Gilenya Increased Risk of Major Congenital Malformations Such As Renal / Kidney And Musculoskeletal Abnormalities, Atrial Septal Defects
On December 19, 2019 Health Canada issued a Dear Healthcare Professional Letter, "GILENYA (fingolimod) - Risk of Congenital Malformations", which warned about certain birth defects associated with Gilenya. The Key Messages part of that document 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 goes on to provide the following more detailed information:
Available human data (post-marketing data and pregnancy registry information) supported by animal data suggest that use of GILENYA is associated with an increased risk of overall major congenital malformation (approximately 5%) when administered during pregnancy in comparison with the prevalence observed in the general population (2-4%).
... [A]n increased prevalence of the following specific major malformations was noted:
- congenital heart disease such as atrial septal defects;
- renal abnormalities; and
- musculoskeletal abnormalities.
The Contraindications, Warnings and Precautions, and Consumer Information sections of Canadian Product Monograph (CPM) for GILENYA has been updated to include the new contraindication and new safety information regarding the risk of congenital malformations.
This Gilenya label change mandated by Health Canada in December 2019 comes after some earlier drug safety regulatory actions in Europe.
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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", which begins with this Gilenya pregnancy warning:
EMA has recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception.... This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects....
These recommendations follow a review triggered by reports suggesting that the risk of birth defects in infants who have been exposed to Gilenya 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 Gilenya were those affecting the heart, kidneys, bones and muscles.
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", which had this summary at the start:
Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.
In connection with those actions by European drug safety regulators, Novartis Pharmaceuticals UK Ltd. sent out a Direct Healthcare Professional Communication titled "Gilenya ▼ (fingolimod) – New contraindication in pregnant women and in women of childbearing potential not using effective contraception".
As an aside, one wonders why there has been no FDA action regarding this Gilenya birth defects issue and why there has been no "Dear Doctor Letter" about pregnant women using Gilenya sent out by Novartis Pharmaceuticals Corporation in the US as of this date (i.e., December 19, 2019).
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.
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