Black Box Warning For Plavix

The FDA has ordered a black box warning for Plavix intended to advise healthcare practitioners of Plavix dangers in those patients who fail to metabolize the clot busting drug. This failure to metabolize may increase the risk of heart attacks and strokes in patients.
The warning is a blow to Bristol-Myers Squibb Co. and Sanofi-Aventis whose sales have topped $8 billion. The Plavix safety issue may affect 2 to 14% of Plavix users.
This is the second and more serious drug label change for Plavix. In November 2009, the FDA warned that those taking Plavix in combination with heartburn drugs such as Nexium, Prevacid, Prilosec OTC, and Protonix were 50% more likely to have a heart attack.