FDA staffer seeks higher standards after Avandia concerns

By Kim Dixon

WASHINGTON (Reuters) - A U.S. Food and Drug Administration official called for higher safety standards in approving diabetes drugs in the aftermath of fears about links between a top diabetes drug and heart attack risk.

The safety of GlaxoSmithKline's Avandia and other diabetes drugs was thrust into the spotlight after a New England Journal of Medicine analysis in May linked Avandia to a 43 percent increase in risk of having a heart attack.

Now, the FDA medical reviewer of Glaxo's original application for Avandia is calling for experimental diabetes drugs to be tested against existing drugs, instead of the traditional method against a placebo, that official wrote in the December issue of the journal Diabetes Care, released on Tuesday.

"You can't really evaluate a drug in a vacuum; you have to evaluate it in comparison to something," Dr. Robert Misbin, a medical officer in the FDA unit that reviews diabetes drugs, said in an interview.

Avandia had sales of more than $3 billion last year, but sales have slipped to rival Actos made by Takeda Pharmaceutical Co amid the controversy.

According to the World Health Organization, about 180 million people worldwide suffer from some form of diabetes, a condition where the pancreas can't produce enough of the blood-sugar regulating hormone insulin, or can not use effectively what it produces.

The FDA has since added its strongest labeled warning to Avandia, while lawmakers have criticized the agency for minimizing safety concerns about the drug.

An FDA panel of experts earlier this year voted to keep Avandia on the market, despite the risks, saying the evidence was too thin to halt sales. FDA took that advice, but earlier this month added a "black box" warning of the studies suggesting risk.