Plavix (clopidogrel) is a prescription anti-platelet medication used to prevent stroke and heart attack in patients with cardiovascular disease. Plavix works by making blood platelets less likely to form clots. It is generally taken in tablet form, once per day by mouth. Plavix is one of the best selling drugs worldwide, with over $8 billion dollars in annual sales. As with many medications, Plavix may cause serious side effects, including:
• difficulty breathing and swallowing
• swelling of the face, throat, feet, ankles and lower legs
• bloody stools or vomit
• unusual bleeding or bruising
• slow or difficult speech
• weakness or numbness in an arm or leg
• vision loss
• fast heartbeat
• purple patches or bleeding under the skin
• yellowing of the skin or eyes
Drugs come with side effects. We all get that. So that is not the question. Instead, the question is whether the maker of Plavix knew that people who are unable to metabolize Plavix adequately were at greater risk for a heart attack. Since Plavix will not work until it is metabolized in the body, these individuals are at a greater risk for heart attack and stroke. This increased risk is so great that in March of 2010, the FDA added what is known as a “Black Box Warning” to Plavix to alert both patients and physicians that the drug can be less effective in those patients who are unable to metabolize it into the active form. It is estimated that as many as 14% of the U.S. population are poor metabolizers of Plavix.
The manufacturers of Plavix — Bristol-Myers Squibb and Sanofi-Aventis Pharmaceuticals – have a long history of consumer deceit and misleading marketing practices surrounding the drug. They have received numerous warning letters from the U.S. Food and Drug Administration (FDA):
- 1998: A September warning letter from the FDA reprimanded the manufacturers for promoting Plavix for use in patients receiving stents, a use for which the drug was not approved. The letter also accused the manufacturers of improperly recommending a dose that was approximately four times higher than the approved dose, and for failure to adequately warn consumers about the potential risks associated with taking Plavix.
- 1998: An additional letter from the FDA in December cited false and misleading statements in product brochures, medical journal advertisements and promotional videos, all of which claimed that Plavix® was superior to aspirin. The letter also accused the manufacturers of failure to present information about the side effects, warnings, and precautions associated with taking Plavix.
- 2001: A May warning letter from the FDA mandated that the manufacturers cease their promotion of unsubstantiated claims about Plavix, including presenting selective information in advertisements while ignoring unfavorable data
- 2001: A subsequent warning letter in September notified the manufacturers that they were in violation of Federal regulations by failing to adequately report the number of serious adverse reactions to Plavix in a timely manner.
Studies continue to demonstrate that Plavix shows no measurable benefit over its much cheaper and safer alternative – aspirin. Most recently in October of 2011, the National Institute of Neurological Disorders and Stroke (NINDS) halted a large multi-national randomized study of stroke prevention following a scheduled data review when the analysis revealed that 6.5% of patients who were randomized to take both Plavix and aspirin experienced a bleeding event, versus 3.3% of the patients randomized to the aspirin-alone arm. The Plavix/aspirin combination arm also experienced more deaths.
Plavix lawsuits allege is the responsibility of the manufacturers (Bristol-Myers Squibb and Sanofi-Aventis Pharmaceuticals) to adequately warn consumers of the potential side effects and to market the drug for only those purposes for which clinical trial data support its effectiveness. Based on their history of misleading advertising, marketing and promotion, the manufacturers of Plavix have failed consumers by neglecting their duty to act in the best interest of patient safety.
Amid growing concern surrounding the serious risks associated with taking Plavix, and in response to the blatant disregard for patient safety by the manufacturers, numerous individual lawsuits for Plavix are currently being reviewed while several class action lawsuits have already been filed in the United States. These lawsuits allege that Plavix is defective in both design and formulation, unsafe for its promoted uses, and that the potentially severe side effects far outweigh any potential benefits.
If you are interested in filing a Plavix lawsuit, you can find more information here.