FDA wants big warning on Glaxo diabetes drug

Food and Drug Administration officials are pushing for a “black box” warning on GlaxoSmithKline Plc’s hard-hit diabetes drug Avandia, the Wall Street Journal reported, citing sources.

The warning would be a further blow to the top-selling diabetes drug, which came under pressure last May when a U.S. analysis linked Avandia to a 43-percent higher risk of heart attack in patients.

Avandia already has strong warning advising of the risk of a different side effect, heart failure, the paper said. But a similar warning for the risks of heart attack would be more serious, it said.

The European Medicines Agency last week recommended a tighter label for Avandia, but said the benefits outweighed the risks of the drug and a similar one called Actos, made by Takeda Pharmaceutical Co.

Last July, an advisory panel to the FDA recommended that Avandia should stay on the market, but said it should have increased warnings.

Avandia posted global sales of $3.24 billion last year making it the company’s second-biggest seller, but sales have plummeted since the May study linking it to increased risk.

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