Image from FDA.gov
Published: Apr 29, 2013
By Cole Petrochko , Staff Writer, MedPage Today
WASHINGTON — The FDA has warned consumers that the anti-seizure drug ezogabine (Potiga) can cause skin and eye discoloration.
Use of the drug may cause blue skin discoloration on or around the lips, in nail beds on fingers and toes, and potentially on the face and legs. Discoloration on the white of the eye and inside the eyelids has also been reported, the agency said in a safety communication Friday.
The seizure treatment may also induce pigment changes in the retina, which may result in serious eye disease with loss of vision, the communication cautioned.
Ezogabine is an adjunctive therapy for partial-onset seizures in adult patients.
It is not known if these changes are permanent or if the retinal pigment changes caused by use of the drug can lead to vision problems. The skin discoloration generally occurred after 4 years of treatment with the drug, according to the FDA, but has appeared earlier in some patients. In some instances, retinal abnormalities have been noted without accompanying skin discoloration.
The FDA recommended that patients taking ezogabine, or who are about to start treatment with the drug, receive an eye examination and periodic examinations afterward. Patients who experience decreased visual acuity or skin discoloration should cease using the drug unless there are no alternative medications.
However, patients should not cease use of the drug without consulting a healthcare professional, as halting use of anti-seizure drugs can precipitate withdrawal seizures, which can be fatal, the FDA warned.
The agency is conducting an ongoing investigation into the cause of these adverse events with drug manufacturer Valeant Pharmaceuticals of Quebec.