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GlaxoSmithKline Plc (GSK)’s anti-seizure drug Potiga now carries a black-box warning in the U.S. on risks including potential vision loss.

The warning, the most serious type the U.S. Food and Drug Administration issues, underscores risks of abnormalities in the eye, vision loss and skin discoloration, all of which may become permanent, the FDA said in a statement today. The revised label comes after the risks were flagged by the FDA in April.

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