Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval.
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.
Borer
Jeffrey S
JS
Division of Cardiovascular Pathophysiology, Weill Medical College of Cornell University, 47 East 88th Street, New York, NY 10128-1152, USA.
Pouleur
Hubert
H
Abadie
Eric
E
Follath
Ferrenc
F
Wittes
Janet
J
Pfeffer
Marc A
MA
Pitt
Bertram
B
Zannad
Faiez
F
D002318:Cardiovascular Diseases / Q000503:physiopathology*; D017277:Drug Approval; D011307:Drug Prescriptions; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration