Stroke survivors take note: FDA notice on Plavix

SOURCE: FDA MedWatch

Plavix (clopidogrel):

Reduced effectiveness in patients who are poor metabolizers

Audience: Cardiology healthcare professionals, patients

FDA notified healthcare professionals and patients that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood 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 healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.
  • Advise healthcare 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 blood cells called platelets, making platelets less likely to form blood clots. A data summary and additional information for healthcare professionals and patients are provided in the linked Drug Safety Communication.

Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety Communication at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204256.htm

Did you know? MedWatch is a free service of the FDA and you can opt in to their email list to get updates like this one delivered to you-no charge.  Visit the link to their site above to sign up.


I’ve included this MedWatch update as many of my readers are stroke survivors and may be on Plavix.  If you have specific concerns about this update and how it may apply to you please contact your physician. I am simply making sure you are informed.  You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Source:  U.S. Food & Drug Administration (FDA).

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