FDA Drug Safety Communication

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FDA Date: 3/12/10

Plavix (clopidogrel bisulfate) FDA Drug Safety Communication

Reduced Effectiveness of Plavix (clopidogrel) in Patients Who Are Poor Metabolizers of the Drug

FDA has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. The Boxed Warning is about patients who do not effectively metabolize the drug (ie, "poor metabolizers") and therefore may not receive the full benefits of the drug.

The Boxed Warning in the drug label will include information to:

- Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.

- Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.

- Advise healthcare professionals to consider use of other antiplatelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.

View the full FDA Drug Safety Communication on FDA.gov