Black Box Warning for Potiga Reviewed Again by FDA

Black Box Warning for Potiga Reviewed Again by FDA
Black Box Warning for Potiga Reviewed Again by FDA

The Food and Drug Administration (FDA) has determined that the Boxed Warning for Potiga (ezogabine; GlaxoSmithKline) is adequate to manage the potential risks of vision loss due to pigment changes in the retina and skin discoloration.

In 2013 the FDA approved changes to the Potiga drug label on the risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration that may become permanent. The FDA has required GlaxoSmithKline to conduct a long-term observational study on the potential long-term consequences of these pigment changes; the agency anticipates that this will provide additional information on whether pigment changes in the retina caused by Potiga can lead to vision loss or other long-term side effects, and the relationship between pigment changes in the retina and skin discolorations.

RELATED: Risk of Vision Loss Prompts FDA to Update Anti-Seizure Drug Labeling

Potiga is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged ≥18 who have responded inadequately to several alternative treatments and for whom the benefits outweigh the risk of retinal abnormalities and potential decline in visual acuity.

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