The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
We describe the role of the European Medicines Agency alongside the EU regulatory network in the safety monitoring of the COVID-19 vaccines, and provide an insight into challenges, particularities and outcomes of the scientific assessment and regulatory decisions in the complex, dynamic international environment of the pandemic. We discuss the flexible procedural tools that were used to ensure an expedited scientific assessment of safety issues, and subsequent updates of the product information (i.e., labelling) when available evidence (e.g., spontaneous reports, findings from observational studies and/or scientific litera...
Source: Drug Safety - February 23, 2024 Category: Drugs & Pharmacology Source Type: research
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
AbstractMedical science has often used adult males as the standard to establish pathological conditions, their transitions, diagnostic methods, and treatment methods. However, it has recently become clear that sex differences exist in how risk factors contribute to the same disease, and these differences also exist in the efficacy of the same drug. Furthermore, the elderly and children have lower metabolic functions than adult males, and the results of clinical trials on adult males cannot be directly applied to these patients. Spontaneous reporting systems have become an important source of information for safety assessme...
Source: Drug Safety - February 22, 2024 Category: Drugs & Pharmacology Source Type: research
Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
(Source: Drug Safety)
Source: Drug Safety - February 17, 2024 Category: Drugs & Pharmacology Source Type: research
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
ConclusionsObserved variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing emerging drug safety concerns among more vulnerable populations. (Source: Drug Safety)
Source: Drug Safety - February 14, 2024 Category: Drugs & Pharmacology Source Type: research
Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy
AbstractHepatitis B virus reactivation (HBVr) during and after immunosuppressive/immunomodulatory (IS/IM) therapy is associated with significant morbidity and mortality, including hepatic decompensation and acute liver failure. The risk of HBVr with IS/IM has been heterogeneous and often unpredictable. As a result, patients with active or previous HBV infection are often excluded from clinical drug trials of such agents. Thorough screening for HBV infection, antiviral prophylaxis, and careful monitoring for HBVr have proven to be effective in reducing the rate of HBVr and improving its outcome in the context of IS/IM. Ther...
Source: Drug Safety - February 14, 2024 Category: Drugs & Pharmacology Source Type: research
Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review
AbstractTacrolimus, a calcineurin inhibitor, is an immunosuppressant used globally to prevent rejection after organ transplantation. Although it significantly improves outcomes for solid organ transplant patients, it is associated with various side effects such as nephrotoxicity and neurotoxicity. Tacrolimus-induced neurotoxicity is frequently encountered in clinical practice and can present with a variety of symptoms that may occur even at therapeutic levels. Although tacrolimus-induced neurotoxicity is well documented, there is limited literature available on pharmacologic management. Twenty-eight case reports of tacroli...
Source: Drug Safety - February 14, 2024 Category: Drugs & Pharmacology Source Type: research
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
ConclusionsObserved variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing emerging drug safety concerns among more vulnerable populations. (Source: Drug Safety)
Source: Drug Safety - February 14, 2024 Category: Drugs & Pharmacology Source Type: research
Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy
AbstractHepatitis B virus reactivation (HBVr) during and after immunosuppressive/immunomodulatory (IS/IM) therapy is associated with significant morbidity and mortality, including hepatic decompensation and acute liver failure. The risk of HBVr with IS/IM has been heterogeneous and often unpredictable. As a result, patients with active or previous HBV infection are often excluded from clinical drug trials of such agents. Thorough screening for HBV infection, antiviral prophylaxis, and careful monitoring for HBVr have proven to be effective in reducing the rate of HBVr and improving its outcome in the context of IS/IM. Ther...
Source: Drug Safety - February 14, 2024 Category: Drugs & Pharmacology Source Type: research
Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review
AbstractTacrolimus, a calcineurin inhibitor, is an immunosuppressant used globally to prevent rejection after organ transplantation. Although it significantly improves outcomes for solid organ transplant patients, it is associated with various side effects such as nephrotoxicity and neurotoxicity. Tacrolimus-induced neurotoxicity is frequently encountered in clinical practice and can present with a variety of symptoms that may occur even at therapeutic levels. Although tacrolimus-induced neurotoxicity is well documented, there is limited literature available on pharmacologic management. Twenty-eight case reports of tacroli...
Source: Drug Safety - February 14, 2024 Category: Drugs & Pharmacology Source Type: research
Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis
ConclusionsA higher risk of drug-related PML in patients whose immune system is not additionally depressed by means of neoplasms, HIV or concomitant medications is found in the neurological field. This risk is higher in MS treatment, and specifically during long-term natalizumab therapy. While this drug is still routinely prescribed in this field, considering the efficacy in reducing MS relapses, in other areas it could play a smaller role, and be gradually replaced by other safer and more recently approved agents. (Source: Drug Safety)
Source: Drug Safety - February 7, 2024 Category: Drugs & Pharmacology Source Type: research
Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
ConclusionDifficulties finding and using information from clinical guidelines contribute to thousands of prescribing and medication administration incidents, some of which are associated with substantial patient harm. (Source: Drug Safety)
Source: Drug Safety - February 2, 2024 Category: Drugs & Pharmacology Source Type: research
