GSK counters FDA claim of withheld Avandia safety information

Washington According to the Food and Drug Administration, GlaxoSmithKline failed to properly disclose studies about its diabetes drug Avandia, but a spokeswoman for the pharmaceutical company said none of the withheld information raised new concerns about potential safety risks.

Avandia has been under fire for about the last year, after it was linked to a 43 percent increased risk of heart attacks

The violations “are serious and may be symptomatic of underlying post-marketing safety reporting failures,” the FDA said in a letter posted today on its Web site. The agency said it was never told about nine studies and an additional 11 weren't included in required annual reports from 2001 to 2007.

“Of the studies that were actually omitted from the FDA in any type of reporting, those studies did not show safety events,” GSK spokeswoman Nancy Pakerek said. “The information that the FDA needed was provided to them before [the agency changed the prescribing information.]”

The FDA found unreported research while inspecting paperwork at GSK's offices in Research Triangle Park, North Carolina from August to November, according to the letter, after reports of side effects from the drug.