The U.S. Food and Drug Administration (FDA) is now warning the public that the anticonvulsant drug ezogabine—sold under the brand name Potiga in the United States and Trobalt elsewhere—might cause eye abnormalities and skin discoloration.
What Is Potiga and What Is It Prescribed For?
Potiga is an anti-seizure medication manufactured by the British pharmaceutical giant GlaxoSmithKline plc. The FDA approved it in June 2011 to treat partial-onset seizures in people aged 18 and up. Potiga works differently from other anticonvulsants because it opens potassium channels in brain cells, which stabilizes the brain’s electrical system and thus reduces seizures.
According to the FDA, between April 2012 and February 2013, roughly 2,900 people purchased 10,900 Potiga prescriptions at retail pharmacies in the United States.
Potiga Might Cause Eye and Skin Side Effects
On April 26, 2013, the FDA issued a Potiga warning in the form of a drug safety communication advising the public that Potiga had been found to cause previously undocumented side effects. Some users reported blue skin discoloration in the following areas:
- Nail beds;
- Fingers or toes;
- Legs; and
Some patients also reported that Potiga changed the color of their sclera and conjunctiva—the whites of the eyes and inner eyelids, respectively. Sometimes eye discoloration occurred without skin discoloration.
So far, the only reports of Potiga side effects have come from participants in the first Potiga clinical trials, and most cases occurred in people who had used Potiga for more than four years. Approximately 38 out of 605 (6.3 percent) study participants reported discoloration side effects, but the FDA doesn’t know if more were affected and didn’t report it. The FDA states it does not yet know if the discoloration is reversible.
On October 31, 2013, the FDA announced it had approved a change to Potiga’s label to include a black-box warning, the agency’s most serious alert, for retinal abnormalities, potential vision loss, and skin discoloration. The warning states that the rate of the symptoms’ progression and their reversibility is unknown.
RLG’s Potiga Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Potiga lawsuit on your behalf if necessary. RLG will also keep you up to date on any Potiga class action lawsuits, additional FDA Potiga warnings, and Potiga FDA recall announcements. If you or a loved one has taken Potiga, and you believe it caused an injury, contact RLG today.