EMA has recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception. If a woman becomes pregnant while using Gilenya, the medicine must be stopped and the pregnancy will have to be closely monitored. This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects.
To minimise 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.
These recommendations follow a review triggered by reports suggesting that the risk of birth defects in infants who have been exposed to Gilenya during pregnancy is twice as high as the 2 to 3% risk observed in the general population. The most frequently reported birth defects in infants exposed to Gilenya were those affecting the heart, kidneys, bones and muscles.
Doctors, patients and carers will receive updated educational materials with information about this risk and what actions and precautions need to be taken to ensure the safe use of Gilenya.