The Food and Drug Administration criticized the maker of Avandia, GlaxoSmithKline, for failing to report clinical data and threatened to take regulatory action against the company if it does not correct the violation.
FDA Posts Letter
According to a letter posted on the FDA website, Glaxo omitted post-marketing information about the drug in reports to the agency. The letter refers to Glaxo’s violations as “serious” and possibly “symptomatic of underlying post-marketing safety reporting failures.”
The FDA said the omitted data wasn’t discovered until last year during an inspection.
Avandia Heart Attack Risk
In May 2007, a report was published in the New England Journal of Medicine linking Avandia to an increased risk of heart attack. The drug was a top-selling diabetes medication but sales have since dropped sharply.
(Source: Triangle Business Journal)
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