More FDA troubles for Avandia

WASHINGTON The Food and Drug Administration wants GlaxoSmithKline to add a “black box” warning about risks of a heart-attack to the label of its diabetes drug Avandia, according to people with knowledge of the matter as reported by the WallStreetJournal.com.

This would hurt business for the drug even more. Avandia and Actos already carry a label warning about heart failure, but the heart-attack risk would only apply to Avandia, which is GSK’s second biggest selling drug, as of last year.

No statement has been issued yet by the agency or the company, but according to a spokeswoman for the company, GSK is “working diligently with the FDA to finalize the label, but it would be inappropriate for us to discus the ongoing conversations with the agency.”

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