Safety Alerts & Recalls

What does this mean?

Healthcare professionals have known about the issue of poor metabolizers of Plavix for some time - in May 2009 the FDA added this information to the drug label. However, based on additional data reviewed by the FDA, the Boxed Warning is now being added to highlight the reduced effectiveness of Plavix in poor metabolizers.

This alert is to inform you that some patients do not convert Plavix to its active form as well as other patients. These patients may not get the same benefit from Plavix and are known as poor metabolizers. It is estimated that 2 to 14% of the population are poor metabolizers - the rate varies based on racial background. If you take Plavix, you should talk with your healthcare professional to see if you need testing to determine your metabolizer status.

The FDA also recommends:

1) If you take Plavix, you should continue taking it. Do not stop taking Plavix unless told to do so by your healthcare professional.

2) If you have any other concerns about Plavix, you should talk to your healthcare professional.

FDA Adds Boxed Warning to Plavix (Clopidogrel)

The U.S. Food and Drug Administration (FDA) today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who are "poor metabolizers" and cannot metabolize the drug to convert it to its active form in the body. The warning also states that tests are available to identify patients who have the genetic differences in their liver enzymes which make them poor metabolizers of Plavix. Healthcare professionals may need to use other anti-blood clotting medications or different dosing strategies for Plavix in patients identified as poor metabolizers.

Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and heart disease related death in patients with heart disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots. Before it can work in the body, liver enzymes must metabolize Plavix to its active form.

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Source: FDA
Publication Date: 2010-03-12
Last Updated: 2010-03-13

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