DOJ Investigating Sanofi over Plavix Disclosures

DOJ Investigating Sanofi over Plavix DisclosuresOverview: 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
  •       Ulcers
  •       Internal bleeding
  •       Bone marrow damage
  •       Heart attack
  •       Stroke
  •       Death

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Study Says Plavix-Aspirin Combo Not Helpful for Preventing Second Stroke

Study Says Plavix-Aspirin Combo Not Helpful for Preventing Second StrokeOverview: For patients with a history of stroke, taking Plavix with aspirin is not more effective than taking aspirin alone, according to a new study. In fact, data indicates that the combination can actually raise the risk of major bleeding and death. The new study, which was published in the New England Journal of Medicine (NEJM) only fuels lawsuits alleging that Plavix is defective and causes hemorrhaging.

 

 

  • NEJM study says that taking dual therapy with aspirin and Plavix in patients who have had a lacunar stroke is not more effective than aspirin alone for preventing a second stroke
  • Compared to the group that took only aspirin, the Plavix plus aspirin group had twice the rate of major hemorrhaging events and a higher incidence of death
  • The latest findings support previous research showing that Plavix with aspirin is not more effective than aspirin alone; Plavix is also associated with an increased risk of hemorrhaging

Product: Plavix (clopidogrel)  

Manufacturer: Sanofi-Aventis, Bristol-Myers Squibb Co.

Side Effects & Complications 

  •       Cerebral hemorrhage
  •       Thrombotic Thrombocytopenic Purpura (TTP)
  •       Gastrointestinal bleeding
  •       Ulcers
  •       Internal bleeding
  •       Bone marrow damage
  •       Heart attack
  •       Stroke
  •       Death

[Read more...]