Dear Healthcare Professionals letter about the restriction of the use of the medicinal product Trobalt (retigabine) due to the risk of discolouration of eye tissues including retina, skin, lips and/or fingernails
19.08.2013
Glaxo Smith Kline d.o.o., the marketing authorisation holder for the medicinal product Trobalt (retigabine) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) issued a letter to healthcare professionals about the restriction of indications for the medicinal product due to a risk of discolouration of eye tissues, including retina, skin, lips and/or nailfingers.
The letter is informing healthcare professionals about recent reports of discolouration and recommendations for patients monitoring.
The medicinal product Trobalt may be from now used only as an additional therapy for medicines resistant partial attacks with or without secondary generalisation, in patients with epilepsy above 18 years old, when all other appropriate medicines combination have not appeared to be adequate or have not been tolerated. Discolouration changes in the eye, including changes in the retina, have been reported in long-term clinical studies with retigabine. Blue-grey discolouration of fingernails, lips and/or skin has also been reported in the studies.
Instructions for healthcare professionals
- Patients currently treated with this medicine should be checked up regularly (not irregularly). It is necessary to re-evaluate the benefit/risk ration and inform patients about the risk of appearance of discolouration during long term treatments.
- It is necessary to perform a comprehensive ophthalmologic examination (including the sharpness of vision, slit-lamp examination and fundoscopy) in the beginning and at least every 6 months thereafter during the treatment period. Patients who have been treated with retigabine, should be called for an ophthalmologic examination.
- If discolouration changes in the retina or in the vision occur, the treatment with Trobalt may only be continued after a careful re-evaluation of the benefit/risk ratio has been carried out. Also, in patients who develop a discolouration of fingernails, lips or skin, the treatment with Trobalt may be continued only after a careful re-evaluation of the benefit/risk ratio
The new information has been included in the Summary of Product Characteristics for all strengths of Trobalt.
Here you may view the Dear Healthcare Professional letter.
HALMED has not received any report to discolouration changes related to the use of retigabine. HALMED will continue to monitor the safe use of retigabine and will promptly inform the public about any new safety information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
