Public Citizen has requested that the U.S. Food and Drug Administration (FDA) warn that stent implant recipients can suffer fatal bleeding if they take the Bristol-Myers Squibb Co. and Sanofi SA blood-thinning drug Plavix for more than a year. Public Citizen said in a petition to the agency, the FDA should put its most dire warning for a drug, a so-called black box warning, on labeling for brand-name and generic versions of Plavix to alert physicians and patients to the bleeding risk. Doctors wrote more than 25 million prescriptions for Plavix and its generic form, known as clopidogrel, in the past year in the U.S., the consumer advocacy group said.
Physicians prescribe Plavix to patients after they have been implanted with a drug-eluting coronary artery stent in order to reduce the risk of a heart attack or another cardiac issue, according to Public Citizen. However, data shows that after a year of use, any benefits of taking the drug dry up, and users become more likely to suffer a major bleeding episode, Public Citizen said. In addition to a black box warning, Public Citizen wants Plavix users to receive a medication guide with information about the risks when they fill their prescription. It also wants the makers of the drug to send letters to physicians warning of the long-term use of Plavix by stent recipients.
The warning should only pertain to Plavix recipients who received a drug-eluting stent, according to Public Citizen. It should be noted that the FDA added a black box warning to the Plavix label once before, in March 2010, after it concluded that approximately 3 percent of the U.S. population cannot properly metabolize the drug. The Public Citizen petition was also signed by Dr. Neil Holtzman, a Johns Hopkins University School of Medicine emeritus professor. Dr. Holtzman’s wife died of a cerebral hemorrhage in 2011 after taking Plavix for more than two years. Dr. Holtzman said in a statement:
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.
It should be noted that Bristol-Myers Squibb and Sanofi face a number of Plavix-related personal injury suits in courts across the country, including multidistrict litigation in New Jersey. The suits accuse the companies them of failing to warn patients about the drug’s injury risks and violations of the False Claims Act stemming from alleged off-label marketing of the drug. Sanofi revealed in March that the U.S. Department of Justice was investigating the company over its disclosures to the FDA about patient responses to Plavix. But it did not make any further information available at the time. It will be interesting to see what the FDA does relating to Public Citizen’s petition.
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