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. Author manuscript; available in PMC: 2011 Dec 1.
Published in final edited form as: Stroke. 2010 Oct 28;41(12):2997–3002. doi: 10.1161/STROKEAHA.110.594069

Table 3.

FDA Black box warning on clopidogrel (Plavix)

  • ∎

    Effectiveness of Plavix depends on activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19.

  • ∎

    Poor metabolizers treated with Plavix at recommended doses exhibit higher cardiovascular event rates following acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) than patients with normal CYP2C19 function.

  • ∎

    Tests are available to identify a patient's CYP2C19 genotype and can be used as an aid in determining therapeutic strategy.

  • ∎

    Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers.

FDA = Food and Drug Administration.

Table reprinted from the U.S. Food and Drug Administration.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf (Accessed 8/1/2010).