CHMP recomends heart monitoring for Gilenya (Novartis) patients

The CHMP has reviewed Gilenya (fingolimod) from Novartis,following the unexplained sudden death in a patient within 24 hours of taking the drug . The CHMP recommends that Gilenya should not be prescribed for patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication. When treatment is considered necessary in these patients, their heart activity should be monitored at least overnight following the first dose and doctors should seek advice from a cardiologist on appropriate monitoring. The CHMP also recommends that all patients starting treatment with Gilenya should have their heart activity monitored before receiving the first dose and continuously for at least six hours thereafter.