FDA Approves Generic Versions of Plavix

THURSDAY May 17, 2012 -- The U.S. Food and Drug Administration on Thursday approved generic versions of the blood thinner Plavix (clopidogrel), making the widely used medication more affordable for those patients who need it.

"For people who must manage chronic health conditions, having effective and affordable treatment options is important. The generic products approved today will expand those options for patients," Keith Webber, deputy director of the Office of Pharmaceutical Sciences in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

A cardiology expert applauded the move.

Adherence rates will improve as a result of the lower-priced generic versions, and fewer patients will suffer from preventable cardiovascular problems, said Dr. Gregg Fonarow, director of the Ahmanson-UCLA Cardiomyopathy Center in Los Angeles.

"This medication has helped millions of patients avoid fatal and nonfatal cardiovascular events," said Fonarow, who also is a spokesman for the American Heart Association. But its high cost has "contributed to patients not filling initial prescriptions for the drug and premature discontinuation of clopidogrel," he said.

Patients who stop taking the drug prematurely may face catastrophic consequences, including fatal cardiovascular events and strokes, he added.

Sales of Plavix, made by Bristol-Myers Squibb, topped $9 billion in 2011. A generic version, at a much lower cost, is expected to eat into those sales dramatically. The drug already is sold as a generic by Sanofi in much of the European Union, according to the Associated Press.

The cost of Plavix was almost $200 a month, according to published reports. The generic versions are expected to cost much less.

Clopidogrel works by helping prevent platelets in the blood from sticking together to form clots. The drug usually is taken along with aspirin, which acts as a blood thinner to prevent heart attack and stroke.

Clopidogrel is commonly used by patients with heart-related chest pain, unstable heart disease or those who have had a stent implanted to open a blocked artery.

Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals won FDA approval Thursday for their generic versions of 300 milligram (mg) Plavix.

Apotex Corp., Aurobindo Pharma, Roxane Laboratories, Sun Pharma, Torrent Pharmaceuticals, Mylan and Teva won approval for lower-dose versions (75 mg), the FDA added.

"The most important impact of the availability of generics will be to reduce costs for patients and health systems where clopidogrel is already indicated," said Dr. Ralph Sacco, chairman of neurology at the University of Miami School of Medicine and former president of the American Heart Association.

The drug doesn't work for everyone, however. Some patients can't metabolize it, which reduces its effectiveness.

In addition, new drugs are available that may be better than clopidogrel, Fonarow said.

"Newer antiplatelet agents, such as prasugrel [Effient] and ticagrelor [Brilinta], have been shown to be more effective] than clopidogrel, and for many patients these [drugs] may be a better choice, despite higher cost," Sacco said.

Plavix, even in a less expensive version, can't replace other clot-preventing drugs, such as warfarin, in certain patients.

For example, Plavix is not recommended for patients with an irregular heartbeat, called atrial fibrillation, who take blood thinners to prevent strokes. A 2009 report in the New England Journal of Medicine said patients with atrial fibrillation who took Plavix were at an unacceptably high increased risk of severe bleeding.

More information

For more information on clopidogrel, visit the U.S. National Institutes of Health.

Posted: May 2012


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