Glaxo Failed to Disclose Avandia Studies, FDA Says

-Bloomberg

04/08/2008- GlaxoSmithKline Plc, Europe's largest drugmaker, failed to properly disclose studies of the diabetes pill Avandia after it was linked to potentially deadly side effects, U.S. regulators said.

Glaxo didn't tell regulators about certain trials before last year and disclosed other research, although not in the proper reports, according to a warning letter posted today on the Food and Drug Administration's Web site. Patients' reports of side effects appear to have prompted the studies, the FDA said.

U.S. sales of Avandia dropped by half last year after a May 21 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks, prompting U.S. and European regulators to add new warnings to the product's prescribing information. The FDA discovered unreported research during an inspection of London-based Glaxo's U.S. facilities from August to November, according to the warning letter.

``The specific violations noted in this letter are serious and may be symptomatic of underlying post-marketing safety reporting failures,'' the FDA wrote.

Glaxo lost 37 pence, or 3.3 percent, to 1,103 pence in London trading at 3:05 p.m. local time. The drugmaker had fallen 20 percent in the 12 months before today.

The company has taken steps to improve its processes and train its employees to ensure that appropriate data is sent to the FDA from now on, Glaxo spokeswoman Nancy Pekarek said. None of the studies that were kept from the FDA raised new concerns about potential safety risks, she said.

``Of the studies that were actually omitted from the FDA in any type of reporting, those studies did not show safety events,'' Pekarek said today in a phone interview. ``The information that the FDA needed was provided to them before they made their label.''

If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Avandia's side effects, a possible Avandia class action lawsuit, or any other type of Avandia litigation.