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FDA Halts Enrollment In Avandia Safety Trial
By Scott Hensley
Updated: 4 years ago

A big safety study that drugmaker GlaxoSmithKline hopes will answer, or at least neutralize, questions about the heart risks of diabetes drug Avandia just hit another bump.

The Food and Drug Administration told Glaxo to stop signing up patients for the study called TIDE, short for Thiazolidinedione Intervention With Vitamin D Evaluation. Patients already in the study -- looking at heart effects of Avandia and the rival drug Actos -- can stick with it.

In the best case for Glaxo, the stoppage will be temporary and let researchers, their institutions and ethics boards digest the outcome of the recent meeting that ended with a vote in favor of continued sale of Avandia, though with beefed-up warnings and restrictions.

"It's the ethically correct thing to do," longtime Avandia critic Dr. Steven Nissen told the Associated Press. "It was the only decision the FDA could have made."

But the FDA is now deciding how to handle Avandia, and the agency could overrule the advisory panel and push Glaxo to withdraw the medicine from the market.

For its part, Glaxo reiterated in a statement that it will work with the FDA "in the best interest of diabetic patients."

Last month Indian authorities put a hold on the TIDE study in that country, citing safety concerns. [Copyright 2010 National Public Radio]