MS Drug Gilenya Under Review in Europe, but Still Deemed Safe by FDA

US medical professionals are continuing to back Novartis’ Gilenya (fingolimod) despite the growing concern following several cases of patient death in the past few months. To investigate the effects of Gilenya on one’s cardiovascular health, the European Medicines Agency (EMA) has launched a review of the drug and made some preliminary recommendations with regards to current treatment. The U.S. Food & Drug Administration (FDA), however, is still hesitant to make any definitive claims. “We have not made any determinations about what regulatory actions, if any, are necessary, and have not yet determined whether any new monitoring recommendations are necessary,” said an FDA spokesperson to the Financial Times. According to the EMA, Gilenya has been administered to approximately 30,000 patients worldwide.

Concerns first arose over the Gilenya back in December 2011, when a patient died within 24 hours of receiving their first treatment. The exact cause of death remains undetermined. Since then, there have been an additional 10 cases of death among patients taking Gilenya, six of which were unexplained and several others linked to disruption of heart rhythm. Gilenya has also been associated with cases of macular edema, a condition that causes swelling in the eye, and subsequently vision problems.

The drug is the first oral medication prescribed to treat symptoms in patients with multiple sclerosis (MS), an autoimmune disease affecting one’s central nervous system. Essentially, the body’s immune system attacks myelin sheaths, the fatty substance facilitating nerve conduction. In the US, Gilenya is typically recommended to patients with relapsing-remitting MS (RRMS). RRMS is an early stage of the disorder, and is often characterized by acute episodes of neurological impairment, referred to as “exacerbations”. The European Union, however, appears to have stricter recommendations; it is approved for patients who exhibit severe symptoms despite beta interferon injections or for those whose condition is rapidly worsening.

In response to the recent events, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has encouraged doctors to closely monitor patient conditions, particularly after administering the first dose, which should take place inside the doctor’s office. Patients starting Gilenya should expect to undergo an electrocardiogram (ECG) prior to, and the six hours following, the first dose. Warning signs such as a slowed heart-rate (bradycardia) will warrant additional monitoring until conditions are stable.

Although these recent developments seem unnerving, some clinicians feel that there is not enough evidence to cease using Gilenya. Since it is still relatively early in the investigation, professionals have not determined whether or not the deaths were caused by the drug. Professor of neurology at Mt.Sinai School of Medicine and well-known MS clinician Dr. Aaron Miller told the Financial Times that “the EMA recommendation is perhaps premature.” He pointed out that only one case closely followed the first bout of treatment.

The EMA plans to reach a more comprehensive and conclusive view by mid-March, but as of right now, the FDA is still supporting the use of the drug and instructing medical professionals to pay close attention to the approved label. Patients are not advised to stop treatment without first consulting their physician.

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