FDA WARNS OF SEIZURE MEDICATION RISKS

May 24, 2013

On April 26, 2013, the Food and Drug Administration (FDA) issued an alert to patients and health care providers concerning the drug ezogabine (Potiga), a drug approved in 2011 as adjunctive therapy for patients 18 and over who suffer from a type of epileptic seizures called partial-onset seizures.

The alert warned about blue skin discoloration, mostly around the lips and nail beds of fingers or toes, but also potentially the face and legs. It also warned of possible pigment changes in the whites of the eyes and in the retina. Importantly, retinal abnormalities have been seen in patients even without the skin discoloration.

The FDA noted that although it is not yet known whether the pigment changes in the retina can affect vision, several patients with these changes have reported vision problems.

Read the complete safety alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm349847.htm

It is important for patients prescribed ezogabine to have a baseline eye exam before starting the drug and periodic eye exams thereafter. These exams should include visual acuity testing and a careful check of the retina. Photographs of the retina also should be taken. Other more specialized eye tests may be appropriate, as determined by an ophthalmologist.

If you are taking ezogabine and develop any vision changes or skin discoloration, you should contact your primary health care provider immediately. You should not stop taking ezogabine suddenly, as that could cause life-threatening medical problems.

Report any adverse effects related to ezogabine to the FDA MedWatch program.