Safety Alerts & Recalls

What does this mean?

If you take clopidogrel (Plavix), 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 to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

FDA Completes Review of Blood-Thinning Medicine Plavix (Clopidogrel)

The U.S. Food and Drug Administration (FDA) has completed its recent review of Plavix (clopidogrel). In order to investigate the increased risk of death and cancer-related death reported with clopidogrel in the Dual Antiplatelet Therapy (DAPT) trial published in November of 2014, the FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on these risks.

The FDA review determined that long-term use of the antiplatelet drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. The FDA evaluation did not suggest that clopidogrel increases the risk of cancer or death from cancer.

Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots.

For more information, please visit: more information here

Source: FDA
Publication Date: 2015-11-12
Last Updated: 2015-11-13

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