Panel splinters on what to do about Avandia

A splintered panel of advisers to the U.S. Food and Drug Administration recommended Thursday that the agency modify an extra warning on the type 2 diabetes drug Avandia, made by pharmaceutical giant GlaxoSmithKline.

Thirteen of the 26 panelists voted to keep the extra warning, which refers to increased risk of heart attack, with modifications, but there was little consensus on how to change the warning. Seven voted to remove it. Five voted to keep it as is. One voted to withdraw approval of the drug completely.

Avandia generated more than $3 billion in sales in 2006 for Glaxo, which is based in London but has facilities in and around Philadelphia. But Avandia's use fell dramatically after reports surfaced in 2007 that the drug caused heart problems and the FDA applied a so-called black box warning to the official label. European regulators pulled the drug from the market.

While financial analysts no longer bother to ask about the drug because sales are so small, Avandia remains a cause of consternation in the pharmaceutical regulatory community.

The FDA was criticized internally and externally for its initial approval in 1999 and for its current reassessment following several more studies of existing clinical trials. A recent re-examination of the most controversial clinical trial suggested there was less cause for concern.

"I feel we are still dealing with a cardiovascular safety signal," said panelist Susan Heckbert, a medical doctor and professor at the University of Washington who voted to keep the warning as is.

"I think this drug is severely needed," said panelist Charles Stanley, a pediatrician at Children's Hospital of Philadelphia and a professor at Penn's Perelman School of Medicine.

FDA Commissioner Margaret Hamburg, like her predecessors, is not required to follow advisory committee recommendations but usually does.

In 2012, Glaxo paid $3 billion in penalties to the U.S. government and pleaded guilty to three criminal charges, one related to withholding safety information about Avandia in the early 2000s.

The FDA, not the company, initiated the latest re-examination. But Glaxo said Thursday it would work with the FDA on possible modifications to Avandia's label so the drug's availability would be less restricted.

"We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling," James Shannon, Glaxo's chief medical officer, said in a statement.