Patients with certain cardiovascular conditions should not take the multiple sclerosis drug fingolimod, and all patients starting the drug require careful monitoring for cardiac adverse events, according to the US Food and Drug Administration (FDA).
Based on analysis of the sudden unexplained death of 1 patient and reports of cardiovascular adverse events, including some deaths in other patients, the FDA concluded it could not determine whether fingolimod caused these events (http://tinyurl.com/d2zazcd). However, the agency expressed its concern about the cardiovascular effects of the drug, particularly the first dose. According to the FDA, the drug may lower the heart rate, with the greatest effect occurring during the first 6 to 20 hours of first use.
Kuehn BM. Fingolimod Precautions. JAMA. 2012;307(24):2578. doi:10.1001/jama.2012.7064