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Clopidogrel: What Is a Cardiologist to Do?

The FDA required a black box warning for clopidogrel based on the assumption that it was a CYP2C19 substrate. Therefore, those patients with defective CYP2C19 alleles would not be as able to effectively metabolize clopidogrel to the active metabolite. The boxed warning informed the physician that “tests are available to identify a patient’s CYP2C19 genotype and can be used as an aid in determining therapeutic strategy.” Thus, in some hospitals, as well as the cost, PCIs could be delayed, until such genotyping was completed, as the hospital might be subject to liability, if there was a bad outcome in a patient, whose CYP2C19 genotype was unknown. Unfortunately, because FDA did not require the patients to be genotyped, most insurers did not reimburse additional costs incurred by genotyping. Those patients needing a percutaneous coronary intervention (PCI) are at high risk and FDA acted appropriately in placing this warning. There were, though, already some concerns, as to whether clopidogrel was indeed a CYP2C19 substrate, as it had previously considered to be a CYP3A substrate. Now there is serious doubt. FDA should review their position on the clopidogrel black box and ensure that the label is still “truthful and not misleading.” While most physicians welcome prompt action by FDAwhen a risk with a drug is identified, others have noted FDA’s inconsistencies in their updating of drug labels. Seminerio and Ratain have suggested that FDA adopt a more stringent protocol for such updating. Based on the amount of usage, clopidogrel should surely qualify for such an updating.