European Agency Recommends Increased Monitoring with First Dose of Gilenya

The European Medicines Agency (EMA) announced today that it has started a review of Gilenya (fingolimod) in response to reports of potential heart issues associated with the first dose of this drug. The EMA is responsible for the scientific evaluation of medicines developed for use in Europe, similar to the Food and Drug Administration (FDA) in the United States. According to a press release issued today by the EMA, “The review was started following reports of heart problems in patients taking Gilenya, as well as the death of one patient in the United States less than 24 hours after the first dose. The exact cause of this patient’s death is still unexplained.”

The EMA is advising doctors in the European Union to “intensify cardiovascular monitoring” following the initial dose of Gilenya. Readers should note that (1) this advisory does not apply to doctors in the United States and (2) no changes will be made to Gilenya’s labeling at this time.

According to the EMA press release, “While the review is ongoing, the Agency’s Committee for Medicinal Products for Human Use (CHMP) is advising doctors to increase their level of monitoring of patients after the first dose of the medicine. This includes electrocardiogram (ECG) monitoring before treatment and then continuously for the first six hours after the first dose, and measurement of blood pressure and heart rate every hour. After six hours, any patients with clinically important heart-related effects, such as bradycardia (a slow heart rate) or atrioventricular block (a problem with the conduction of electricity in the heart), should continue to be managed and monitored until their condition has improved.”

This advisory on the monitoring of patients taking a first dose of Gilenya, is being made prior to a final recommendation from the EMA, which is expected in March 2012. The FDA is reviewing the same data and will make any recommendations once its review is complete. For more information, please see MSAA’s article, Gilenya News Update. Readers may also visit the EMA’s website to view the press release, “European Medicines Agency starts review of Gilenya (fingolimod).”