EMA: Gilenya Must Not Be Used in Pregnant or Fertile Women Not on Birth Control

The EMA has determined that pregnant and fertile women not on birth control should steer clear of Novartis’ multiple sclerosis (MS) drug Gilenya (fingolimod).

The agency said that women who become pregnant while taking the medicine must cease all use of the drug and have their pregnancy closely monitored, as its active substance can harm the baby and cause birth defects.

“To minimize this risk, women able to have children must have a pregnancy test before starting treatment with Gilenya to ensure they are not pregnant, and must use effective contraception during treatment and for two months after stopping the medicine,” the EMA advised.