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FDA Restricts Access to Avandia
Date:9/24/2010

as suspended marketing of the drug, forcing patients to find another drug to control their blood sugar. The suspension will remain in place unless there is new data showing that the benefits of the drug outweigh its risks.

Avandia is also sold in combination with other diabetes drugs, with metformin under the brand name Avandamet or with glimepiride under the brand name Avandaryl, the FDA noted.

Avandia belongs to a class of drugs known as thiazolidinediones and is intended to be used along with diet and exercise to control blood sugar in patients with type 2 diabetes.

The FDA has also ordered GlaxoSmithKline to form an independent group of scientists to review the company's clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared with standard diabetes drugs. During the agency's review of the trial, questions came up about bias in identifying cardiovascular events.

"We believe this review will provide additional clarity about this trial and the safety of rosiglitazone," Hamburg said.

As published, the RECORD trial did not show any cardiovascular risk from Avandia, Dr. Janet Woodock, director of the FDA's Center for Drug Evaluation and Research, said during the press conference.

However, "at this time we cannot rely on these results," Woodock said.

In addition, the FDA stopped the company's current trial, called TIDE. This trial compares Avandia with Actos and with standard diabetes drugs. "This study does not meet the criteria for safety studies at this time," Hamburg said.

After the review of the RECORD trial is completed, the FDA may choose to take additional action, officials said.

Dr. Ellen Strahlman, GlaxoSmithKline's chief medical officer, said in a statement that "our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the U.S. have all the information they need to help them understand how
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