize the utility of real-world evidence in advancing our understanding of adverse drug reactions in clinical practice. (Source: Drug Safety)
Source: Drug Safety - March 21, 2024 Category: Drugs & Pharmacology Source Type: research
Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis
(Source: Drug Safety)
Source: Drug Safety - March 18, 2024 Category: Drugs & Pharmacology Source Type: research
The Role of Mitochondria in Statin-Induced Myopathy
AbstractStatins represent the primary therapy for combatting hypercholesterolemia and reducing mortality from cardiovascular events. Despite their pleiotropic effects in lowering cholesterol synthesis, circulating cholesterol, as well as reducing the risk of other systemic diseases, statins have adverse events in a small, but significant, population of treated patients. The most prominent of these adverse effects is statin-induced myopathy, which lacks precise definition but is characterised by elevations in the muscle enzyme creatine kinase alongside musculoskeletal complaints, including pain, weakness and fatigue. The ex...
Source: Drug Safety - March 16, 2024 Category: Drugs & Pharmacology Source Type: research
An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014 –2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older
ConclusionNo safety concerns were found during this surveillance study of IIV4 in subjects aged ≥ 6 months in Korea. The findings of this study suggest IIV4 is safe and well tolerated for use in all age groups with a vaccine indication.Graphical Abstract (Source: Drug Safety)
Source: Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Source Type: research
