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European Health Regulatory Agency Recommends Restrictions on Epilepsy Drug Trobalt

Jun 3, 2013

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended restricting the epilepsy medication Trobalt (retigabine) because of side effects, including impaired vision.

The EMA now recommends that physicians prescribe Trobalt, developed by Valeant Pharmaceuticals and GlaxoSmithKline, only to patients for whom other epilepsy medicines are not effective or who cannot tolerate other drugs. The agency made this recommendation after evaluating cases of abnormal pigmentation of the skin, nails, lips, and retinas, in patients taking part in long-term studies. Of 55 patients in the studies who have been examined so far, 15 had retinal pigmentation, and about one-third of them had impaired vision. The impairment was mild in all but one patient, the agency said. Almost all cases of retinal pigmentation occurred after two years of treatment, the EMA reports.

The U.S. Food and Drug Administration (FDA) issued a similar warning about the drug last month, according to Reuters. The drug is sold in the United States under the brand name Potiga.

The CHMP recommends that patients have a comprehensive eye examination before starting Trobalt and every six months during treatment, and patients should report any skin discoloration that develops while they are taking the drug.

Because Trobalt has a different mechanism of action than other anti-seizure medications, the EMA explains, it could be useful for patients who are not helped by, or cannot tolerate, other epilepsy medications. Physicians and patients must carefully weigh the benefits and risks of Trobalt treatment.

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