FDA: Boxed Warning on Plavix

  • Date: March 15, 2010
  • Source: admin
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FDA has announced new boxed warning on Plavix. Plavix, which is an anti-blood clotting drug, can prove to be less effective in people who cannot digest the drug to convert it to its active form.

Plavix is one of the most effective medicines in terms of alleviating the risk of heart attack, unstable angina, cardiovascular death, and stroke in patients by making platelets less likely to form blood clots. Nevertheless, for its proper functioning, Plavix needs to be metabolized into its active form by the liver enzyme, CYP2C19.

Plavix and Poor Metabolizer

With reduced functioning of CYP2C19 liver enzyme, people cannot effectively convert Plavix to its active form. As a result, Plavix becomes less effective in altering platelet activity in those people. Therefore, people who are poor metabolizer fail to receive the full benefit of Plavix treatment and remain at risk for heart attack, stroke, and cardiovascular death.

As found that 2% to 14% of the U.S. population are poor metabolizers, Mary Ross Southworth, Pharm.D., clinical analyst in the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research says that “We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients”.

It is highly recommended by the FDA that patients should consult their health care professionals before taking or stopping dosage of Plavix.


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