Photo: Trounce
The U.S. Food and Drug Administration should warn patients
and doctors that taking the widely prescribed drug Plavix or clopidogrel for
more than a year after having a drug-eluting stent implanted can lead to major
bleeding, which can kill, Public Citizen said in a petition to the agency.
Public Citizen, a consumer advocacy organization, is urging
the agency to issue a black box warning on Plavix. It sent the petition jointly
with Neil A. Holtzman, M.D., 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.
“The research shows that using this drug for more than 12 months puts people at
risk of potentially life-threatening bleeding, without any evidence that it’s
doing any good at that point,” said Sidney Wolfe, M.D., founder and senior
adviser to Public Citizen’s Health Research Group. “The FDA should promptly
warn against prolonged use on the product’s labeling, require a warning in
patient medication guides, and ask the manufacturers to send a letter warning
physicians.”
In 2012, more than one million drug-eluting stents were placed in coronary
arteries in the United States, making up 80 percent of all stents implanted
following angioplasty. In the last year for which data are available, through
June 2013, 25.5 million prescriptions for clopidogrel were written in the U.S.
The petition also calls on the FDA to require the distribution of an
FDA-approved, updated medication guide containing this information to be
dispensed to all patients when their prescriptions are filled and to ask
companies to send a “Dear Doctor” letter to warn physicians of these
preventable adverse effects that occur with use for greater than one year.
