Nationwide Pharmaceutical Litigation Firm
If you or a loved one suffered internal bleeding, ulcers or gastrointestinal bleeding, thrombotic thrombocytopenic purpura (TTP), bleeding or hemorrhagic stroke while taking the anti-clotting drug Plavix® (clopidogrel), you may have cause for a lawsuit. The attorneys of Napoli Bern Ripka Shkolnik, LLP are reviewing potential Plavix lawsuits throughout the United States for people who have suffered serious side effects from this medication.
The U.S. Food and Drug Administration (FDA) approved Plavix in 1997. Doctors prescribe this drug for the prevention of blood clots in patients who have had a bleeding or hemorrhagic stroke or heart attack, including acute coronary syndrome or myocardial infarction, or those diagnosed with peripheral arterial disease (PAD).(1) Marketed by a partnership of Sanofi-Aventis and Bristol-Myers Squibb, Plavix is an antiplatelet drug that works by preventing platelets in the blood from sticking together and forming clots. In 2010, $4.6 billion in retail sales made Plavix #3 on a list of Top 200 Pharmaceutical Sales in the U.S.(2)
Side Effects Associated with Plavix
You may have a case if you or a loved one suffered these side effects:
- Internal bleeding
- Gastrointestinal bleeding
- Cerebral bleeding or hemorrhage
- Heart attack
- Bleeding stroke
- Hemorrhagic stroke
- Death resulting from internal bleeding
- Thrombotic thrombocytopenic purpura, a disorder in which blood clots form in the small blood vessels around the body, including the kidneys, heart and brain, that can restrict or block blood flow and may result in brain damage, stroke or death.(3)
People may not have known or understood the risks for serious side effects when they took this medication. Plavix reduces the bloods ability to form a clot and is associated with major internal bleeding and gastrointestinal bleeding. Bleeding during surgery or from an injury could also be fatal while taking Plavix.
While the American College of Cardiology and American Heart Association have considered Plavix an alternative anti-clotting drug for patients who suffer gastrointestinal intolerance to aspirin, some doctors no longer support this recommendation based upon study results showing aspirin plus esomeprazole was superior to clopidogrel in the prevention of recurrent bleeding of ulcers.(4) Plavix is also associated with the development of ulcers. A Plavix trial found that people taking the drug might suffer more than 12 times as many ulcers as patients who take aspirin plus esomeprazole.(5)
Plavix Drug Interactions with Proton Pump Inhibitors (PPIs)
Because side effects can include ulcers and gastrointestinal bleeding, doctors often prescribe proton pump inhibitors (PPIs) to reduce stomach acid in patients taking Plavix.(6)
In November 2009, the FDA released an advisory saying that taking the Proton Pump Inhibitor omeprazole (marketed as Prilosec/Prilosec OTC) in conjunction with Plavix significantly reduced the effectiveness of Plavix and patients at risk for heart attack or stroke may not be getting the anti-clotting benefits they need. The makers of Plavix agreed to update the drug labeling to include a warning about drug interaction with omeprazole and to conduct further studies into other drug interactions.(7)
The FDA recommended doctors also avoid prescribing esomeprazole (Nexium), cimetidine (Tagamet/Tagamet HB), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid) in combination with Plavix because they are expected to have a similar effect.(8)
Talk to a Knowledgeable Attorney at NBRS
Napoli Bern Ripka Shkolnik, LLP is offering a free consultation for people across the United States who have suffered serious side effects from Plavix and may have reason to file suit. If you or a loved one took this prescription medication and suffered from TTP, ulcers or internal bleeding such as gastrointestinal bleeding, or took Plavix in combination with omeprazole or other drug and suffered a bleeding or hemorrhagic stroke, you may be able to take legal action. Find out how our attorneys can help you seek justice and fair financial compensation for medical care, loss of earnings and more.
(1) Sanofi-Aventis and Bristol-Myers Squibb. (2011, 5). PLAVIX (clopidogrel bisulfate) tablets. Retrieved November 8, 2011, from U.S. Food and Drug Administration:
(2) Drugs.com. (2010). Pharmaceutical Sales 2010. Retrieved November 8, 2011, from
(3) U.S. Department of Health & Human Services, National Heart Lung and Blood Institute. (2011, November 4). What Is Thrombotic Thrombocytopenic Purpura? Retrieved November 8, 2011, from National Heart Lung and Blood Institute:
(4) Chan, F. K., Ching, J. Y., Hung, L. C., Wong, V. W., Leung, V. K., Kung, N. N., et al. (2005). Clopidogrel versus Aspirin and Esomeprazole to Prevent Recurrent Ulcer Bleeding. The New England Journal of Medicine , 352:238-244 -
(5) Drugs.com. (n.d.). Plavix Side Effects. Retrieved November 8, 2011, from
(6) U.S. Department of Health & Human Services, U.S. Food and Drug Administration. (2009, January 26). Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix). Retrieved November 8, 2011, from U.S. Food and Drug Administration:
(7) U.S. Department of Health & Human Services, U.S. Food and Drug Administration. (2009, November 17). Public Health Advisory: Updated Safety Information about a drug interaction between Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC). Retrieved November 8, 2011, from U.S. Food and Drug Administration.
(8) U.S. Department of Health & Human Services, U.S. Food and Drug Administration. (2009, November 17). Information for Healthcare Professionals: Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC). Retrieved November 8, 2011, from U.S. Food and Drug Administration: