FDA Links Potiga to Retinal Abnormalities and Blue Skin Discoloration

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FDA Links Potiga to Retinal Abnormalities and Blue Skin Discoloration

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The U.S. Food and Drug Administration (FDA) issued a Safety Communication warning the public that the anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina.

Currently, the FDA does not know if these changes are reversible. The agency recommends that all patients taking Potiga have a baseline eye exam, followed by periodic eye exams. The FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. The agency will update the public when more information is available.

Pigment changes in the retina, one of the side effects of Potiga, has the potential to cause serious eye disease with loss of vision. While several patients have been reported to have impaired visual acuity after taking Potiga, it is currently unknown whether the retinal pigment changes caused by Potiga lead to visual impairment.

In reported cases, skin discoloration appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes. However, more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has also been observed.

Skin discoloration is reported to occur after four years of treatment with Potiga, but has appeared sooner in some patients. In some cases, retinal abnormalities have been observed in the absence of skin discoloration.

The FDA suggests that all patients taking Potiga or those considering taking Potiga should have an eye exam, followed by periodic eye exams thereafter. Potiga should be discontinued if ophthalmic changes are observed unless no other treatment options are available. If a patient develops skin discoloration, serious consideration should be given to changing to an alternate medication.

According to the FDA, patients should not stop taking Potiga or any anti-seizure medication without talking to their health care professional, as stopping anti-seizure treatment suddenly can precipitate withdrawal seizures, a serious and life-threatening medical problem.

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