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Plavix Bleeding Hemorrhaging Side Effects Lawsuits

Plavix Bleeding Hemorrhaging | Lawsuits, Lawyers | Side Effects: Cerebral Bleeding, Gastrointestinal Bleeding, Hemorrhaging, Thrombotic Thrombocytepenic Purpura (TTP)

Plavix-Aspirin Study halted due to High rate of Bleeding and death A study conducted by the National Institute of Neurological Disorders and Stroke (NINDS) to determine if Plavix-aspirin therapy could prevent recurring strokes...Read More

Learn about Thrombotic Thrombocytopenic Purpura (TTP), a Plavix use side effect

Latest Plavix Bleeding News

If you take Plavix, you should be aware that it can cause serious bleeding and hemorrhaging, especially cerebral and gastrointestinal bleeding, in addition to Thrombotic Thrombocytepenic Purpura (TTP). Several studies have found that Plavix users have an alarmingly high rate of hemorrhaging, cerebral and gastrointestinal bleeding, and Thrombotic Thrombocytepenic Purpura (TTP) compared with people not taking the drug. In many cases, Plavix cerebral and gastrointestinal bleeding and hemorrhaging is serious enough to be life threatening.

If you took Plavix and suffered from cerebral bleeding, gastrointestinal bleeding or hemorrhaging, you may be eligible to receive compensation through a Plavix lawsuit. The attorneys at the personal injury law firm of Parker Waichman LLP are offering free legal consultations to victims of these serious Plavix side effects. We urge you to contact one of our Plavix lawyers today to protect your legal rights.

Plavix Gastrointestinal Bleeding and Hemorrhaging

Plavix (generic: clopidogrel bisulfate) was approved in 1997 for prevention of blood clots and to reduce the risk of heart attacks and strokes.  Plavix is the sixth top selling drug in the U.S., with sales totaling $3.8 billion dollars. It is often prescribed in conjunction with low dose aspirin therapy to prevent heart attacks in high-risk patients.

Plavix's initial warning label made no mention of serious gastrointestinal bleeding. A recent study in the New England Journal of Medicine found that patients taking Plavix are 12 times more likely to suffer recurrent ulcers, 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 published in the Archives of Internal Medicine found the risk of hemorrhaging among Plavix-aspirin patients was significantly higher than thought. For years, it was thought the Plavix-aspirin combination would cause less bleeding than an alternative blood thinner, Warfarin.

While the CDC study did find that Warfarin was associated with a higher rate of bleeding than the Plavix-aspirin combo, the combination therapy did not do as well in that area as was expected. For both regimens, the number of hospital admissions because of bleeding was similar. And bleeding-related visits to emergency department visits were only 50 percent lower for those on the Plavix-aspirin combo.

Plavix and Proton Pump Inhibitors

The problem of Plavix gastrointestinal bleeding was further complicated after the U.S. Food & Drug Administration (FDA) warned that people taking the blood thinner should avoid heart burn drugs like Prilosec. Drugs like Prilosec, as well as Nexium, Prevacid, Aciphex, and Protonix, are often prescribed to reduce the risk of gastric bleeding from the Plavix-aspirin combo.

In November 2009, the FDA said such drugs, known as Proton Pump Inhibitors, could inhibit the effectiveness of Plavix. According to the FDA, 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. It was already known that 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).

Legal Help for Victims of Plavix Bleeding

If you or a loved one suffered cerebral bleeding, gastrointestinal bleeding, internal hemorrhaging or Thrombotic Thrombocytepenic 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 LAW INFO (1-800-529-4636) today.

Plavix Timeline

Nov. 17, 1997: The U.S. Food and Drug Administration (FDA) Plavix to prevent and reduce the occurrence of atherosclerotic events such as myocardial infarction, stroke and blood clots in patients who have a history these diseases. The drug is manufactured by Sanofi-Aventis and Bristol-Myers Squibb Co.

Jan. 20, 2005: The New England Journal of Medicine publishes a study showing that Plavix patients tend to have a higher rate of ulcers than patients taking aspirin combined with a heartburn pill. Lead author Dr. Francis Chan states that some patients should also consider switching to Aspirin because it is much less expensive than Plavix, and available over-the-counter.

Apr. 20, 2006: The New England Journal of Medicine publishes a study demonstrating that Plavix combined with Aspirin has no significant benefit over Aspirin therapy alone in treating patients at risk for atherosclerotic events.

Aug. 8, 2006: Canadian manufacturer Apotex Corp. markets a generic version of Plavix as part of an “at-risk launch”. Bristol-Myers Squibb Co. and Sanofi argue that their patent is valid, and Apotex should not be allowed to sell the drug.

Aug. 17, 2006: The FDA approves Plavix for acute ST-segment elevation myocardial infarction (STEMI) patients who are not undergoing angioplasty. A STEMI is a severe type of heart attack triggered by the completely blocked artery.

Jan. 26, 2009: The FDA announces an ongoing safety review of Plavix used in combination with proton pump inhibitors (PPIs) such as omeprazole (sold under the brand name Prilosec, Prevacid). The agency cites conflicted findings about this interaction; some studies indicate that PPIs may reduce the effectiveness of Plavix, while others do not. The FDA also informs the public that the effectiveness of Plavix may vary between patients based on their genetic metabolic tendencies.

May 2009: The FDA includes information about the reduced effectiveness of Plavix in patients who are unable to properly metabolize the drug.

Nov. 17, 2009: The FDA states that the Plavix safety label will be updated, and cites data showing that anti-clotting activity may be half as effective when Plavix is taken with omeprazole.

2010: Plavix sales reach over $6.1 billion in the U.S. and $9.1 billion worldwide.

Mar. 12, 2010: The FDA issues a “black box warning” for Plavix, to “Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.” Genetic testing is available to determine whether or not a patient can properly metabolize Plavix.

Jan. 2011: The FDA extends Plavix’s patent expiration date by an additional six months. The date is now set for May 17, 2012.

Feb. 8, 2012: Apotex pays over $442 million to end the patent infringement case with Plavix manufacturers.

Feb. 21, 2012: The Cardiovascular and Cerebrovascular Disease journal publishes a study showing that Aspirin can be just as effective as Plavix in improving leg circulation for patients with peripheral artery disease (PAD).

References:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020839_plavix_toc.cfm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108712.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079520.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190787.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm http://health.usnews.com/health-news/news/articles/2012/02/21/aspirin-as-good-as-plavix-for-poor-leg-circulation-study
http://query.nytimes.com/gst/fullpage.html?res=9F01E0D61338F933A15752C0A9639C8B63
http://www.nejm.org/doi/full/10.1056/NEJMoa060989
http://www.dailyfinance.com/2011/02/27/top-selling-drugs-are-about-to-lose-patent-protection-ready/
http://online.wsj.com/article/SB10001424052748704698004576104241735368126.html
http://www.cbsnews.com/8301-500395_162-57373391/drugmaker-pays-$442m-in-plavix-patent-case/
http://www.inpharm.com/news/155632/plavix-sales-plummet-england