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Evidence Behind FDA Alerts for Drugs with Adverse Cardiovascular Effects: Implications for Clinical Practice
Author(s) -
Rackham Daniel M.,
C. Herink Megan,
Stevens Ian G.,
Cardoza Natalie M.,
Singh Harleen
Publication year - 2014
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/phar.1381
Subject(s) - medicine , discontinuation , adverse effect , postmarketing surveillance , clinical trial , intensive care medicine , patient safety , clinical practice , drug , health care , warning system , medical emergency , pharmacology , family medicine , aerospace engineering , engineering , economics , economic growth
The U.S. F ood and D rug Administration ( FDA ) periodically publishes D rug S afety C ommunications and D rug A lerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long‐term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular ( CV ) safety announcements have been released for FDA ‐approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high‐risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications.