DIABETES
October 3, 2010

FDA Restricts Diabetes Drug

The FDA has issued restrictions on who can be prescribed the type 2 diabetes drug Avandia. There is a confirmed heart risk.

The FDA announced last week that prescribing the type 2 diabetes drug Avandia® (rosiglitazone) to new patients will be restricted because of significant risks to the heart, including heart failure and stroke. The drug is intended for diabetics who have not responded to other treatments, and is designed to be part of a regimen that includes weight loss and exercise.

Clinicians will have to explicitly document why their patient must be prescribed Avandia, and patients will have to read and sign documents that explain the heart risks associated with taking the drug.

Avandia is part of a class of drugs called the thiazolidinediones, of which there is only one other, Actos®. The FDA has ruled that the drug’s maker, GlaxoSmithKline must develop a strategy for assessing and reducing the risk of the drug, called a risk evaluation and mitigation strategy or REMS. Under the REMS, patients can only be prescribed Avandia if other methods are ineffective, and if they are unable to take Actos. Furthermore, clinicians will have to explicitly document why their patient must be prescribed Avandia, and patients will have to read and sign documents that explain the heart risks associated with taking the drug.

The FDA also halted GlaxoSmithKline’s clinical trials comparing classic diabetes drugs to Avandia and Actos.

FDA Commissioner Margaret A. Hamburg says, "[t]he FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care."

Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, adds that "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."

Time will tell how the new regulations will affect prescription of the drug and how this will affect type 2 diabetes patients. If you are on Avandia, it is important to talk to your doctor about any concerns you may have about using the medication.

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