Last Friday, the Food and Drug Administration said that it will add a Black Box warning to the popular blood thinner, Plavix. The drug is marketed to physicians and patients on television as a drug that will prevent against a future heart attack or stroke. Notably, the Plavix website makes no mention of the recent black box warning.
The new warning cautions doctors that some patients with a genetic variation cannot metabolize Plavix properly, diminishing its effectiveness. Patients can determine whether they are at risk for poor metabolism by simply taking a blood test to determine whether they have low levels of the liver enzyme necessary to break down the drug. The FDA recommends that these patients use other blood thinners, like aspirin. However, due to the $500 cost, some experts believe it is unlikely that such testing will become standard for all patients taking Plavix.
Patients that may not respond to Plavix vary by race, with the highest percentage of non-responders being Chinese, according to the prescribing information given by the drug manufacturers, Sanofi-Aventis and Bristol-Myers Squibb. In total, non-responders account for three percent of the population, but numbers as high as 14% have been reported, according to the The LA Times.
A spokesperson for New York-based Bristol-Meyers said that the company would add the new labeling to bottles of Plavix over the next two months.
Another warning about Plavix was issued by the FDA in November, 2009, which stated that taking heartburn medications such as Prilosec and Nexium simultaneously with the drug could prevent it from working. Regulators said that the key ingredient in the heartburn medications blocks the same liver enzyme needed to break down Plavix, decreasing it’s efficacy.
If you or a loved one have purchased Plavix and now need to switch to another blood thinner, like Aspirin, please contact Pogust, Braslow & Millrood to see if you have a potential claim.