FDA review reinforces possible Avandia risks
WASHINGTON — A federal drug official dealt a severe blow to the popular diabetes drug Avandia yesterday, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.
The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.
Such repeated mistakes “should not be found even as single occurrences’’ and “suggest serious flaws with trial conduct,’’ Marciniak wrote.
The detailed report could prove crucial next week, when a panel of experts will meet to consider whether to recommend to the FDA that the manufacturer,
The panel’s decision will have broad consequences for the company, the FDA, and perhaps the process by which medical products are approved. The agency almost never does clinical trials on its own, depending on drug companies to conduct them.
Avandia, which helps patients get better control of blood sugar levels, has already come under intense criticism. It has been shown to increase the risks of bone fractures and to cause swelling that can lead to heart failure and eye problems.
And a number of studies, including some by GlaxoSmithKline, suggest that it could increase the risks of heart attacks, strokes and death. But the company has relied heavily on the major clinical trial, nicknamed Record, to demonstrate that those risks are exaggerated.
Marciniak’s review is part of a reassessment of Avandia’s safety by FDA medical officers to educate the panel, who will meet Tuesday and Wednesday in Gaithersburg, Md., to advise the agency whether Avandia should be withdrawn — after millions of prescriptions, billions of dollars in sales, and 11 years of wide use.
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