Public Citizen Seeks Black Box Warning on Plavix


plavix_black_box_warning_wantedPublic Citizen, a consumer watchdog group, is urging the U.S. Food and Drug Administration (FDA) to include a black box warning—the agency’s most serious—on the blood thinner, Plavix (clopidogrel), which is marketed by Bristol-Myers Squibb Co. and Sanofi SA.

Public Citizen petitioned the federal regulator to warn that patients implanted with stents may suffer deadly bleeding if they take Plavix—or its generics—for more than one year, according to Law360. More than 25 million prescriptions for Plavix and its generic versions have been written in the past year in the United States, according to Public Citizen.

Plavix is prescribed to patients following implantation with drug-eluting coronary artery stents to minimize heart attack risks and other cardiac problems, Public Citizen noted. Data reveals that one year after use, Plavix no longer offers any benefits; however, patients taking the drug are likelier to suffer a major bleeding episode, according to Public Citizen, wrote Law360.

Public Citizen also wants Plavix users to receive a mediation guide at the time a prescription is filled that explains the risks of taking Plavix and wants drug makers to warn physicians in writing of the long-term effects of taking Plavix in stent recipients, according to Law360. The warning should only apply, said Pubic Citizen, for patients who take Plavix and who received a drug-eluding stent.

Plavix already contains a black box warning after the FDA concluded that 3 percent of the U.S. population does not appropriately metabolize the blood thinner. That warning was implemented in March 2010, Law360 reported.

The recent Public Citizen petition was signed by Johns Hopkins University School of Medicine emeritus professor, Neil Holtzman. Professor Holtzman’s wife died of a cerebral hemorrhage in 2011 after having taken Plavix for more than two years, according to Law360. “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,” Holtzman said in a statement.

A recent Plavix study revealed high platelet re-activity following stenting; specifically that patients taking Plavix and aspirin experienced poor therapeutic responses. Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear the arteries of blockages.

Prior research raised some doubts about the usefulness of Plavix in preventing a recurrent stroke and a study published in The New England Journal of Medicine revealed that the Plavix-Aspirin combination is no better at preventing second strokes in people who’ve suffered a previous lacunar stroke, when compared to aspirin alone. The study also found that the addition of Plavix to an aspirin regimen also increased the likelihood of serious gastrointestinal bleeding and death.

Plavix lawsuits continue to mount. One Plavix lawsuit filed on behalf of 64 Plavix patients who alleged bleeding side effects also involved allegations that plaintiffs suffered strokes and heart attacks after taking Plavix and also alleged the drug can cause heart attacks, internal bleeding, strokes, blood disorders, or death. This is just one of a number of lawsuits filed over Plavix adverse reactions.