US FDA revises its black box warning on Plavix (Clopidogrel)

The Food and Drug Administration (FDA) has made several changes to the prescribing information for Plavix (clopidogrel bisulfate tablets; Bristol-Myers Squibb and Sanofi).

The updated box warning include the following:
WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE

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  • Effectiveness of Plavix depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19
  • Tests are available to identify patients who are CYP2C19 poor metabolizers
  • Consider use of another platelet P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers

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Xcode offers genetic test that helps in determining whether a patient is a carrier of loss of functions.

    • The test is required only once in lifetime
    • The test is done using saliva (non-invasive) sample
    • The patient will benefit from significant cost savings

If you are a physician and interested in offering the test to your patients, please contact us.