Overview: French pharmaceutical company Sanofi SA is being probed by the United States Department of Justice (DOJ) over its disclosures of the blood-thinning medication Plavix. According to the company’s annual report, the DOJ is conducting the investigation over claims made to the U.S. Food and Drug Administration (FDA). The company Is already facing a number of lawsuits over Plavix, including one filed by the West Virginia’s attorney general, alleging that it misrepresented the drug.
- Sanofi’s annual report reveals that the company is being investigated by the DOJ over disclosures made to the FDA over Plavix
- In 2010, the FDA added a blackbox warning stating that 3 percent of the population can’t properly metabolize Plavix
- Late last year, West Virginia’s attorney general filed a deceptive marketing lawsuits against the company alleging that the state had needlessly been forced to overpay for Plavix because they had falsely marketed it as superior to aspirin for certain treatments
Product: Plavix® (clopidogrel)
Manufacturer: Sanofi-Aventis, Bristol-Myers Squibb Co.
Side Effects & Complications
- Cerebral hemorrhage
- Thrombotic Thrombocytopenic Purpura (TTP)
- Gastrointestinal bleeding
- Internal bleeding
- Bone marrow damage
- Heart attack
Law360 reports that, according to a filing with the U.S. Securities and Exchange Commission on Thrusday, Sanofi is being investigated by federal officials over disclosures it made to the FDA about Plavix. The company’s annual report states that Sanofi first learned about the probe in June 2012. In March 2010, the FDA updated the Plavix label by adding a black box warning concluding that about 3 percent of the population is unable to metabolize the blood thinner. Plavix, known generically as clopidogrel, is used to prevent blood clots that can cause stroke or heart attacks. The FDA cited research showing that the drug is less effective in some patients.
A number of Plavix lawsuits allege that Sanofi mispresented Plavix by touting it as a superior version of Aspirin, a claim that is largely unsupported by research. Late last year, West Virginia’s attorney general filed a deceptive marketing lawsuit alleging that the state had been forced to overpay for the drug because Sanofi had marketed it as better than aspirin for some patients. The suit alleges that the manufacturers falsely touted the drug in order to justify a much higher cost; Plavix costs about 100 times more than Aspirin. Among other things, lawsuit also alleges that Sanofi and Bristol-Myers Squibb invested in a multimillion dollar advertising campaign promoting Plavix over Aspirin so that patients would ask their doctors for a prescription and that the company manipulated clinical studies to increase profits. Patients who took Plavix have also sued over the drug, alleging that it caused injuries such as cerebral and gastrointestinal bleeding.