A large study to test the safety of the drug against the controversial Avandia diabetes has been partial hold by the Food and Drug Administration. The FDA held a hearing on the safety of Avandia last week. Some scientists argue that persistent drug, if modestly, increasing the risk of heart attacks in patients with diabetes. But other scientists and the drug manufacturer, GlaxoSmithKline, dispute these results. The TIDE trial was designed to dispel lingering doubts about the drug, but it would take at least 6 years. And today, the FDA informed Glaxo that it was not allowed to enroll new patients in TIDE, although already enrolled patients may continue.
Science will report on the TIDE trial July 23 in number, which appears online tomorrow.
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