New safety advice for Gilenya in Europe
The European Medicines Agency (EMA) has recommended that Gilenya (fingolimod) must not be used by pregnant women or women able to have children who are not using effective contraception.
The changes to the safety recommendations for the multiple sclerosis medicine come after a review triggered by post-marketing reports of birth defects.
The reports suggested that infants who have been exposed to Gilenya during pregnancy were at an elevated risk of birth defects, twice as high as the 2%-3% risk observed in the general population.
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