FDA announces ongoing safety review of clopidogrel

In an “early communication” posted on its website, the FDA announced today that it was examining the safety of clopidogrel.

The review is a response to recent studies showing widespread variability in the efficacy of clopidogrel,  based on genetic differences in the metabolism of the drug, or when it is administered with other drugs, such as PPIs.

Eric Topol told CardioBrief that “pending work that needs to be done,” he believes that “genotyping for CYP2C19 will be indicated if it is shown that increasing the dose of clopidogrel overrides the lack of anti-platelet action.” He was more skeptical about the PPI story, noting that “the same scare with some statins proved a non-issue,” but agreed that the issue required further study.

The FDA told Dow Jones  that it was working with Bristol-Myers to update the drug’s label and that it was in discussions with Bristol-Myers and its partner on the drug, Sanofi-Aventis, about new clinical trials concerning this issue.