Posted: 07-22-10 Categories:
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FDA Avandia news on TIDE: New patients barred

The attorneys at no longer are accepting new Avandia cases.

A week after a panel of experts came within 5 votes of recommending an Avandia recall Instead, the FDA issued a “partial clinical hold” barring new patients from enrolling in a diabetes drug safety study until further notice from the FDA. Avandia side effects data and the advisory panel’s opinions currently are under review.

The study, known as the TIDE trial, is designed to compare the heart side effects risks of GlaxoSmithKline’s Avandia (generic name rosiglitazone), and Takeda’s rival diabetes drug Actos (generic name pioglitazone). Diabetics already enrolled in the TIDE trial are permitted to continue participate.

According to a press release issued today by GlasxoSmithKline, “GSK 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.”

“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 Dr. Ellen Strahlman, GSK’s Chief Medical Officer according to the release. “We are committed to working with the FDA in the best interest of diabetic patients.”

We will continue to provide the latest FDA Avandia news as it becomes available. Contact us for the latest information and news about Avandia lawsuit settlements.

The attorneys at no longer are accepting new Avandia cases.

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