FDA Places Partial Clinical Hold on Avandia Trial

New patient enrollment into the TIDE trial halted due to concerns over cardiac risks
By Beth Gilbert
HealthDay Reporter

THURSDAY, July 22 (HealthDay News) -- The U.S. Food and Drug Administration has informed GlaxoSmithKline (GSK), the manufacturer of rosiglitazone (Avandia), that the Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial has been placed on partial clinical hold, one week after an FDA advisory panel recommended that the diabetes drug remain on the market with tightened controls or restricted sales due to cardiovascular safety concerns.

Under the partial clinical hold, enrollment of new patients into the trial will be suspended until further notification from the FDA. However, patients already enrolled will be allowed to continue with the trial. Although the drug seems to increase cardiovascular risks, the FDA advisory panel voted during the meeting, held on July 13 and 14, to keep the drug on the market because the evidence was not conclusive.

The FDA has directed GSK to update investigators, institutional review boards, and ethics committees involved in the TIDE trial about the new safety data presented at the meeting, which may be used to update existing consent information for participants currently enrolled in the trial. In a press release, GSK confirmed that they will halt new patient enrollment into the TIDE trial and will work with the TIDE steering committee to distribute a summary of the updated safety information and recent meeting deliberations.

According to a statement from the agency, "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."

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