The European Medicines Agency (EMA) has recommended that the multiple sclerosis (MS) medicine fingolimod (Gilenya) must not be used in pregnant women and in those able to conceive who are not using effective contraception.
The new restrictions follow a review of available data triggered by post-marketing reports suggesting 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 of 2-3 per cent.
The most frequently reported major malformations in infants exposed to fingolimod in utero are congenital heart diseases, renal abnormalities and musculoskeletal abnormalities.
The EMA recommends that all women of childbearing potential are informed of the risk of harmful effects to the foetus associated with fingolimod treatment. Patients should be given a pregnancy test before treatment initiation and effective contraception should be used during treatment and for two months after treatment discontinuation. Fingolimod treatment should be stopped two months before planning a pregnancy.
If a woman becomes pregnant during treatment, the drug must be discontinued and the pregnancy should be closely monitored, the EMA says.
Updated educational materials to help counsel patients about the risk of reproductive toxicity will be made available.