Statement On FDA Placing Hold On TIDE Safety Trial

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 23 Jul 2010 - 5:00 PDT

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The U.S. Food and Drug Administration (FDA) informed GlaxoSmithKline (GSK), the manufacturer of rosiglitazone (Avandia), that the postmarketing safety trial known as TIDE 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, but patients already enrolled in the trial will be allowed to continue to participate. The partial hold was implemented so that GSK can carry out FDA-mandated updates to TIDE investigators, institutional review boards (IRBs), and ethics committees regarding new safety information presented at the FDA Advisory Committee meeting on July 13 and 14, 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 American Diabetes Association, The Endocrine Society and the American Association of Clinical Endocrinologists feel that this announcement by the FDA is specific to the ongoing conduct of the TIDE trial, and suggests patients and health care professionals not over-generalize this announcement to the use of Avandia in clinical care. The FDA will be commenting on the use of Avandia in clinical practice in the future. We urge patients who have questions or concerns about their diabetes medications to discuss this with their health care team, and not to stop medications unless instructed to do so by their team.

Source:
American Diabetes Association
Endocrine Society
AACE

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