Plavix drug maker, Sanofi SA, is being probed by federal officials over its disclosures to the U.S. Food & Drug Administration (FDA) concerning the blood thinner. Plavix is co-marketed with Bristol-Myers Squibb Co.
According to a just-released filing Sanofi made to the U.S. Securities and Exchange Commission (SEC), the U.S. Department of Justice (DOJ) is probing Sanofi’s statements to the U.S Food and Drug Administration (FDA) concerning patient reports over Plavix (clopidogrel), said Law360. In its annual report, Sanofi said that the DOJ is probing statements it made to the federal regulator. Sanofi said it first learned of the probe in June 2012, Law360 noted.
Plavix, an anti-platelet medication approved in the United States in 1997, is prescribed to reduce risks of atherosclerotic events such as blood clot, stroke, and heart attack in patients with a history of these conditions. Plavix has generated about $42.8 billion in sales since its approval.
We previously wrote that recent research raised some doubts about the usefulness of Plavix in preventing a recurrent stroke. The study, previously published in The New England Journal of Medicine, found that the combination of Plavix and aspirin is no better at preventing second strokes in people who’ve suffered a previous lacunar stroke, when compared to aspirin alone. The addition of Plavix to an aspirin regimen also increased the likelihood of serious gastrointestinal bleeding and death, according to the study.
Meanwhile, Plavix lawsuits continue to mount. In fact, we previously wrote that one Plavix lawsuit was filed on behalf of 64 Plavix patients who allege bleeding side effects. That group claims it suffered strokes and heart attacks after taking Plavix and alleges 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.
The national law firm Parker Waichman LLP, has filed a number of lawsuits on behalf of patients over Plavix injuries and allegations that the blood thinner caused adverse reactions such as multiple stomach bleeds, gastrointestinal hemorrhage, cerebral hemorrhage, and the blood condition TTP. Lawsuits claim that the drug makers knew Plavix increased risks of serious bleeding events, yet continued to sell the drug to protect their financial interests and that the drug makers made false and unsubstantiated claims when marketing Plavix by touting its superiority to aspirin in lowering the rate of blood clots, stroke, and heart attack.
The West Virginia attorney general also brought a deceptive marketing lawsuit against Sanofi and Bristol-Myers late last year after the state was forced to overpay for an unnecessary drug. According to the allegations, the drug firms deceptively marketed Plavix as superior to aspirin for specific treatments, said Law360, citing the complaint. According to the lawsuit, the firms allegedly touted Plavix to physicians to justify its higher price, which cost about 100 times more than the price for aspirin, which drove profits, said Law360.
In addition to personal injury allegations, Plavix users have also filed lawsuits alleging False Claims Act violations; nine such suits were just consolidated in New Jersey federal court and 12 similar complaints are pending consolidation in California and Mississippi, Law360 explained.
Meanwhile, in 2010, the U.S. Food and Drug Administration (FDA) added a black box warning to the Plavix label after it found that about three percent of the U.S. population is unable to properly metabolize the drug. The agency cited research that suggest that clopidogrel, which is sold as the brand Plavix, is less efficacious in some patients because of the way in which Plavix must be metabolized, said Law360.