Plavix May Cause Recurrent Ulcers, Study Shows

The safety of antistroke drug Plavix -- one of the world's top-selling brands -- was called into question recently following the release of new clinical research that shows the drug might cause a high rate of recurrent ulcers.

The study, published in The New England Journal of Medicine, found that patients taking Plavix (clopidogrel) experienced more than 12 times as many ulcers as patients taking aspirin and esomeprazole, a heartburn pill. The study was led by Francis Chan of the Chinese University of Hong Kong.

The study results were particularly noteworthy because Plavix, which is co-marketed by Bristol-Myers Squibb and sanofi-aventis, is said by medical groups to be easier on the stomach than aspirin, which is known to cause stomach problems, including ulcers, in some patients. Plavix and aspirin are commonly used by heart and stroke patients to reduce the risk of blood clotting. Both the American Heart Association and the American College of Cardiology recommend that patients who are prone to gastrointestinal problems take Plavix instead of aspirin.

Plavix's apparent advantages have helped carve a huge market for the drug, which pulled in a whopping $2.8 billion in sales during the first half of 2004.

In Chan's study, 320 patients with healed ulcers were randomly assigned to two groups -- one taking 75 mg of Plavix daily and the other taking 80 mg of aspirin daily plus 20 mg of esomeprazole twice daily for 12 months. Recurrent ulcer bleeding occurred in 13 patients receiving clopidogrel and one receiving aspirin plus esomeprazole.

To view an abstract of the study, go to http://content.nejm.org/cgi/content/short/352/3/238 (http://content.nejm.org/cgi/content/short/352/3/238).