Posted: 09-25-10 Categories:
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FDA stops Avandia TIDE trial due to unjustified heart risks

The attorneys at no longer are accepting new Avandia cases.

The FDA Avandia trial required by the ordered TIDE trial has
been stopped by the agency as part of its September 23, 2010, regulatory action on Avandia. FDA drug safety experts concluded that the TIDE trial subjected participants to an unjustified risk of heart disease. All of the regulatory deadlines set by the FDA for completion of the trial have been rescinded.

In 2007, after the FDA drug safety advisory committee meeting on Avandia, the FDA required Avandia manufacturer GlaxoSmithKline (GSK) to perform a study comparing the heart disease risks its TZD diabetes drug Avandia (rosiglitazone) to rival TZD Actos (pioglitazone) and standard diabetes drugs. To meet this requirement, GSK started the ‘Thiazolidinedione Intervention With Vitamin D Evaluation” (TIDE) trial.

Since the study began, more evidence has become available linking the use of Avandia to an increased risk of heart attack, stroke, congestive heart failure and heart related death. Because of the serious health risks to study participants and recent FDA actions on Avandia, proper informed consent became an issue. Participants would need to be informed of:

  • the risk that Avandia may cause more cardiovascular disease than alternative TZD Actos
  • the new restrictions on Avandia use imposed by the FDA
  • that it is unlikely that the patient would receive Avandia outside the study

According to recent recommendations from the National Academy of Sciences Institute of Medicine (IOM) committee, such an informed consent process might be justified only if the study’s outcome could realistically yield a significant benefit to public health. The FDA currently does not consider TIDE such a study.

As a result, the FDA required the TIDE trial be stopped.

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