FDA positive on Potiga safety, but calls for observational study

Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the US Food and Drug Administration has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling.

However, to further explore any potential long-term consequences of these pigment changes, FDA has required the Potiga manufacturer, UK pharma major GlaxoSmithKline (LSE: GSK), to conduct a long-term observational study. The FDA approved Potiga as adjunctive treatment of partial-onset seizures in patients aged 18 years and older in 2011 (The Pharma Letter June 13, 2011).

Modification of REMS not necessary at present