foodconsumer.org: FDA Advisory on Diabetes Drug Avandia

FDA Advisory on Diabetes Drug Avandia
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admin on 02/23/2010 23:01:00
 
The Food and Drug Administration (FDA) is reviewing data submitted in August
2009 from a large, long-term study on possible heart-related risks with the
diabetes drug Avandia (rosiglitazone).
FDA’s review is ongoing. No new conclusions or recommendations about the use
of rosiglitazone in the treatment of type 2 diabetes have been made at this
time.
After FDA completes its review, the agency will hold a public meeting in July
2010 to
present all the known heart-related safety data on rosiglitazone
provide an updated assessment of the risks and benefits of rosiglitazone in the
treatment of type 2 diabetes
Advice for People Who Take Rosiglitazone
Don’t stop taking your medication without talking with your health care
professional.
Discuss any questions or concerns you have about rosiglitazone with your health
care professional.
Read the Medication Guide that comes with each rosiglitazone prescription to
better understand the risks and benefits of your medication.
Report any side effects with rosiglitazone to FDA's MedWatch program either
online, by regular mail, by fax, or by phone.
Online
Regular Mail: Use postage-paid, pre-addressed FDA form 3500
Fax: 1-800-FDA-0178
Phone: 1-800-332-1088
Brand Name Drugs Containing Rosiglitazone
Rosiglitazone is a medication used to treat type 2 diabetes mellitus. It is sold
as a single-ingredient product under the brand name Avandia. It is also
available in combination with other diabetes medications:
metformin under the brand name Avandamet
glimepiride under the brand name Avandaryl
Previous FDA Actions
FDA has been reviewing other studies of rosiglitazone on an ongoing basis as
these studies are published.
In 2007, FDA issued a safety alert about a possible association between
rosiglitazone and  increased heart-related risk.
On July 30, 2007, FDA sought advice from experts outside of the agency at a
joint meeting of two of FDA’s advisory committees.
This article appears on FDA's Consumer Updates page, which features the latest
on all FDA-regulated products.
Date Posted: February 23, 2010