The advocacy group Public Citizen filed a petition with the U.S. Food and Drug Administration (FDA) on Wednesday calling on the agency to add a boxed warning to the blood thinner Plavix that would alert people to the risks of major bleeding when the drug is used by patients who have received artery-opening stents.
Public Citizen says the FDA should warn doctors and patients that taking Plavix (clopidogrel) for more than a year after receiving a drug-coated stent can lead to fatal bleeding, the Associated Press (AP) reports.
Plavix is often prescribed to reduce the risk of heart attack in patients who have received stents to prop open their arteries. But Public Citizen cites clinical trials that show the drug offers no protective effect on the heart after one year and, instead, increases the risk of major – sometimes fatal – bleeding, the AP reports. According to Dr. Sidney Wolfe of Public Citizen’s Health Research Group, “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.”
The label and package insert for clopidogrel already mention the bleeding risk, but Public Citizen says this warning should be highlighted in a black box at the top of the label and on the package insert. A black box warning is the FDA’s strongest warning: it indicates that the drug carries a significant risk of serious, even life-threatening, adverse effects.
Bristol-Myers Squibb and Sanofi, the makers of Plavix, face personal injury lawsuits nationwide, including multidistrict litigation in New Jersey accusing them of failure to warn about the drug’s injury risks and violations of the False Claims Act stemming from alleged off-label marketing of the drug, Law360 reports. The U.S. Department of Justice is investigating Sanofi over disclosures to the FDA about patient responses to Plavix.
According to Public Citizen, more than 1 million drug-coated stents were implanted in the U.S. in 2012 and more than 25 million clopidogrel prescriptions were filled. The patent for Plavix expired last year and a half-dozen companies now market generic clopidogrel, according to the AP.