LONDON Use of an epilepsy drug developed by GlaxoSmithKline and Valeant Pharmaceuticals should be restricted to patients for whom other anti-epileptic medicines have proved inadequate or not tolerated, EU regulators said on Friday.
The European Medicines Agency said the move followed cases of abnormal coloring of the skin, nails, lips and eye tissues, including the retina, in some patients who took Trobalt.
It recommended a comprehensive eye examination should be performed at the start of treatment and at least every six months during treatment. Among 55 patients receiving Trobalt in long-term studies examined so far, 15 had retinal pigmentation, the agency added.
Abnormal coloring of the retina can result in impaired vision.
The Food and Drug Administration issued a similar warning about the drug - which is sold in the United States as Potiga - last month.
(Reporting by Ben Hirschler)