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MS Drug Gilenya Under Investigation After U.S. Patient Dies

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The Multiple Sclerosis drug Gilenya is currently under investigation by the European Medicines Agency after reports of heart problems in patients in Europe and the death of one patient in the U.S. arose. Apparently, these health problems occured in the patients within 24 hours of receiving the drug. The FDA also announced on December 20 last year that it was looking into the death of the U.S. patient.

Gilenya can temporarily slow the heart rate and although this usually returns to normal within a few hours, European officials want doctors to more closely monitor the heart after first use of the drug. This would include electrocardiogram monitoring before treatment and then for six hours after administering the drug, in addition to monitoring the blood pressure and heart rate.

The maker of the drug, Novartis, says it is investigating whether Gilenya caused the death of the 59-year-old U.S. patient. The FDA noted that the cause of death is still unclear, although if more heart problems continue to occur with the use of the drug, doctors will be less likely to continue administering it to their patients. Currently, more than 30,000 people have been given the drug worldwide.