The federal Food and Drug Administration (FDA) has ordered GlaxoSmithKline, the makers of controversial diabetes medication Avandia (rosiglitazone), to stop enrolling patients in its head-to-head comparator trial with Actos (poglitazone).
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Last week, an expert panel that convened to advise the FDA on the safety of Avandia voted 19-11 to keep the trial going and voted 20-12 to keep the drug on the market, despite ongoing safety concerns about the increased risk of cardiovascular events as associated with the drug.The TIDE trial was initiated in 2007, at the request of the FDA, following an earlier advisory panel meeting over the safety of Avandia.
Briefing documents released in advance of last week's advisory committee meeting reportedly contain remarks by FDA reviewer David Graham, MD, who called the trial "unethical and exploitative" because the primary purpose of the trial is to look for a safety signal for Avandia.
The FDA will make a ruling in the fall as to whether or not Avandia will be allowed to remain on the market. With respect to the TIDE trial, the FDA has said that patients enrolled in the study can remain on study if they wish.