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FDA Reviewer Questions Results of Key Avandia Trial
Date:7/11/2010

e American Diabetes Association meeting, found no such connection.

Next week's meeting will shed much-needed light on the matter.

When the advisory panel meets Tuesday and Wednesday, its options "range from allowing the continued marketing of Avandia and revising the label to remove the boxed warning, all the way to withdrawal from the U.S. market," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, explained at a packed news briefing late Thursday. "We're asking them to pick one, vote on it and explain the rationale."

But, according to the The New York Times, the panel will also be asked to decide whether a currrent Glaxo study comparing the safety of Avandia and Actos is ethical. The study is being done at the FDA's request.

The FDA is not bound to follow the recommendations of its advisory committees but usually does.

Much of the current controversy, Garratt said, "probably reflects dissent within FDA. They've been debating this internally for a long time. This is probably just turning up the heat on that argument."

Dr. Joshua Sharfstein, principal deputy commissioner of the FDA, told reporters on Thursday, "Obviously, we're going to have to look at a lot of information and really understand the advice that we're getting and try to make a decision as quickly as we can under the circumstances. This is an FDA decision."

Meanwhile, the European Medicines Agency announced Friday morning that it would also review Avandia's safety for use in Europe. The Associated Press reports that the review will be conducted by the agency's Committee for Medicinal Products for Human Use from July 19 to July 22.

More information

The U.S. National Library of Medicine has more on Avandia and Actos.

SOURCES: Kirk Garratt, M.D., clinical director of interventional cardiovascu
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