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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

clopidogrel

  • 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


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.

 

Saleem
Saleem
Saleem founded Xcode with a vision to bring India into the forefront of personal genomics. He received the prestigious MIT TR35 award in 2013 and, under his leadership, Xcode has won several awards including Most promising startup of the year (2014) by Biospectrum and Hottest startup of the year (2013) by Business World.