Plavix (clopidogrel), the anti-clotting drug sold by Bristol-Myers Squibb and Sanofi-Aventis SA will now get the FDA's most serious black box warning, Reuters reported earlier this month. According to the FDA, the language on the drug's packaging will "warn about reduced effectiveness in patients who are poor metabolizers of Plavix."
The FDA estimates that between 2 and 14 percent of people are poor metabolizers of Plavix. Bristol Myers Squibb estimates this number to be about 3 percent, and said in a statement, "Patients should continue taking Plavix unless told to do otherwise by their healthcare professional." The warning will also advise doctors about how to identify patients who are poor metabolizers through genetic tests. The tests are expected to cost less than $500.
The FDA first expressed its concerns about Plavix, the #2 best selling drug in the world, on November 23, 1998, when it warned patients that manufacturers falsely credited the drug as being more effective than aspirin in treating heart disease. If you have taken Plavix, and suffered a stroke, heart attack, ulcers, internal bleeding or other blood disorders, contact the dangerous drug lawyers at Estey Bomberger for a free consultation of your legal rights. You may be entitled to compensation for your injuries.
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