FDA Mandates New Plavix Warning Label
On March 12, 2010, the FDA added a black-box warning to the label of the anti–blood clotting medicine Plavix, alerting physicians and patients that the drug could be less effective in people who cannot metabolize the pill properly, putting them at a high risk of heart attack and stroke.
Plavix is taken by patients to reduce the risk of heart failure, unstable angina and stroke. The drug works by making platelets that are less likely to form blood clots, but its anti-platelet effect occurs only after it is metabolized by a specific liver enzyme.
According to the FDA about 2 to 14 percent of individuals do not have a sufficient amount of this specific liver enzyme and are therefore unable to process Plavix into its active form.
The FDA had revised the drug’s labeling previously to reflect its concern for some patients, but the new warning will appear within a black box. It is considered the agency’s strongest warning label.
Plavix is a big money-maker for Bristol-Myers Squibb and Sanofi-Aventis. In 2008, the drug generated $8.6 billion in worldwide sales. The manufacturers are, however, cooperating with the FDA and have announced that new Plavix labels will be issued within two months.
Patients should not stop taking Plavix before consulting their health care provider. A genetic test can help identify patients who may not be good candidates for Plavix.
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