FDA Statement on Avandia TIDE Trial
ROCKVILLE, Md., July 22, 2010--The U.S. Food and Drug Administration today informed GlaxoSmithKline (GSK), the manufacturer of the diabetes drug Avandia (rosiglitazone), that the postmarketing trial known as TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) has been placed on partial clinical hold.
Under the partial clinical hold no new patients may be enrolled into the trial until further notice from the FDA. Patients already enrolled in the trial will be allowed to continue to participate.
The FDA has instructed GSK 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.
This information can be used by investigators and IRBs to update existing informed consent information for current trial participants.
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.
Posted: July 2010