EMA recommends restricting Trobalt to last-line therapy in partial epilepsy

Benefit-risk balance remains positive for patients who cannot use alternatives; restricted use is recommended due to risk of retinal pigmentation

03-Jun-2013 - United Kingdom

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of the anti-epileptic medicine Trobalt (retigabine) only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated. This follows a careful evaluation of cases of pigmentation (abnormal colouring) of the skin, nails, lips and eye tissues, including the retina (the light sensitive layer at the back of the eye) reported in patients taking part in long-term studies.

The CHMP recommended that patients currently being treated with Trobalt should be reviewed at a routine (non-urgent) appointment. The balance of benefits and risks should be re-evaluated, and patients should be informed of the latest safety information. The CHMP also recommended that a comprehensive eye examination should be performed at the start of treatment (for new patients) and at least every six months during treatment. If retinal pigment or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.

Among the 55 patients who had received Trobalt in the long-term studies and who have been examined so far, 15 had retinal pigmentation. Around one third of the 15 patients with retinal pigmentation also had impaired vision, although this was mild in all but one patient. It is currently uncertain if this impairment was present before starting Trobalt treatment, or whether it was in any way related to the pigmentation. In addition, 51 cases of blue-grey pigmentation of the nails, lips and skin have been reported in the long-term studies. At present, the nature of the colour changes and how the medicine could cause them is still being clarified.

In its assessment, the CHMP took into account not only the importance of retinal pigmentation, as it could possibly result in impaired vision, but also considered that uncontrolled epilepsy is a serious condition which may be life-threatening if left untreated. The CHMP therefore concluded that Trobalt remains a valuable alternative option for patients whose epilepsy cannot be controlled by other medicines.

https://www.bionity.com/en/news/143352/ema-recommends-restricting-trobalt-to-last-line-therapy-in-partial-epilepsy.html