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| English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia) |
Glaxo's anti-seizure drug Potiga now comes with a black box warning. A boxed warning, sometimes called a black box warning, is an alert that sometimes appears on the package insert for certain drugs. It is the strongest warning the FDA requires and signifies that medical studies indicate that the drug carries significant risk of serious or life threatening adverse effects.
The label chance was announced today after risks were flagged in April. The warning identifies abnormalities of the eye, vision loss and skin discoloration, all of which may become permanent.
