Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies.

ABSTRACT: Information on rare adverse effects is often limited when a medication is initially approved for marketing. Medicines regulators use safety advisories to warn health professionals and consumers about emerging harms. This study aimed to identify characteristics and advice provided in cardiac safety advisories released by regulators in Australia, Canada, the United Kingdom, and the United States. This was a retrospective study of safety advisories about cardiac-related adverse events issued by these four international medicines regulators between 2010 and 2016. A descriptive overview was followed by a more detailed content analysis, focusing on recommended actions for health professionals, including monitoring advice. For the latter, we applied the systematic information for monitoring (SIM)

SUBMITTER: Hooimeyer A 

PROVIDER: S-EPMC7652786 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature