EMA Recommends Gilenya Not be Used in Pregnancy

July 26, 2019
Pharmaceutical Technology Editors

EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.

The European Medicines Agency (EMA) has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant or women who are able to have children and are not using effective contraception.

Issuance of this recommendation has come about as a result of the potential effect of Gilenya’s active ingredient on the unborn child. If women, who are taking the medication, become pregnant, EMA recommends the medicine be stopped immediately and the pregnancy be closely monitored.

To minimize risks, EMA advocates that women who are able to have children be administered a pregnancy test prior to the commencement of treatment. Additionally, it is recommended that women use an effective method of contraception for the duration of treatment and two months after cessation of treatment.

The recommendation has been issued as a result of a review, which was initiated following reports that there was double the risk of birth defects in infants exposed to Gilenya during pregnancy compared with the general population. Most frequent birth defects that were reported in infants exposed to Gilenya affected the heart, kidneys, bones, and muscles.

EMA stated in a July 26, 2019 press release that it will issue updated education materials with information about the risk of Gilenya in pregnancy, and the actions and precautions that need to be taken to ensure its safe use. 

Source: EMA