Consumer watchdog group Public Citizen is lobbying federal drug regulators to place a black box warning on the anticoagulant Plavix notifying that patients with drug-delivering coronary artery stents could die from a major bleeding event if they take the medication for more than a year. A black box warning is the strongest warning placed on prescription medication and is given to products that, based on medical studies, pose a serious or life threatening risk for adverse events.
More than 25 million prescriptions for Plavix, and its generic equivalent clopidogrel, were written during the past year. The blood thinner is used alone or with aspirin to help prevent strokes and heart attacks. Public Citizen argues that data shows patients with drug-eluting coronary artery stents who take Plavix for a year become more likely to suffer a major bleeding event. The group not only wants the strongest type of warning placed on the drugs but also wants patients to receive medication guides that outline the risk when they fill prescriptions, and letters sent to physicians to warn them of the long-term risks with using Plavix on patients with stents.
Plavix already carries a boxed warning that says 3 percent of the U.S. population cannot properly metabolize the drug, which can result in life threatening consequences.
Bristol Myers-Squibb and Sanofi make brand name and generic versions of Plavix. The companies currently face Plavix lawsuits regarding failing to warn users of potential injuries associated with the drug and for violations of the False Claims Act for allegedly marketing the drug for uses for which it has not received FDA approval.
Source: Law 360