Plavix is a blood thinning drug used to prevent a blood clot, stroke or heart attack. This medication, however, may also cause severe bleeding in some patients who take the drug. Numerous lawsuits across the country allege that Plavix caused complications such as cerebral hemorrhaging (brain bleeding) and gastrointestinal hemorrhaging (abdominal bleeding). These claims are supported by several research studies showing that people who take Plavix have a higher rate of bleeding events compared to those not taking the drug. These studies also found that Plavix users had a higher risk of a condition known as Thrombotic Thrombocytopenic Purpura (TTP). In many cases, Plavix cerebral and gastrointestinal bleeding is life threatening.
Plavix and Gastrointestinal Hemorrhaging
Plavix (generic: clopidogrel bisulfate) was approved in 1997 for prevention of blood clots and to reduce the risk of heart attacks and strokes. It is manufactured by Bristol-Myers Squibb and Sanofi. Plavix is the sixth top-selling drug in the U.S., with sales totaling $3.8 billion. It is often prescribed in combination with low-dose aspirin therapy to prevent heart attacks in high-risk patients.
As many lawsuits point out, Plavix’s initial warning label made no mention of serious gastrointestinal bleeding. One study in the New England Journal of Medicine found that patients taking Plavix are 12 times likelier to suffer recurrent ulcers and gastrointestinal or cerebral bleeding from taking Plavix than those who received a combination of aspirin and a heartburn pill. Another study, conducted by the U.S. Centers for Disease Control and Prevention (CDC) and published in the Archives of Internal Medicine, found that the risk of hemorrhaging among Plavix-aspirin patients was significantly higher than expected. These two studies are only brief examples of research showing that Plavix is linked to a higher risk of bleeding.
Plavix and Proton Pump Inhibitors
In 2009, the U.S. Food & Drug Administration (FDA) warned that people taking Plavix should avoid a class of heartburn drug known as Proton Pump Inhibitors (PPIs), which includes drugs like Prilosec, Nexium, Prevacid, Aciphex, and Protonix. They are sometimes prescribed to reduce the risk of gastric bleeding from the Plavix-aspirin combo. The FDA warned that such drugs could inhibit the effectiveness of Plavix. Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme CYP2C19. People who have reduced functioning of their CYP2C19 liver enzyme are unable to effectively convert Plavix to its active form.
Prilosec blocks the CYP2C19 liver enzyme, thereby reducing the effectiveness of Plavix. According to the FDA, it is unknown how other PPIs may interfere with Plavix. Other drugs that should not be used with Plavix because they may have a similar interaction with CYP2C19 include Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).
Users and State Authorities Sue over Plavix
Parker Waichman represents numerous clients in Plavix lawsuits around the country. People who are suing over the drug allege that it caused injuries such as cerebral and gastrointestinal bleeding. The lawsuits also allege that BMS and Sanofi knew about these risks, but didn’t warn consumers. Another issue is that the Plavix makers have said that Plavix is better than aspirin, a claim that is allegedly untrue and harmful since aspirin has a lower risk of complications.
Individual Plavix users are not the only ones suing over the blood thinner. In fact, the attorneys general of West Virginia and Mississippi have also alleged that the manufacturers falsely marketed Plavix. According to these lawsuits, the companies made false claims about Plavix being superior to aspirin. The lawsuits also allege that Sanofi and BMS should have known that some patients can’t properly metabolize Plavix.
Legal Help for Victims of Plavix Bleeding
If you or a loved one suffered cerebral bleeding, gastrointestinal bleeding, internal hemorrhaging or Thrombotic Thrombocytopenic Purpura (TTP) while taking Plavix, you may have valuable legal rights. To discuss your case with one of our Plavix lawyers, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529).