The European Medicines Agency, the agency responsible for the scientific evaluation of medicines for use in the European Union, has undertaken a review of Gilenya following cases of serious cardiac events and death in patients who had recently started the medicine. As yet, there is not enough information to determine if Gilenya was the cause of these cases, which is why a review is underway. During the review, the agency has strengthened its recommendations for monitoring patients who receive the drug.
The new guidelines are as follows:
Before starting treatment with Gilenya, all patients should have their heart checked by ECG, a test that measures the electrical activity of the heart.
After receiving the first dose of Gilenya, all patients should have their heart function continuously monitored by ECG for six hours.
All patients should also have their blood pressure and heart rate checked every hour for six hours after the first dose.
If patients develop any clinically relevant heart problem (such as bradycardia or atrioventricular block), doctors are advised to consider extending the monitoring period until it is resolved.
These guidelines apply only within the European Union. FDA guidelines within the U.S. remain unchanged. Those being treated or planning to begin treatment who have questions can call Novartis, the drug's manufacturer, at 1-888-NOW-NOVA.