What are the FDA warnings regarding use of ezogabine in the treatment of epileptic seizures?

Updated: May 30, 2019
  • Author: David Y Ko, MD; Chief Editor: Selim R Benbadis, MD  more...
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Answer

In October 2013, the FDA approved labeling changes for ezogabine, including a boxed warning, emphasizing increased risks for potentially permanent adverse effects, such as retinal abnormalities, vision loss, and skin discoloration. The agency recommended that the use of ezogabine be limited to patients who have had an inadequate response to several other therapies and in whom the treatment benefits outweigh the risks. The FDA also recommended eye examinations for patients before they start on ezogabine, as well as every 6 months over the course of treatment. [50, 51, 52]


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