FDA Describes Warning to Plavix life-threatening Risks French pharmaceutical company Sanofi SA revealed that it is being investigated by the Department of Justice (DOJ) over disclosures to the U.S. Food and Drug Administration (FDA) about its blood-thinning drug, Plavix (clopidogrel).
News of the Justice Department probe was contained in Sanofi’s recent filing with the U.S. Securities and Exchange Commission (SEC), Law360 reported. The DOJ is looking into Sanofi statements to the FDA. Sanofi said that it is cooperating with DOJ officials.
Plavix, which is co-marketed by Sanofi and Bristol-Myers Squibb, is prescribed to help prevent blood clots that could lead to strokes or heart attacks, Law360 says. The FDA concluded that approximately 3 percent of the U.S. population can’t properly metabolize the drug and, therefore, it is less effective in some patients. The agency added a black box warning—its most serious—to the Plavix label in March 2010; the FDA describes this warning as “designed to call attention to serious or life-threatening risks.”
Sanofi and Bristol-Myers are accused of manipulating clinical trial
Sanofi and Bristol-Myers are accused of manipulating clinical trial data to falsely support claims Plavix was superior to cheaper drugs—in particular, aspirin, which costs 4 cents per pill against $4 per pill for Plavix, Law360 reports.
Plavix users have also filed lawsuits against the drug companies, alleging personal injury and False Claims Act violations. Nine of those suits were consolidated last month in New Jersey federal court, Law360 writes. An Illinois lawsuit brought by the U.S. alleges that the pharmaceutical companies falsely marketed Plavix to doctors as superior to cheaper medications and, as a result, government health programs paid for prescriptions they might not otherwise have approved.
Neither Sanofi nor the Department of Justice would comment on the matter, Law360 reports.