The US Food and Drug Administration has ordered GlaxoSmithKline (GSK), maker of the controversial diabetes drug Avandia, to halt enrollment in the TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) trial, designed to compare the cardiovascular safety of Avandia to that of the diabetes drug Actos in people with Type 2. This decision comes a week after an FDA advisory panel voted to allow Avandia to remain on the market, but with a majority of the panelists calling for label revisions and restrictions on the drug.
Under the partial clinical hold, no new participants may be enrolled in the trial until further notice from the FDA, but those who are already enrolled will be allowed to continue to participate. The trial, which was requested by the FDA, is being conducted by an independent research group and aims to study 16,000 people in 14 countries before the year 2015. As of last week, about 1,100 people had volunteered for the trial.
The FDA has instructed GSK to update researchers, review boards, and ethics committees involved in the trial with regard to safety data and votes from last week’s meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Committee. (The panel voted 19–11 in favor of keeping the trial open if Avandia remains on the US market.) This new information could be used to revise the informed consent forms for those currently enrolled in the trial.
According to an announcement on the FDA Web site, “The FDA is evaluating available information on Avandia’s safety and the discussions of the recent advisory committee meeting. The FDA will update the public on the outcome of its review and its implications for Avandia and the TIDE trial when the review is complete.”
In a joint statement, the American Diabetes Association, the Endocrine Society, and the American Association of Clinical Endocrinologists noted that the FDA’s announcement is specific to the TIDE trial, and urged people with questions about their diabetes treatment to speak with their health-care providers.
For more information, see the article “FDA Orders Enrollment Freeze on Rosiglitazone Trial” or see the statement posted on the FDA’s Web site.