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Aug. 21, 2013

Plavix Use Beyond One Year After Stent Implantation Brings Significant Dangers but No Benefit; FDA Should Warn Against Drug’s Prolonged Use

Public Citizen and Husband of Victim Petition FDA for Black Box Warning

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should warn patients and doctors that taking the widely prescribed drug Plavix (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 today.

Public Citizen, which is urging the agency to issue a black box warning on Plavix, researched and sent the petition jointly with Dr. Neil A. 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.

Clopidogrel is given to patients after a drug-eluting coronary artery stent (DES) is implanted, usually after a heart attack, to reduce future such events. But it should be given no more than 12 months after implantation, Public Citizen said today. The petition cites evidence from randomized controlled trials and other studies indicating that taking clopidogrel for longer than a year following the implantation of a DES offers no further benefit, in terms of reduced death from cardiac causes, myocardial infarction or other thrombotic events, compared to taking it for a year or less. It does, however, increase the likelihood of major bleeding, which may be fatal. The requested warnings apply only to people using the drug in conjunction with a DES.

“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 Dr. Sidney Wolfe, 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 1 million drug-eluting stents were placed in coronary arteries in the United States, comprising 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 United States.

Holtzman’s involvement in the petition results from the death of his wife, Dr. Barbara Starfield, at age 78. Starfield began taking Plavix immediately following angioplasty and insertion of a drug-eluting coronary artery stent in January 2009. Her cardiologist continued the drug for almost two and a half years until her death in June 2011 from an acute, massive cerebral hemorrhage.

“The doctor didn’t know, and we didn’t know, that this drug that had significant risks was providing no additional benefit at that point,” Holtzman said. “It’s absurd that doctors are now still prescribing and people are still taking this drug for more than a year after a stent when it turns out the research shows this is putting people at serious risk unnecessarily.”

In the petition, Public Citizen and Holtzman call on the FDA to add a black box warning on the product, the highest form of warning on a pharmaceutical product. The petition calls for the following text for the label:

“The continuation of clopidogrel for longer than 12 months following percutaneous insertion of a drug-eluting stent is of questionable additional benefit in preventing adverse cardiac events but continues to carry an increased risk of major and minor bleeding, even in those who have no known bleeding tendency.”

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.

The petition is available at: http://www.citizen.org/hrg2149


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