The Food and Drug Administration wants GlaxoSmithKline to add the strongest form of safety warning about heart-attack risk to the label of its diabetes drug Avandia, according to people with knowledge of the matter, a move that would compound the commercial woes of the once-popular medication.
Agency officials are pushing for a "black box" warning, these people say. The new label is still being discussed with the company and its final form isn't yet clear.
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Agency officials are pushing for a "black box" warning, these people say. The new label is still being discussed with the company and its final form isn't yet clear.
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Dr Rosemary Johan-Liang will, no doubt, be interested in this turn of events.
How the world turns!
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