Potiga Lawsuit Lawyer
Please note: Our law firm no longer accepts Potiga cases.
Potiga, a seizure epilepsy medication manufactured by GlaoxoSmithKline (GSK), can cause blindness and other eye and skin problems. If you or a loved one has been injured by Potiga, contact an experienced Potiga Lawyer for a free legal consultation regarding a potential Potiga Lawsuit against the drug’s manufacturer.
Black Box Warning
The U.S. Food and Drug Administration (FDA) has warned the public that the anticonvulsant drug ezogabine – sold under the brand name Potiga in the U.S. and Trobalt elsewhere – might cause eye abnormalities and skin discoloration.
On October 31, 2013, the FDA announced it had approved a change to Potiga’s label. This included a black-box warning – the agency’s most serious – for retinal abnormalities, potential vision loss, skin discoloration. The warning states the rate of a given symptom’s progression and its reversibility is unknown.
All these problems could be permanent. Therefore, the FDA advises Potiga be limited “[to] patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.”
Potiga can cause Eye, Skin Problems
On April 26, 2013, the FDA issued a drug safety communication regarding Potiva, advising the public that Potiga had been found to cause previously undocumented side effects. Some users reported blue skin discoloration in different places, including:
- Nail beds
- Fingers or toes
Some reported that Potiga changed the color of their sclera and conjunctiva – the whites of the eyes and inner eyelids. Eye discoloration sometimes occurred without the skin discoloring.
Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities, pigment changes in the retina. The agency is working with the drug’s maker to gather and evaluate all available information to better understand the adverse events.
Pigment changes in the retina can cause eye disease with vision loss.Whether the retinal pigment changes can lead to visual impairment is not known, though several patients have reported impaired vision. In some cases, retinal abnormalities have occurred without skin discoloration. Skin discoloration in reported cases has appeared as blue pigmentation, mostly on or around the lips or in the nail beds of the fingers or toes. Changes in the face and legs have also been reported, along with scleral and conjunctival discoloration, in the whites of the eyes and inside eyelids. Skin discoloration usually occurred after four years of treatment with Potiga, but it has appeared sooner in some.
Potiga is approved as an adjunct for other anti-seizure medications in the treatment of partial-onset seizures in adults 18 and older. 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.
FDA: Get an Eye Exam
The FDA recommends that anyone taking Potiga should have a full-scale eye examination. The agency also advises against stopping use of Potiga without supervision from a health care professional. Abruptly ceasing treatment can cause life-threatening medical problems such as a recurrence of seizures.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety. See the FDA Announcement.
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. 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 can’t say if more were affected and failed to report it.
We will keep you up to date on any Potiga class action lawsuits, additional FDA Potiga warnings, and Potiga FDA recall announcements.