Healthy Skepticism Library item: 12389

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Borer JS, Pouleur H, Abadie E, Follath F, Wittes J, Pfeffer MA, Pitt B, Zannad F.
Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval.
Eur Heart J 2007 Aug; 28:(15):1904-9
http://www.ncbi.nlm.nih.gov/pubmed/17615083

Abstract:

Recently, several drugs for non-cardiovascular diseases have ceased marketing because of cardiovascular risk, highlighting the importance of evaluating the cardiovascular safety of new drugs even if not intended for cardiovascular diseases. Assessing and ensuring acceptable cardiovascular safety of non-cardiovascular drugs is difficult; nonetheless, governmental regulatory agencies are likely to change the requirements for drug safety information. This article explores our recommendations for rethinking current regulatory policies, emphasizing the need for mandatory post-marketing surveillance registries and highlighting the exposures necessary to subserve the need for greater assessment of safety issues.

Keywords:
Cardiovascular Diseases/physiopathology* Drug Approval Drug Toxicity* Humans Pharmaceutical Preparations/adverse effects* Prescriptions, Drug* Product Surveillance, Postmarketing Risk Assessment Risk Factors United States United States Food and Drug Administration