Clinical Edge

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FDA Issues Safety Caution on Plavix

Says long-term use does not change risk of death

An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. After conducting an evaluation of the Dual Antiplatelet Therapy (DAPT) trial along with several other clinical trials, the FDA concluded that clopidogrel also does not increase the risk of cancer or death from cancer. The FDA recommends that healthcare professionals consider the benefits and risks of available antiplatelet medicines before starting treatment and may report any adverse events or side effects related to the use of clopidogrel to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Citation: U.S. Food and Drug Administration. Plavix (clopidogrel): Drug Safety Communication – Long-term treatment does not change risk of death. FDA Web site. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm471531.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 9, 2015.