Monday, October 29, 2007

FDA says safety board recommends halt to Canadian-led drug trial

From the Globe and Mail:
The U.S. Food and Drug Administration has revealed that the safety board overseeing a large Canadian-led trial has recommended the trial be stopped because of concerns the drug being tested increases the risk of death.

The FDA statement says that the Data Safety Monitoring Board has recommended no new patients be enrolled in the trial.

The study, which goes by the acronym BART, is led by Ottawa researcher Dr. Paul Hebert.

It was designed to test the drug aprotinin — marketed as Trasylol by Bayer Inc. — against other drugs used to reduce blood loss during heart bypass surgery. ...more

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