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Summary Box: FDA puts black box warning on Plavix

Fri, 03/12/2010 - 10:17am
The Associated Press

PLAVIX PROBLEM: The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner.

GENETIC CAUSE: A small percentage of people have a genetic variation that prevents them from making an enzyme needed to break down Plavix.

BLOCKBUSTER: Plavix is marketed by Sanofi-Aventis and Bristol-Myers Squibb. With global sales of $8.6 billion in 2008, it was the world's second-best selling drug. Experts say the new FDA warning could push more doctors to prescribe Effient, a competing blood thinner launched by Eli Lilly last summer.

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