Tag Archives: plavix side effects lawsuits

Plavix Lawsuits

Plavix is an antiplatelet medication prescribed to prevent heart attacks and strokes. Manufactured by Bristol-Myers Squibb and Sanofi/Aventis, Plavix is a thienopyridine drug that inhibits platelet activation by blocking the ADP receptor on platelets and costs $4 per pill. This medication has been promoted to medical professionals as a superior drug over simple aspirin in preventing blood clots that can cause heart attacks and stroke for anyone at risk. Manufacturer representatives have convincingly claimed that there is no other medication as effective as Plavix for use after stent placement. The side effects listed on the patient medication guide include increased risk of heart attack, stroke, gastrointestinal bleeding, severe ulcers, and a serious blood disorder called Thrombotic Thrombocytopenic Pupora (TTP).

Several individual lawsuits and class action lawsuits have been initiated since 2010. The lawsuits allege that the makers of Plavix falsely promoted this medication by claiming it has far more benefits than simple aspirin. The suits claim the manufacturers were more interested in increasing sales revenue than providing safety information to both patients and doctors. In the class action suit was filed on behalf of 11 patients in several states who suffered excessive bleeding, heart attacks, strokes, and needed stent replacement while taking Plavix. The lawsuit also claims some patients experienced disfigurement, loss of earning a living, increased medical expenses and permanent heart damage.

Although thousands of patients have been taking Plavix since it was introduced in 1997, there are an increasing number of studies indicating Plavix may have no significant benefit over aspirin, with one study of over 22,000 patients showing only a slight benefit of Plavix versus aspirin. For individuals with high cholesterol and/or high blood pressure, this drug may increase the risk of heart attack, stroke, a serious bleeding event or TTP. Studies have also shown that some people may have a genetic factor that reduces the ability of Plavix to prevent blood clots. There is a test for the CYP2C19 gene variant which should be given to patients before starting Plavix. This information is indicated in a black box warning required by the FDA in 2009.

The FDA issued a reprimand in 1998 to Bristol-Myers Squibb and Sanofi for promoting the use of Plavix for patients who received stents when it wasn’t approved for that application. Another warning letter was issued in 2001 when the manufacturers’ advertising presented favorable information to physicians while ignoring unfavorable data and serious side effects. Federal investigators are continuing to monitor this medication and the claims made by the manufacturer.

Aspirin is a salicylate acid derived from processed plants such as the willow tree. Discovered in Europe in the 19th century, it treats not only fever, forms of arthritis, headache and pain, but it is also an antiplatelet that has been used for years for heart and stroke patients. It inhibits production of a chemical called thromboxane that binds platelets together to create clots and only costs 4 cents per pill. The main side effects of aspirin are gastrointestinal ulcers and stomach bleeding, which may be controlled by using coated aspirin and over the counter heartburn medications.

I’m writing this article because I had to do some research before having a lung biopsy to avoid hemorrhaging due to the blood-thinning effects of Plavix. I was prescribed Plavix and aspirin when I had a stent placed after my heart attack in February. I was not tested for the gene variant and wasn’t even informed that there was a test. My cardiologist insisted that Plavix was the only medication available for me even though the cost is almost $190 as a Medicare recipient. My pulmonologist obtained permission from my cardiologist to take me off both medicines. Today, the pulmonologist informed me that in his research and his conversation with the cardiologist he found that Plavix has only a 15% benefit over aspirin in preventing blood clots. It was his opinion that aspirin works almost as well and the benefits and side effects of Plavix aren’t worth the price. I happen to agree.

Sources:

http://www.heartheavy.com/plavix-law-suit-claims-strokes-heart-attacks-internal-bleeding/

http://ncbi.nlm.nih.gov/pubmedhealth/PMH0000802/