Safety Alerts & Recalls
What does this mean?
The FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.
If you take clopidogrel (Plavix) or prasugrel (Effient), please continue to take your medicine as prescribed by your healthcare provider. You should not stop taking your medicine because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major heart problems.
If you have any concerns about this alert or your medicine, please speak to your healthcare provider who can address your concerns as related to your medical history.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: http://www.fda.gov/Safety/MedWatch/default.htm
FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient)
The US Food and Drug Administration (FDA) is reviewing data from a clinical research study called the Dual Antiplatelet Therapy (DAPT) study comparing the benefits and risks of 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.
The DAPT study, published in the New England Journal of Medicine on November 16, 2014, reported that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared with 12 months of treatment. The higher rate of death can be explained by an increase in deaths from non–heart-related causes, primarily cancer and trauma deaths. The increased risk of death with longer treatment was seen in the patients given clopidogrel, but not in those given prasugrel. Increases in non–heart-related death have not been reported in previous large studies examining clopidogrel for other heart-related diseases.
At this time, the FDA is evaluating the study results and has not reached any conclusions based on the findings from this clinical study. The FDA will communicate their final conclusions and recommendations when their evaluation is complete.
For more information, please visit: more information here