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TIDE Trial on Avandia Put on Hold by FDA

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By Admin on July 22, 2010 10:14 AM

A new clinical trial on the drug Avandia has been halted. The FDA is asking GlaxoSmithKline to halt the enrolment of new participants in its study until researchers can be brought up to speed on the controversial drug's risks. Last week, an advisory committee for the FDA found that the drug Avandia, used to treat diabetes, did cause an increase in heart risks.

The FDA advisory committee reviewed the risks associated with Avandia with an eye to recommending pulling it from the market. As noted in a prior post, the final decision was to allow the drug to stay on the market, but the panel did recommend to the FDA that the Avandia label should include a warning about the increased chance of heart attack.

GSK has said in a statement that it would stop the recruitment for the study, called the TIDE trial. The company has also said it will update the study's chief investigators, but will permit those patients already committed to continue to participate. The focus of the TIDE trial is to assess whether the risk of heart events is actually greater in patients using Avandia than in those who use its main competitor, the drug Actos.

According to the AP, critics of the drug say the trial is not appropriate since evidence already shows Avandia is riskier than Actos. Actos is manufactured by the Japan-based Takeda Pharmaceuticals.

Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, is an outspoken critic of Avandia. He says holding enrollment in the TIDE trial was "the ethically correct thing to do."

"I still think there's a very good chance that the FDA will decide to remove Avandia from the market," Nissen told the AP.

At this time, only 1,000 patients are enrolled in the TIDE trials. The study was supposed to cover 16,000 volunteers. The FDA wants the TIDE researchers to use updated informed consent forms that will describe the risks of the study to potential recruits.

The FDA is expected to make a decision on whether to keep the drug on the market in coming months.

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