The European Medicines Agency (EMA) has begun a review on Gilenya (Fingolimod) after reports of heart problems after the first dose. One patient in the US also died within 24 hours of the first dose, although the cause of death has not been confirmed.
Patients currently undergo a six hour monitoring period after the first dose of Gilenya as a slow heart rate was noted during trials. The EMA is now advising doctors to intensify their monitoring of patients after the first dose is administered. This includes an increase in the number of times a patient’s heart rate and blood pressure is taken and the inclusion of an ECG during the monitoring period.
In March of 2011 the EMA authorised Gilenya in the European Union for MS patients who do not respond to beta-interferon or who have a highly active disease. In Ireland Gilenya has not been reimbursed by the HSE yet and therefore less than 100 people are on the treatment. These patients received the therapy as part of a trail or under a compassionate use programme.
If you have any queries about the therapy, consult your neurologist.
Read the EMA’s press release
Read the EMA’s fact sheet on the review