FDA warns anti-seizure drug may cause skin discoloration, vision loss

The FDA has announced that there are potential vision loss risks because of pigment changes in the retina and possible skin discoloration for patients treated with the anti-seizure drug Potiga, according to reviews of additional safety data.

By following the current recommendations on Potiga (ezogabine, GlaxoSmithKline), the risks can be adequately managed, the FDA announced in a press release. The FDA has mandated GlaxoSmithKline to conduct a long-term observational study of ezogabine to examine possible long-term consequences of the pigment changes, the release stated.

Ezogabine is indicated for use in combination with other anti-seizure drugs to treat partial-onset seizures in adults who respond inadequately to several alternative therapies or when the treatment benefits outweigh the risks, according to the release.

There was no indication that retinal pigment changes experienced by some patients affected their vision, the release said. Serious adverse events did not appear to be associated with the skin discoloration, according to the FDA.

“FDA expects that the required long-term observational study will provide further information on whether pigment changes in the retina caused by ezogabine can lead to vision loss or other long-term side effects,” the release said. “In addition, the study should provide more information on the relationship between pigment changes in the retina and skin discoloration.”

Health care professionals should continue to follow the boxed warning, according to the release.

The FDA is encouraging health care workers and patients to report adverse events or side effects related to the use of ezogabine to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.

Reference: www.fda.gov