Fingolimod can harm unborn baby, warns EMA

October 8, 2019 0 By FM

The European Medicines Agency (EMA) has recommended that the multiple sclerosis medicine fingolimod (Gilenya) 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 fingolimod, the medicine must be stopped, and the pregnancy will have to be closely monitored. This is because the active 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 fingolimod to ensure they are not pregnant and must use effective contraception during treatment and for two months after stopping the medicine, the agency said.

These recommendations follow a review triggered by reports suggesting that the risk of birth defects in infants who have been exposed to fingolimod 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 fingolimod were those affecting the heart, kidneys, bones and muscles.

A review of post-marketing reports data suggested that infants born to mothers treated with fingolimod during pregnancy have a two-fold increased risk of major congenital malformations compared with the rate observed in the general population (which is 2-3 %, according to EUROCAT – the European network of population-based registries for the epidemiological surveillance of congenital anomalies.

The most frequently reported major malformations in infants exposed to fingolimod in utero are congenital heart diseases (such as atrial and ventricular septal defects, tetralogy of Fallot), renal abnormalities and musculoskeletal abnormalities.

Fingolimod is a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis.