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
The Role of Pharmacogenomics in Rare Diseases
AbstractRare diseases have become an increasingly important public health priority due to their collective prevalence and often life-threatening nature. Incentive programs, such as theOrphan Drug Act have been introduced to increase the development of rare disease therapeutics. While the approval of these therapeutics requires supportive data from stringent pre-market studies, these data lack the ability to describe the causes of treatment response heterogeneity, leading to medications often being more harmful or less effective than predicted. If a Goal Line were to be used to describe the multifactorial continuum of pheno...
Source: Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Source Type: research
The Problems with Online Health Product Sales: How can Regulations be Improved?
AbstractWith the rapid proliferation of online businesses, national authorities are facing challenges managing the online supply of illegal health products due to the anonymity of the internet, increasing number of global syndicates, new technologies, and inability to enforce against overseas sellers. This paper describes these challenges and the Health Sciences Authority ’s regulatory approaches to tackle the online sales of illegal health products. These include partnering with platform administrators to remove illegal online postings, leveraging technological tools and relevant legislation, empowering consumers to mak...
Source: Drug Safety - March 14, 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
The Role of Pharmacogenomics in Rare Diseases
AbstractRare diseases have become an increasingly important public health priority due to their collective prevalence and often life-threatening nature. Incentive programs, such as theOrphan Drug Act have been introduced to increase the development of rare disease therapeutics. While the approval of these therapeutics requires supportive data from stringent pre-market studies, these data lack the ability to describe the causes of treatment response heterogeneity, leading to medications often being more harmful or less effective than predicted. If a Goal Line were to be used to describe the multifactorial continuum of pheno...
Source: Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Source Type: research
The Problems with Online Health Product Sales: How can Regulations be Improved?
AbstractWith the rapid proliferation of online businesses, national authorities are facing challenges managing the online supply of illegal health products due to the anonymity of the internet, increasing number of global syndicates, new technologies, and inability to enforce against overseas sellers. This paper describes these challenges and the Health Sciences Authority ’s regulatory approaches to tackle the online sales of illegal health products. These include partnering with platform administrators to remove illegal online postings, leveraging technological tools and relevant legislation, empowering consumers to mak...
Source: Drug Safety - March 14, 2024 Category: Drugs & Pharmacology Source Type: research
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
ConclusionsThe RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science. (Source: Drug Safety)
Source: Drug Safety - March 13, 2024 Category: Drugs & Pharmacology Source Type: research
Drug –Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation
ConclusionAlthough most patients experienced a pDDI during their hospital stay, less than one-third of pDDIs were clinically relevant. The low prevalence of harm identified raises questions about the value of incorporating DDI decision support into systems given the potential negative impacts of DDI alerts. (Source: Drug Safety)
Source: Drug Safety - March 13, 2024 Category: Drugs & Pharmacology Source Type: research
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
ConclusionsThe RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science. (Source: Drug Safety)
Source: Drug Safety - March 13, 2024 Category: Drugs & Pharmacology Source Type: research
Drug –Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation
ConclusionAlthough most patients experienced a pDDI during their hospital stay, less than one-third of pDDIs were clinically relevant. The low prevalence of harm identified raises questions about the value of incorporating DDI decision support into systems given the potential negative impacts of DDI alerts. (Source: Drug Safety)
Source: Drug Safety - March 13, 2024 Category: Drugs & Pharmacology Source Type: research
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease
ConclusionsIn our cohort with suspected DI-ILD, 79% carried one or more genetic variants accompanied by the use of drugs metabolized by a corresponding affected pathway. In 60%, the diagnosis of DI-ILD was likely, whereas in 37.5%, it was highly likely, based on CYP analyses. This study underlines the importance of considering both drug use and genetic make-up as a possible cause, or at least a contributing factor, in the development and/or progression of fibrotic lung diseases.Clinical Trial RegistrationClinicalTrials.gov identifier NCT00267800, registered in 2005. (Source: Drug Safety)
Source: Drug Safety - March 9, 2024 Category: Drugs & Pharmacology Source Type: research
Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making
ConclusionsSocial media display considerable potential as a source of RWD for guiding efforts in pharmaceutical drug development and pre-approval settings. Although further regulatory guidance on the use of social media for RWD is needed to encourage its use, regulatory and technological developments are suggested to warrant at least exploratory uses for drug development. (Source: Drug Safety)
Source: Drug Safety - March 6, 2024 Category: Drugs & Pharmacology Source Type: research
