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FDA NEWS RELEASE For Immediate Release: March 12, 2010 Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA Announces New Boxed Warning on Plavix Alerts patients, health care professionals to potential for reduced effectiveness The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making...

Contact: Alisa Zapp Machalekalisa.machalek@nih.gov 301-496-7301NIH/National Institute of General Medical Sciences Gene variant linked to risk of stroke and heart attack for those on Plavix NIGMS media availability WHAT: A new study reports that a gene variant carried by about a third of the population plays a major role in this group's response to an anti-clotting medicine, clopidogrel (Plavix). People with the variant produce a defective version of the CYP2C19 enzyme and are less able to activate the drug.One of the world's best-selling medicines, Plavix prevents blood clots in people with heart disease by keeping platelets from sticking together. But about...

The Associated Press STOCKHOLM, Sweden — Giving heart-attack patients a dose of "superaspirin" before rather than during a procedure to restore blood flow to the heart could save tens of thousands of lives a year, new research suggests. In a major international study presented yesterday at a meeting of the European Society of Cardiology, scientists found that giving heart-attack victims the drug Plavix when they arrive at the emergency room almost halved the risk of a stroke, a repeated heart attack or death within the first month after angioplasty. Angioplasty, a procedure where doctors thread a needle through the blood...

By THE ASSOCIATED PRESS ORLANDO, Fla., March 9 (AP) - Adding Plavix to other anticlotting drugs typically given to heart attack patients saves lives and prevents second heart attacks, two international studies have found. The strategy, specialists said, is the first big advance in care after heart attacks in more than 10 years, since the efficacy of modern clot-busters was shown. The low-cost and simple treatment of using Plavix will have major effects in community hospitals, where most Americans obtain care, the scientists said. It could also help in poorer countries, where heart surgery and the opening of blocked arteries...

Patients taking Plavix, a popular and expensive antistroke drug, experience more than 12 times as many ulcers as patients who take aspirin plus a heartburn pill, a study to be published today in The New England Journal of Medicine found. Up to half of those now taking Plavix do so because their doctors assume that Plavix is safer on the stomach than aspirin, said Dr. Francis K. L. Chan, the study's lead author. Both the American College of Cardiology and the American Heart Association recommend that heart and stroke patients at risk of developing ulcers be given Plavix instead of...