Is Avandia Safe?
In 2004, the FDA approved Avandia, in combination with insulin, to treat type 2 diabetes. Avandia is the brand name for rosiglitazone. In 2007, the agency reported a possible association between rosiglitazone and an increased risk of cardiovascular events, such as heart attack. It launched an investigation, but did not change its approval status for Avandia.
The FDA examined appropriate studies and conducted a meta-analysis (a review of completed studies) of 22 Avandia clinical trials. These studies encompassed almost 17,000 total patients, of which, roughly 10,000 took Avandia and the rest generally received a placebo. The FDA concluded there was a statistically significant increase in myocardial infarctions (heart attacks) in patients taking Avandia, and the agency established new restrictions, limiting its use to:
- Patients who are already being treated successfully with Avandia, and
- Patients who cannot control their blood sugar with other anti-diabetic medications and who, after consultation with their physician, don't wish to use pioglitazone-containing diabetes medications.
As of November 18, 2011, patients who meet the criteria must enroll in the Avandia-Rosignlitazone Medicine Access Program to receive this medication.
Diabetes mellitus is a group of diseases that affects how the body uses blood glucose (blood sugar), a major source of energy for cells. Diabetics have too much glucose in their blood, which can lead to serious health problems. Avandia (alone or in combination with other diabetes medications) controls blood sugar. It lowers the amount of sugar in the blood by making tissues more sensitive to insulin, a hormone that regulates absorption of sugar into cells.
Unfortunately, the incidence of diabetes is rapidly increasing. Experts estimate about 285 million adults worldwide currently have diabetes mellitus or impaired glucose tolerance, and they expect this number to increase to 438 million by 2030. Oral anti-diabetic drugs help somewhat, but often lose effectiveness over time, leading to the progression of type 2 diabetes and its complications.
Avandia causes your body to retain fluid, which leads to edema (swelling) and weight gain. These can make some heart problems worse or lead to heart failure, especially in combination with insulin.
Talk to your physician about your diabetes treatment. If together you determine the benefits of Avandia outweigh the risks, you can both enroll in the Medicine Access Program.
Food and Drug Administration. "FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety." Web. 22 February 2010.
Food and Drug Administration. "FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl." Web. 18 May 2011. http://www.fda.gov/Drugs/DrugSafety/ucm277629.htm
Food and Drug Administration. "MEDICATION GUIDE 1000 AVANDIA." Web.
Shah, Niren, K.,Pharm.D., Deeb, Wasim E., M.D., Choksi, Rushab, Pharm.D., and Epstein, Benjamin J., Pharm.D. "Dapagliflozin: A Novel Sodium-glucose Cotransporter Type 2 Inhibitor for the Treatment of Type 2 Diabetes Mellitus." Pharmacotherapy (1) (2012): 80-94. Web. 12 February 2012.
Collazo-Clavell,, Maria, M.D. "Diabetes." Mayo Clinic blog. Web. 21 May 2011.
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