FDA to Greatly Restrict Use of Rosiglitazone

Action is response to data suggesting higher risk of cardio events with use of the diabetes drug
By Andrea Mongler
HealthDay Reporter

THURSDAY, Sept. 23 (HealthDay News) -- The U.S. Food and Drug Administration has announced plans to substantially restrict the use of rosiglitazone (Avandia) in type 2 diabetes patients unable to control their disease with other medications.

The agency is taking the action in response to data suggesting an increased risk of cardiovascular events, including stroke and myocardial infarction, in patients treated with rosiglitazone. The FDA is requiring the drug's manufacturer, GlaxoSmithKline, develop a restricted access program for the drug, which will be available to new patients only if they cannot achieve glucose control with other medications and cannot take pioglitazone. Current rosiglitazone users can keep taking the drug if they are benefiting.

Under the new program, physicians will need to attest to and document patient eligibility, while patients will have to review and acknowledge cardiovascular safety concerns associated with rosiglitazone. The FDA has also ordered GlaxoSmithKline to convene an independent group of scientists to review the RECORD trial, which compared the safety of rosiglitazone and standard diabetes drugs. During this trial, questions arose about potential bias in the identification of cardiovascular events. In addition, the FDA has stopped GlaxoSmithKline's TIDE trial, which compared rosiglitazone to pioglitazone and standard diabetes drugs.

"Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

More Information

Copyright © 2010 HealthDay. All rights reserved.

Powered by

jQuery UI Accordion - Default functionality

For life-long learning and continuing professional development, come to Lippincott's NursingCenter.

Nursing Jobs Plus
Featured Jobs
Recommended CE Articles

Debunking Three Rape Myths
Journal of Forensic Nursing, October/December 2014
Expires: 12/31/2016 CE:2.5 $24.95


Drug updates and approvals: 2014 in review
The Nurse Practitioner, 13December 2014
Expires: 12/31/2016 CE:3 $27.95


Can Food Processing Enhance Cancer Protection?
Nutrition Today, September/October 2014
Expires: 10/31/2016 CE:2 $21.95


More CE Articles

Subscribe to Recommended CE

Recommended Nursing Articles Evidence Based Practice Skin Care Network NursingCenter Quick Links What’s Trending Events