Avandia Trial Put on Hold at FDA Request

WASHINGTON, July 21 (UPI) — U.S. Food and Drug Administration officials said Wednesday the FDA has put on hold a study comparing the diabetes drug Avandia with an alternative drug.

The Thiazolidinedione Intervention with Vitamin D Evaluation, known as the TIDE trial, was ordered by the FDA in 2007, after a study suggested an increase in cardiac risk, especially in those with heart failure. The trial was to compare the Avandia to Actos, a similar medication.

The FDA advisory panel met for two days last week and voted to keep the drug on the market but with warnings included on the label and possibly restrictions to some patients.

The drug’s maker, GlaxoSmithKline, confirmed it will suspend enrollment of new patients at the request of the FDA, pending the agency’s review of recommendations from its advisory committee. The trial was to include 16,000 participants and about 1,300 had been recruited so far.

Patients already enrolled in the trial may continue, the statement from GlaxoSmithKline says.

“This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the committee’s recommendations,” Dr. Ellen Strahlman, the chief medical officer at GlaxoSmithKline, says in a statement.

Patients with questions about the use of Avandia should talk with their physicians, Strahlman says.

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