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EMA recommends restrictions in the use of Trobalt

03 June 2013

The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommends restricting the use of the epilepsy medicine Trobalt® (retigabine) to only those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.

The recommendation follows long-term studies which reported cases of blue-grey pigmentation of the nails, lips and skin as well as eye tissues, including the retina (the light sensitive layer of the eye). These changes were reported in patients who were treated long-term with retigabine, typically for more than two years. Retinal pigmentation could possibly lead to impaired vision.

Trobalt® was authorised in 2011 as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy.

It is estimated that around 60 patients were treated with Trobalt® in Denmark in 2012.

Patients who are taking Trobalt® must not stop taking the medicine without talking to their doctor. Stopping treatment may put patients at risk of seizures (fits).

Doctors must follow the new recommendations for Trobalt®. This implies, among other things, that Trobalt® must only be used in drug-resistant patients after a careful evaluation of benefits and risks and that patients must be monitored at routine eye examinations.

Please find more information about the recommendations on the EMA website.

Neurologists and eye specialists in Denmark will also be informed in a letter which the marketing authorisation holder of Trobalt® will send within the next weeks.