Reuters: Regulatory News: EU agency calls for curbs on GSK, Valeant epilepsy drug

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

EU agency calls for curbs on GSK, Valeant epilepsy drug May 31st 2013, 09:44 LONDON | Fri May 31, 2013 5:44am EDT LONDON May 31 (Reuters) - 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 colouring 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 colouring 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.

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions