FDA Slaps Black Box Warning On Plavix

Law360, New York (March 15, 2010, 4:32 PM EDT) -- The U.S. Food and Drug Administration has added a black box warning to the packaging of Plavix, saying between 2 and 14 percent of the U.S. population cannot properly metabolize the blood-thinning drug and do not benefit from its use.

The heightened warning, announced Friday, comes more than a year after the agency said it was working with the drug's makers, Sanofi-Aventis SA and Bristol-Myers Squibb Co., to examine the impact of genetic factors on its efficacy.

The companies said Friday that approximately 2 percent of...
To view the full article, register now.