Europe and U.S. Issues New Warnings on Gilenya

Although U.S. and European health regulators have supported the continued use of the multiple sclerosis (MS) pill Gilenya, last week they announced that the drug needed to carry stronger warnings on risks of serious adverse effects on the heart.

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) launched an investigation into the safety of Novartis AG’s drug earlier this year after it was linked to 11 deaths. The EMA says that physicians should not prescribe Gilenya to patients who have a history of cardiovascular and cerebrovascular disease or people on heart-rate lowering medications.

Both agencies recommend that all patients receiving the drug should have an electrocardiogram (ECG) and a blood pressure measurement before the first dose and after the initial six-hour period, according to Reuters.

"With these risk-minimization measures in place, the committee concludes that the benefits of Gilenya continue to outweigh the risks," the EMA said in a statement.

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