Audience: cardiology health care professionals, patients
March 12, 2010 — The FDA notified health care professionals and patients that a boxed warning has been added to the prescribing information for Plavix, an anti-clotting medication. The boxed warning in the drug label will include information to:
- Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.
- Inform health care professionals that tests are available to identify genetic differences in CYP2C19 function.
- Advise health care professionals to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.
Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease. Plavix works by decreasing the activity of platelets, making them less likely to form blood clots. A data summary and additional information for health care professionals and patients are provided in the Drug Safety Communication.
March 12, 2010 — Drug Safety Communication: reduced effectiveness of Plavix (clopidogrel)
March 12, 2010 — Information on clopidogrel bisulfate (marketed as Plavix)
