Safety Alerts & Recalls
What does this mean?
While the FDA continues its review of the safety of AVANDIA, it will remain available to the public and continue to have the Black Box Warning regarding the risks of heart attacks and new or worsening heart failure. If you are currently taking AVANDIA (or ROSIGLITAZONE), the FDA recommends:
1) Do not stop taking your medication without talking with your healthcare professional.
2) Discuss any questions or concerns you have about AVANDIA with your healthcare professional.
3) Read the Medication Guide that comes with each AVANDIA prescription to better understand the risks and benefits of your medication.
4) Report any side effects with AVANDIA to the FDA MedWatch program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Ongoing Review of AVANDIA (ROSIGLITAZONE) and Cardiovascular Safety
The FDA has now published more information about its ongoing review of AVANDIA (ROSIGLITAZONE). The FDA is reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. The RECORD study (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) is a recently completed large, long-term clinical study designed to evaluate the cardiovascular safety of AVANDIA. The FDA review of AVANDIA is ongoing and no new conclusions or recommendations about the use of AVANDIA in the treatment of type 2 diabetes have been made at this time.
As mentioned in the iGuard alert issued earlier this week, the FDA will present all of the new and existing cardiovascular safety data on AVANDIA at a public advisory committee meeting in July 2010. At that meeting, the advisory committee will provide an updated assessment of the risks and benefits of AVANDIA in the treatment of type 2 diabetes.
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