FDA Requires Black Box Warning for GSK’s Anti-Seizure Drug Potiga® Due to Risks of Retinal Abnormalities
On October 31, 2013, the FDA issued a Drug Safety Communication informing the public that the FDA has “approved changes to the drug label of the anti-seizure drug Potiga® (ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent.” The FDA also required a new Black Box Warning, the most serious type of warning, due to the risk of abnormalities of the retina (a part of the eye necessary for vision). The FDA’s Safety Announcement also advises health care professionals that Potiga® should 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.”
On April 26, 2013, the FDA previously issued a Drug Safety Communication regarding Potiga® due to risks of eye abnormalities and blue skin discoloration. At that time, the FDA warned the public “that the anti-seizure medication Potiga® (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina” and the FDA did not know “if these changes are reversible.” The FDA reported that pigment changes in the retina have the potential to cause serious eye disease with loss of vision, while the blue skin discoloration typically occurred after four years of treatment with Potiga® and appeared predominantly on the lips or nail beds of the fingers or toes (although more widespread skin discoloration of the face and legs had been reported). The FDA provides photos of the blue skin discoloration experienced by patients taking Potiga®.
The updated label now contains warnings regarding the risk for skin discoloration associated with Potiga®, as discussed in the April 2013 Drug Safety Communication. According to the FDA, the “updated Potiga® drug label states that if a patient develops skin discoloration, an alternate medication should be considered. The FDA also announced that it is working on modifying the current Risk Evaluation and Mitigation Strategy (REMS) for Potiga® in order to evaluate and address the risk of potential vision loss, abnormalities of the retina, and skin discoloration.
Potiga® is manufactured by GlaxoSmithKline (GSK) and was approved by the FDA in June 2011 to treat partial-onset seizures in adult patients 18 years or older. Potiga® is an anticonvulsant medication that opens potassium channels in brain cells, which stabilizes the brain’s electrical system and thus reduces seizures. According to the FDA, approximately 10,900 prescriptions of Potiga® were dispensed between April 2012 and February 2013.
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