Glaxo’s Anti-Seizure Drug Gets ‘Black-Box’ Warning on Eye Risks

Pharmaceutical giant, Glaxo-SmithKline’s anti-seizure drug, Potiga, now carries a black-box warning in the United States regarding risks that include potential loss of vision.

Black-box warnings are the most serious warnings issued by the U.S. Food and Drug Administration (FDA).  On October 31, 2013, the FDA approved changes to the drug label of Potiga (ezogabine), underscoring risks of abnormalities to the retina of the eye, potential loss of vision, and skin discoloration; all of which may become permanent. The label has been revised since being flagged by the FDA in April. The revised label includes the new, boxed warning because of the risk of abnormalities to the retina, which is a part of the eye that is needed for vision.

It is advised 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.

Patients should have their eyes examined prior to starting Potiga and every six months during treatment, the FDA said. The drug accounted for 7 million pounds ($11 million) of the London-based company’s sales last year and is projected to bring in 39.5 million pounds this year, according to analyst estimates complied by Bloomberg.

“In light of these reported adverse events, we have worked closely with regulators to update the medicine’s labeling to restrict its’ use to those patients where other appropriate medicine combinations have proved inadequate or have not been tolerated,” Glaxo said in an e-mailed statement. “We review the safety of our medicines on an ongoing basis.”

If you or a loved one have taken the anti-seizure medication, Potiga, and experienced adverse side effects, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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