Plavix is a blood thinning medication used to reduce the risk of blood clots that can lead to heart attack and stroke. It is prescribed to patients who are at high risk for cardiovascular events. When the drug was launched by Sanofi-Aventis and Bristol-Myers Squibb in 1997, it was touted as a superior version of Aspirin. However, over the years research has shown that even though Plavix costs 100 times as much as Aspirin, it is not more effective. In fact, some studies have also found that Plavix also has a higher risk of complications and death compred to Aspirin.
Numerous lawsuits have been filed across the country over Plavix-related injuries. Plaintiffs have alleged that the blood thinner caused internal bleeding events such as gastrointestinal bleeding or cerebral bleeding. The lawsuits also allege that Sanofi and BMS misrepresented the safety profile of Plavix by claiming that it was better than Aspirin in order to raise profits. At one point, Plavix was once the world’s second-best selling drug.
Research has also found that some patients are unable to metabolize Plavix due to low levels of a certain enzyme needed to break down the drug. Patients with this genetic predisposition taking Plavix are therefore unknowingly placed at an increased risk for heart attack and stroke despite paying for this costly medication.
See below for a comprehensive timeline that includes the history of Plavix, dates of label changes and updates on lawsuits and potential settlements.
Timeline: Plavix (clopidogrel)
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).
Mar. 20, 2012: A study published in the Annals of Internal Medicine finds that the benefits of Plavix “are uncertain and are potentially outweighed by bleeding hazards” in patients with chronic kidney disease (CKD).
May 17, 2012: The patent on Plavix expires. The FDA approves generic versions of the drug.
Aug. 30, 2012: The New England Journal of Medicine publishes a study showing that a Plavix-Aspirin combination significantly increased the risk of bleeding and death compared to Aspirin alone in patients who have had a lacunar stroke. Furthermore, researchers found that the combination did not reduce the risk of recurrent stroke.
Sept. 26, 2012: The Journal of the American College of Cardiology publishes a study showing that Plavix is associated with a greater number of deaths compared to Brilinta (Ticagrelor) among 1,200 patients who had undergone coronary artery bypass graft (CABG) surgery. In analyzing the factors that caused or contributed to patient death, Plavix was associated with higher rates of bleeding and infection.
Mar. 2013: In a filing with the US Securities and Exchange Commission, Sanofi reveals that it is being investigated by the Department of Justice over claims it made about Plavix to the FDA. The company stated that, “In June 2012, Sanofi U.S. became aware that the U.S. Department of Justice is investigating disclosures to the FDA regarding the variability of response to Plavix®. Sanofi U.S. is cooperating with the U.S. Department of Justice in this matter.” http://www.sec.gov/Archives/edgar/data/1121404/000104746913002333/a2212980z20-f.htm