FDA warns GlaxoSmithKline for not reporting safety studies of diabetes pill Avandia

[Celebration]

http://www.iht.com/articles/ap/2008/04/08/america/FDA-Warning-Glaxo.php

Federal regulators have issued a warning to GlaxoSmithKline for not reporting safety results on its diabetes pill Avandia, which received a prominent warning label last year.

The Food and Drug Administration said that between 2001 and 2007 the drug maker did not annually update the agency on more than 10 ongoing studies of Avandia, as required by regulations.

While the agency acknowledges information from the studies was disclosed in other notices, the omissions "are serious and may be symptomatic of underlying post-market reporting failures."

The FDA said it had no record of nine other studies until last September, when Glaxo provided a corrected version of its 2007 update on Avandia.

FDA posted the warning letter, dated March 25, to its Web site Tuesday.