Gilenya Side Effects Being Reviewed by European, U.S. Regulators

European regulators have placed Gilenya, Novartis’s multiple-sclerosis drug, under review due to potential links to heart problems.

The European Medicines Agency (EMA) announced on Friday that it has begun a review of Gilenya side effects and benefits after reports that a patient in the U.S. died of heart problems less than 24 hours after taking the drug.

Other patients have reported heart problems from Gilenya as well, and concerns have already sparked a Gilenya investigation in the United States by the FDA.

Gilenya (fingolimod) is a Novartis drug approved in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

While the EMA conducts its review, it’s Committee for Medicinal Products for Human Use (CHMP) has told doctors to more closely monitor patients after giving them their first dose of Gilenya. CHMP recommends that doctors conduct electrocardiogram (ECG) monitoring before treatment and continue monitoring for the six hours after the patient takes the first dose.

The risk of some heart irregularities after the first dose were a concern before the drug was approved. Known side effects of Gilenya include a decrease in heart rate and/or atrioventricular conduction after the first dose. It is also known to increase the risks of developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers.

In the United States, the FDA is recommending that patients be informed Gilenya may cause serious side effects, such as a low heart rate, that can cause symptoms including dizziness, fatigue and palpitations after the first dose. The heart rate typically returns to normal within the first month of taking the drug. Patients should contact their health care provider if these symptoms occur.

The CHMP anticipates that the review into the potential Gilenya side effects will be complete by March.