According to the U.S. Food and Drug Administration (FDA)’s most recent announcement, two potential side effects of Potiga, first mentioned by the agency in April 2013, are irreversible. Specifically, the FDA has revealed that Potiga can damage the retina of the eyes, potentially leading to permanent blindness, and can also cause permanent discoloration of the skin.
In an attempt to underscore potential side effects of the drugs, the FDA has called for a revised label that includes the agency’s black-boxed warning, the most serious warning the agency can provide. “We advise that Potiga use 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,” the FDA said in a press release.
FDA Black-Box Warning Stresses the Potential Dangers of Potiga
The FDA approved Potiga for the treatment of partial seizures, the most common type of seizure experienced by epileptics. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. In general, seizures can cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness.
Initially, the most common adverse reactions linked to Potiga in clinical trials included: dizziness, fatigue, confusion, spinning sensation (vertigo), tremor, problems with coordination, double vision, problems paying attention, memory impairment, lack of strength, and double-vision. Potiga was also known to cause urinary retention, or difficulty in emptying the bladder fully, and other possible side effects.
Then, in April 2013, there was a sudden leap in interest in the drug as the FDA issued a safety communication to warn the public that Potiga could cause blue skin discoloration as well as eye abnormalities characterized by pigment changes in the retina. The FDA admitted at the time that it did not know if the changes were reversible. All patients taking Potiga, the agency noted, should have a baseline eye exam, followed by exams. The FDA noted at the time it was going to continue evaluating the drug.
The present news regarding the black-box warning is confirmation of the worst case scenario, as conceived by the FDA back in April; the drug can cause side effects that are irreversible.
FDA’s Recommendations for Those Still Taking Potiga
The FDA recommends that patients have eye exams by an ophthalmic professional before starting Potiga and every six months during treatment. These exams should include visual acuity and dilated fundus photography, with additional vision testing as necessary. Patients whose vision cannot be monitored should generally not take Potiga.
As for the risk of discoloration of the skin (and nail, mucous membrane, and white-of-the-eye), the updated Potiga drug label states that if a patient develops skin discoloration, an alternate medication should be considered. The patient medication guide also now says this.
Legal Help for Patients Who Have Taken Potiga
If you or a loved one took the prescription drug Potiga, and have suffered from blindness or skin, please fill out our online form or contact one of our experienced personal injury lawyers today at 1(800)-YOURLAWYER (1-800-968-7529).