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FDA Approves Revised Warnings on Anti-seizure Drug’s Label

Filed November 1st, 2013 Laurie

The U.S. Food and Drug Administration (FDA) announced that it has approved changes to labeling for the anti-seizure medication Potiga (generic: ezogabine) to underline previously reported risks for retinal abnormalities, potential vision loss, and skin discoloration, all of which may become permanent.

The FDA gave the drug its most warning, a black-boxed warning, because of the risk for retinal abnormalities. The agency noted in its statement: “We advise that Potiga use be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.”

The agency is recommending that patients undergo eye examinations that include visual acuity and dilated fundus photography before starting Potiga, and every six months during treatment, with vision testing as necessary. The FDA warned that patients who cannot have their vision monitored regularly should not take Potiga.

Other conditions mentioned on the revised label include potential side effects such as discoloration of the skin, nail, mucous membrane, and white of the eye, all of which were first outlined in the FDA’s previous statement about this drug’s side effects, in April. All of the recommendations have been added to the label’s Warnings and Precautions section, and the patient Medication Guide.

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