March 12th, 2010
Friday March 12: Plavix Gets a Black Box
Larry Husten, PHD
The FDA has added a black box warning to the Plavix (clopidogrel) label. The black box warns about people “who do not effectively metabolize the drug… and therefore may not receive the full benefits of the drug.” The warning also informs healthcare professionals about tests that can identify the underlying genetic differences in clopidogrel metabolism and advises them “to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.” Click here for the full FDA communication.
2 Responses to “Friday March 12: Plavix Gets a Black Box”
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a warning based on platelet activation studies??
Really interesting move here. Is the FDA suggesting that everyone on clopidogrel undergo testing to see if they are a responder? Are they sure that such a strategy will result in a better net result than our current pattern of care? Strictly speaking their statement is correct — but how will people interpret it — and act on it? Is it useful to say these patients may not receive the full benefits of the drug???
a label with a warning but no directions
I had heard that this was coming out and getting various pharmaceutical companies worried about what it means — not just for clopidogrel but for all drug areas where pharmacogenetics data may be emerging. But after they saw the label, most concluded it wouldn’t change practice much because nobody would know how to interpret it. I think they’re right…