This December 2019 Health Canada warning about Gilenya birth defects, ” “GILENYA (fingolimod) – Risk of Congenital Malformations”, starts with these two points:
- When used during pregnancy, GILENYA (fingolimod) has been associated with an increased risk of major congenital malformations, including congenital heart disease such as atrial septal defect, and renal and musculoskeletal abnormalities.
- GILENYA is now contraindicated in women who are pregnant or in women of childbearing potential who are not using effective contraception.
This December 2019 Health Canada warning about Gilenya birth defects comes after some earlier drug safety regulatory actions in Europe.
First, in July 2019 the European Medicines Agency (EMA) published this document, “Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy”.
Second, in September 2019 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, “Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception”.
We will continue to monitor this developing drug safety issue involving Gilenya birth defects, specifically the increased risk of major congenital malformations, including congenital heart disease such as atrial septal defect, renal / kidney abnormalities, and musculoskeletal abnormalities.[Read article in full at original source]