After a review of the latest evidence of Gilenya’s safety aspects, the EMA (European Medicines Agency) recommends that healthcare professionals reduce the risk of heart problems, in association with the multiple sclerosis medicine Gilenya (fingolimod), by not prescribing the drug to patients with a history of cardiovascular and cerebrovascular disease or those who take heart-rate lowering medication.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends that patients’ that are deemed necessary to receive Gilenya should have their heart activity monitored for a minimum of one night after taking the first dose of Gilenya, and that doctors should seek advice on appropriate monitoring from a cardiologist.

The new recommendations also include that all patients who start Gilenya therapy should have their heart activity monitored prior to taking the first dose and continuously for a minimum of six hours afterwards, whilst those whose heart rate is lowest six hours after receiving the first dose should be monitored for at least two hours extra. Patients developing considerable clinical heart problems like bradycardia (low heart rate) or atrioventricular (AV) block, a conductivity problem in the heart, should be monitored at least overnight and until the problems have been resolved.

Since March 2011, Gilenya, the first disease-modifying MS treatment available as an oral formulation, has been authorized in the EU to treat relapsing-remitting MS in patients who failed to respond to beta-interferon therapy, or whose disease is severe and rapidly worsens.

Since the initial authorization, it has been known that Gilenya may cause transient bradycardia, a short lowering of the heart rate, and may also be linked to heart rhythm disorders related to AV block, and the product information warns about these risks.

After receiving information of a patient’s unexplained sudden death – within 24 hours of taking Gilenya for the first time – the agency reviewed Gilenya’s cardiovascular safety in January 2012, at which time the CHMP issued temporary recommendations and advised doctors to perform ECG monitoring six hours after taking the first dose with a possible extension.

The CHMP reviewed all available data on the heart safety of Gilenya, which included reports of 15 incidents of sudden or unexplained death in patients who took Gilenya. They observed the majority of deaths and cardiovascular problems had occurred in patients with a history of cardiovascular problems or those who took other medications but the data proved inconclusive in terms of Gilenya being the cause of deaths. The CHMP also observed that in most patients, Gilenya produced the highest impact of lowering the heart rate within six hours after taking the first dose and noted that, if necessary, the bradycardia can be reversed by administering atropine or isoprenaline to the patient.

According to the CHMP, the possible risk of heart problems in patients who take Gilenya could be reduced further, by reinforcing the medicine’s existing warnings on cardiovascular effects and ensuring close monitoring of all patients. The CHMP concludes that by implementing these measures Gilenya’s benefits still outweigh its risks.

Written By Petra Rattue