European Medicines Agency Commences Safety Review of Gilenya
January 20, 2012
The European Medicines Agency (EMA) has started a review of the oral medication Gilenya® (fingolimod, Novartis) after reports issued on January 20 that there have been 11 deaths among patients who received treatment. Our sympathies go out to the families of all of these individuals. As more information becomes available, we will release it as soon as possible to the MS community.
This review is in addition to the investigation currently underway way by the U.S. Food and Drug Administration. Health Canada has also announced a review of the situation. The FDA review was referenced in this statement released by them in December concerning a patient who died within 24 hours of receiving a first dose of the oral medication Gilenya.
Although few details of these unfortunate incidents under investigation have been released, many appear to be related to cardiac events. Until more information is available about the circumstances of these deaths, it is not possible to know what role Gilenya may have played. According to company reports, more than 33,000 patients have received this new oral therapy to date.
While the EMA review proceeds, they recommend that doctors prescribing Gilenya in Europe increase patient monitoring after the first dose is given. The recommendations include “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.” The FDA has not made any recommendations for changing how patients in the U.S. are monitored after receiving their first dose.
Articles on these events are being reported in various media outlets.
“We look forward to results of these agencies’ reviews,” said Dr. Timothy Coetzee, chief research officer at the National MS Society, “because understanding the benefits and risks of therapies is vitally important to everyone in the MS community.”
Individuals who have questions about Gilenya’s safety should contact the Novartis patient support line at 888-NOW-NOVA (888-669-6682) or the individual’s prescribing doctor.