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Date: Fri, 4 Feb 2011 11:05:35 -0600
From: fda@service.govdelivery.com
Subject: FDA MedWatch - UPDATE: Avandia (rosiglitazone): Information on cardiovascular risks (including heart attack) added to labeling and Medication Guide
To: guyperea@live.com

Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

In patients already being treated with these medicines
In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, labeling, and medication guide, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm

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