Monday, March 22, 2010


Over the weekend, I was asked for my opinion on the latest FDA warning issued last week, asking Sanofi-A, the makers of clopidogrel ( Plavix ) to add a box warning " outlining the availability of genetic tests to identify patients who ineffectively convert clopidogrel to its active form". While I can see their reason for so doing, I cannot understand why they did it at this juncture ( I smell a BIG rat ). While it is true that some patients with genetic defiency of the cytochrome CYP 2C19, may not metabolise the drug well ( clopidogrel is a pro-drug ), and therefore may suffer inadequate anti-platelet efficacy, the black label at this point in time only creates confusion. The genetic testing is a research lab test and is not commercially available at the moment, there are no clinical trials carried out to see what to do with this sub-set of patients and what are the choices for the care-giver and patient. You have highlighted a problem, true. BUT what is the solution. Now we have many patients, having read the FDA announcement and read the STAR and NST, become very confused. What shall they do. At the moment, I just ask them to ignore and not to discontinue the clopidogrel.
If I am very naugthy ( and I have no data ), is the FDA in cahoots with Eli Lily to try and promote prasugrel ( Eli Lily )?
See there are also cheats in FDA / USA.

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