FDA should warn against prolonged use of Plavix for stent patients, says US consumer group

The US Food and Drug Administration should warn patients and doctors that taking the widely prescribed drug Plavix (clopidogrel), the now off-patent blockbuster anti-platelet agent from French drug major Sanofi (Euronext: SAN), for more than a year after having a drug-eluting stent implanted can lead to major bleeding, which can kill, US consumer health advocacy Public Citizen said in a petition to the agency.

Public Citizen, which is urging the agency to issue a black box warning on Plavix, researched and sent the petition jointly with Neil Holtzman, whose wife died in 2011 after taking the drug for nearly two and a half years following implantation of a stent. Plavix is marketed by Bristol-Myers Squibb and Sanofi, as well as generic manufacturers.

Requested warning apply only to DES patients