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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.


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Lyndy Cantillon



Lyndy qualified as a Solicitor in 2014 and since then has been working in the medical litigation department at Cantillons. Lyndy has worked extensively in cases involving birth injuries, cancer misdiagnosis, surgical errors and fatal claims. Lyndy works hard and as a result of this has had great success in this field. Lyndy understands the physical and mental stress her clients have been through before they come to Cantillons with their query and she encourages her clients to leave their stresses with her.

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Lyndy achieved a Bachelor of Arts degree at University College Cork with a degree in Art History and Italian. Thereafter she went on to study for the FE1 entrance examinations and successfully passed all eight exams. Lyndy took an apprenticeship at Cantillons and got experience in general litigation, medical litigation, probate and commercial litigation. Lyndy qualified as a Solicitor on 2014 and has been working in the medical litigation department since then.

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