FDA Lifts Restrictions on Diabetes Drug Avandia

The U.S. Food and Drug Administration has removed restrictions on the prescribing and use of an oral drug called Avandia (Rosiglitazone) that is used to treat patients with type 2 diabetes.

The drug has always been a subject of criticism as several thousand patients in the U.S. facing cardiovascular side effects and other lifer threatening complications had filed lawsuits against Avandia's manufacturer GlaxoSmithKline. In 2007 that FDA publicized heart risks associated to the drug Avandia

FDA took the decision to lift some restrictions on the drug based on the recommendations of the expert advisory committees.

GSK's top selling medicine-Avandia with sales of $ 3.2 billion in 2006 was pulled from the market shelves in Europe in 2006 and in U.S. the drug had severe warnings on its use in 2010 due to the risk factors seen in the Record Study, source Reuters.

According to the results of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial, patients being treated with Avandia, do not suffer an increased risk of heart attack or death when compared to the standard-of -care diabetes drugs. Whereas this data do not match the results of the meta analysis of clinical trials that were reported in 2007 indicating the increased risk of heart attacks.

"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."

With this latest action of the FDA, the drug Avandia will carry modified labelling indicating the risk about cardiovascular safety. But, patients will not have to go through the Risk Evaluation and Mitigation Strategy (REMS) program. Also the diabetes patients will be able to receive the oral drug again through the retail pharmacies or mail order service. Above all it will not be limited to just a certain number of patients.

FDA hopes that with the new indication will mention the drug should be taken along with diet and exercise to maintain blood sugar in those with type 2 diabetes mellitus.

FDA also said it is 'releasing' the manufacturer from the postmarket requirement to conduct TIDE: Thiazolidinedione Intervention with Vitamin D Evaluation, comparing Avandia to Actos the only drug that is approved in the thiazolidinedione class.

The oral durg Avandia is available in mixture with other diabetes medications such as metformin, and it is sold under the brand name Avandamet. Similarly it is combined with glimepiride and sold under the brand name Avandaryl.