Plavix Hit With FDA’s Toughest Warning

Plavix is getting a “black box” warning to its label from the US Food and Drug Administration (FDA) because the popular blood thinner can be less effective in some patients, potentially putting them at greater risk of heart attack and stroke.

Patients with cardiovascular disease are prescribed Plavix (clopidogrel bisulfate) to reduce formation of blood clots, which can lead to stroke, heart attack and death.  The boxed warning – the FDA’s strongest caution — highlights the diminished effectiveness of Plavix in patients who have a genetic variation that inhibits their ability to metabolize the drug.

The FDA says that patients with this genetic variation have reduced functioning of a certain liver enzyme and thus cannot metabolize the drug to convert it to its active form. It is estimated that between 2 percent to 14 percent of Americans are poor metabolizers. These patients represent about 14 percent of Chinese, 4 percent of blacks, and 2 percent of whites, according to Bristol-Myers Squibb and Sanofi-aventis, which jointly market the drug. The FDA says genetic tests can identify if a patient is a poor metabolizer.

Patients should not stop taking Plavix unless told to do so by their doctor. Always consult your physician before making any changes to your medications.

As always, Sokolove Law is here to help protect your rights.