FDA issues new contraindications for fingolimod following death

Excerpt

The death of a patient, within 24 hours of receiving a first dose of Gilenya [fingolimod], triggered the US FDA to re-evaluate the cardiovascular (CV) safety of the multiple sclerosis drug.* While the agency could not definitively conclude that the use of Gilenya was related to this patient’s death, or any of a number of other deaths reported in patients receiving the drug, it remains concerned about the HR-lowering effects of Gilenya, and now contraindicates the drug’s use in patients with certain pre-existing or recent heart conditions or stroke, and in patients who are taking certain antiarrhythmic medications. …