Generic Plavix on the Way

U.S. Food and Drug Administration officials today approved generic versions of blockbuster blood thinner Plavix (clopidogrel bisulfate).

Plavix ranks second among the top U.S. pharmaceutical products by spending, raking in $6.8 billion in 2011 and $6.1 billion in 2010, according to IMS Health.

Discuss the benefits and risks of blood thinners with your doctor before beginning treatment.

The drug reduces the risk of heart attack and stroke by lowering the chance that platelets in the blood clump and form blood clots in the arteries.

Clopidogrel is approved for treating patients who have suffered a recent heart attack or stroke, or who suffer from peripheral artery disease, which causes blood clots in the legs.

Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, noted that effective and affordable treatment is important for patients with chronic health conditions. He said the approved generic products will expand options for these patients.

Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals were approved by the FDA to produce 300 milligram clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals were approved for 75 milligram clopidogrel.

The drug carries boxed warnings that the medication may not be as effective for patients with certain genetic factors that affect how the body metabolizes clopidogrel.

Doctors can test for those genetic factors prior to prescribing the medication.

Certain drugs, including proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), also can reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke.

Clopidogrel may cause bleeding that can be serious and could lead to death. Patients also may bruise more easily and be prone to nose bleeds while taking clopidogrel.