The U.S. Food and Drug Administration (FDA) recently approved changes to the drug label to the anti-seizure medication Potiga. The new warning will alert patients and doctors to the risk of severe retinal pigment changes that can lead to blindness. The label will also warn that the Potiga has been linked with skin discoloration, particularly of the hands, feet and lips.
The revised label includes a new black box warning about retinal abnormalities and potential vision loss. Black box warnings are the most serious type of warning that the FDA can require a pharmaceutical company to place on the labeling of a prescription drug. The FDA found that Potiga’s “risk of abnormalities to the retina, a part of the eye that is needed for vision,” necessitates such a high alert to healthcare professionals and patients alike. The agency stated that it will continue to modify the Risk Evaluation and Mitigation Strategy for Potiga to address the risks of retinal pigmentary abnormalities, potential vision loss, and skin discoloration.
Potiga Risks Reported Six Months Before Warnings Issued
The recent warning was a supplement to a FDA Drug Safety Communication that was released in April 2013, finding that several reports were received of blue skin discoloration on the lips, hands, and feet, in patients using Potiga. There were also reports of changes in the color of the retinas of some patients, which can lead to blindness. All of these side effects may become permanent, according to the FDA.
As a result, the FDA is recommending that Potiga only be prescribed to patients after safer alternative drugs have been used and failed, and then only if the benefits of treatment outweigh the risks. Additionally, all patients taking Potiga should undergo baseline and periodic eye exams. The FDA states that patients who are taking Potiga and develop any changes in their vision or any discoloration of their skin, including of their lips and nail beds, should contact their health care professional immediately.
Potiga was developed by Valeant Pharmaceuticals and GlaxoSmithKline. Potiga is an anti-seizure medication that was approved in June 2010 for the treatment of partial onset seizures in adults 18 years of age and older with epilepsy.
The attorneys at Lopez McHugh have earned a national reputation for drug and medical device litigation. If you or a loved one has suffered retinal abnormalities or skin discoloration from Potiga, please contact our team for a free legal consultation.