FDA issues black box warning for seizure drug Potiga over vision loss, skin discoloration

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by John Chapman

The Food and Drug Administration has issued a “black box” warning for the anti-seizure drug Potiga (ezogabine) due to a risk of potentially irreversible vision loss and skin discoloration. The FDA warning about Potiga involves the 50 mg, 200 mg, 300 mg, and 400 mg formulations of the drug. Due to the risk of vision loss associated with Potiga, the FDA has recommended that the drug only be used with patients who have been unsuccessfully treated with several other seizure medications and for whom benefits of the drug outweigh the risk of vision loss.

According to the FDA warning, Potiga may cause eye abnormalities involving pigment changes in the retina. In clinical trials of Potiga, retinal pigmentary abnormalities were observed in approximately one-third of patients who had been taking the drug for four years or longer. In some cases, Potiga users who experienced pigment changes in their retinas also suffered from loss of vision. The FDA stated that it is unclear whether vision loss associated with Potiga is reversible.

Some patients taking Potiga have also experienced skin discoloration after using the drug. In most cases, skin color changes associated among Potiga users resulted in a blue discoloration, although grey-blue or brown discoloration has also been reported. Skin discoloration occurring among patients taking Potiga was observed predominantly around the lips or in the bed of the fingernails or toenails. However, more widespread skin discoloration in the face or legs has also been reported.

The FDA has advised patients taking Potiga to undergo vision testing every six months in order to check for pigment changes that may be a sign of serious vision problems. If retinal pigmentary abnormalities or other vision changes are detected, the FDA has advised that treatment with Potiga should be discontinued unless there are no alternative treatments available.

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