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Restrictions for use of Gilenya (fingolimod) medication for Multiple Sclerosis during pregnancy to prevent birth defects

Posted in [Blog General Legal Tips Medical Negligence New Legal Developments ] on Wednesday, August 7th, 2019

Gilenya (fingolimod) is a medication used and licensed to treat adults and children over the age of 10 years with multiple sclerosis (MS). It is manufactured by Novartis and available in Ireland when prescribed by a Consultant Neurologist.

It belongs to a class of medication known as a disease-modifying therapy and use is reserved for treating patients who suffer with more severe MS who suffer periodic flare ups of symptoms (known as highly active relapsing-remitting MS), generally after other treatments have not worked.  Many patients throughout Ireland benefit from this medication.

However as of the 26th July 2019, the European Medicines Agency has advised that Gilenya (fingolimod) is not safe for use during pregnancy.  Women of child bearing potential must use effective contraception.
These restrictions have been issued based on data which suggests 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.  The most frequently reported major malformations in infants exposed to fingolimod in utero are congenital heart diseases, renal abnormalities and musculoskeletal abnormalities.

All women of childbearing potential should immediately be informed of the risk of harmful effects to the foetus associated with fingolimod treatment. To minimise the risks, the recommendation is that:

• Gilenya (fingolimod) should be stopped two months before planning a pregnancy,
• Women should then be given a pregnancy test before beginning treatment and
• Effective contraception should be used whilst taking the medication and for two months after treatment has been discontinued.
• If a woman becomes pregnant during treatment, the drug must be discontinued and the pregnancy should be closely monitored, the EMA says.
It is unknown how many women and their babies are at risk in Ireland.

In Ireland, the impact of the use of Thalidomide during pregnancy still affects a large number of victims.  We have also seen delays in the manner in which the HSE reacted to recommendations to restrict the use of Epilim (sodium valproate) in pregnancy, which, when taken during pregnancy is known to be linked to developmental disability and birth defects.  We have also seen delays by the HSE and the State in adequately compensating these victims.

It is important therefore that all medical practitioners, patients and carers are made aware of the risks with Gilenya (fingolimod) during pregnancy and take the appropriate steps immediately.  This would be in keeping with the HSE’s policy of open disclosure and more importantly will hopefully avoid any further damage to the health of infants.


Contact us at Cantillons Solicitors at +353 (0)21 -4275673 or if you would like more information.

* In contentious business, a solicitor may not calculate fees or other charges as a percentage of any award or settlement.

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Ernest J. Cantillon

Managing Partner

Orla Kelly


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