Government
FDA: Glaxo holds studies on Avandia
By Sue Mueller
Apr 8, 2008 - 1:55:49 PM

TUESDAY April 8, 2008 (foodconsumer.org) -- GlaxoSmithKline Plc failed to report all the required studies on its diabetes drug Avandia to the Food and Drug Administration, the agency said in a warning letter released on Tuesday.

Avandia was linked to increased risk of heart attack and a black box warning, the highest level of warning, was required on the label in November.

The company said at the time the FDA made its decision, the agency had received all the data.

In the letter dated March 25 and posted on the agency's website on Tuesday, the FDA said an inspection from August through November 2007 revealed Glaxo did not list a number of post-approval studies of Avandia as required.

"The specific violations in this letter are serious and may be symptomatic of underlying post marketing safety reporting failures," the FDA was cited as saying in the letter.

Nancy Pekarek, GlaxoSmithKline spokeswoman, said the omissions were unintentional and the missing data did not raise any new safety concerns about the diabetes drug Avandia.

According to the FDA, nine studies were not disclosed until September 2007. Also 11 other studies were not included in required annual reports although they were given to the agency in other ways.

The missing data, the company was cited as saying, included the start, progress and final data from some trials. But the omissions "did not interfere with the timely reporting of adverse event information to the FDA", Glaxo Chief Medical Officer Ronald Krall said.

The FDA required a black box warning for Avandia because the medicine may increase the risk of heart attack.