MHRA limits retigabine indications

on the 1 August 2013

The MHRA has limited the use of the adjunctive anti-epileptic treatment retigabine (Trobalt) to patients with partial onset seizures with or without secondary generalisation where other appropriate drug combinations have proved inadequate or have not been tolerated.

The ophthalmic examination required when prescribing retigabine (Trobalt) should include a visual acuity test, dilated fundoscopy and a slit -lamp examination (pictured) | SCIENCE PHOTO LIBRARY

The decision to restrict retigabine (Trobalt) was based on reports of adverse effects in long-term studies, including pigmentation of the skin, nails, lips and ocular tissues (including the retina).

Warn patient and perform eye examination before starting

When initiating therapy, healthcare professionals should inform patients of the risk of pigmentation with long-term treatment and perform a comprehensive ophthalmological examination before starting treatment and at least every 6 months thereafter.

Patients currently receiving retigabine should be identified and reviewed at a routine appointment. In addition, they should have an appointment scheduled for an ophthalmic examination.

MHRA Drug Safety Update July 2013

View Trobalt drug record

Further information: GlaxoSmithKline

Follow MIMS on Twitter