FDA suspends Avandia safety study

The Food and Drug Administration, today, ordered GlaxoSmithKline to suspend the clinical trial of its diabetes drug Avandia. The move comes a week after an FDA advisory committee met to review data on the safety of the drug, also known as rosiglitazone.

The agency said that no new patients could be enrolled in the so-called TIDE trial, although patients already in it can continue to participate. And the FDA ordered Glaxo, which has major operations in the Philadelphia area, to “update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial regarding new safety information presented at the joint FDA Advisory Committee meeting held on July 13 and 14, 2010, along with information regarding the deliberations and votes of that meeting.”


While that advisory panel voted 20 to 12 to recommend that Avandia remain on the market, a majority of the experts also recommended restrictions or new warnings on the drug because of evidence that it increases the risk of heart attacks, heart failure and stroke compared with a competing medication – Actos or pioglitazone, made by Takeda Pharmaceutical Co. of Japan.

“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,” said Glaxo’s chief medical officer, Ellen Strahlman. “We are committed to working with the FDA in the best interest of diabetic patients.

In a statement issued by the drugmaker, Strahlman added, “we believe that Avandia is an important treatment option for patients with type 2 diabetes. …Patients with questions about the use of Avandia should talk with their physicians.” 

Glaxo noted that the TIDE study (Thiazolidinedione Intervention with Vitamin D Evaluation) was mandated by the FDA to compare the cardiovascular safety of Avandia and Actos.

The company added that it will “work with the TIDE Steering Committee to send a summary of recent safety data and a summary of the FDA Advisory Committee meeting on Avandia to all TIDE investigators and Institutional Review Boards to ensure they have the latest information for patients.”

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