liver toxicity, bradycardia, heart conduction abnormalities,
macular edema, gradual decline in pulmonary function
pulmonary toxicity, serious herpes infections

The studies excluded patients with diabetes, heart conduction disorders,arrhythmias and pulmonary disease
(cardiac toxicities are of particular concern given the known effect of S1P modulation on heart rate)

The advisory panel suggested that a six hour observation period for at least the first dose be established as a condition of approval due to the cardiac problems seen in studies and that further studies are needed for people who were excluded from the studies due to the above conditions.

Like any other drug, there are risks.