EPILIM Birth Defects

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Epilim – The harmful side effects of the epilepsy drug for pregnant women

Campaigners have stated the vital importance of any women or girls that are taking an epilepsy drug that causes birth defects, should be automatically reviewed by specialists to see if an alternative can be provided.

Epilepsy Ireland has said that any new child patients should not be put on the drug Epilim by their doctor, in order to avoid them having to wean off it themselves and find a replacement in the future when they may want to start a family.

Epilim is the brand name for sodium valproate in Ireland and in recent years has been implicated in 40 cases of disabilities and birth defects as reported to the Health Products Regulatory Authority (HPRA). However, campaign groups believe that this may not be a true number and that it is possible that there may be 400 cases over the 43 years that the drug has been used here.

The European Medicines Agency is conducting a review of is expected to announce new restrictions or procedures for the use of Epilim. Following on from this review, it is then expected that the HPRA will convene a meeting of patient groups, pharmacists and doctors and other relevant parties in order to agree fresh protocols for the use of Epilim in Ireland.

Warnings about possible birth effects have been presented on Epilim packaging leaflets for years, but became more explicit in 2014 and since last year, extra warnings are also carried on the outer packaging of the product.

In 2016, HSE figures show that 1,700 female patients between the age of 16 and 44 were prescribed with Epilim. Various medical conditions in babies were reported by women in Ireland who took the drug during pregnancy. These included tumours, spina bifida, foetal malformation, autism and developmental problems and cerebral palsy. Also several women reported spontaneous abortions. Babies exposed to the drug in pregnancy have a 30-40% risk of serious developmental disorders along with an 11% risk of congenital malfunctions.

Since 2014, the HPRA has said that it has worked to provide information about Epilim through as many media as possible, including packaging, patient alert cards and front-line workers.

“The HPRA has communicated extensively with neurologists, obstetricians, paediatricians, psychiatrists, GP’s, family planning clinics, specialist epilepsy nurses, pharmacists and HSE clinical leads.

An Irish woman has given evidence at a hearing in London about the harmful effects of an epilepsy drug on her children. The lady from the Foetal Anti-Convulsant Syndrome Forum addressed to European Medicines Agency (EMA) on Tuesday at a hearing regarding the drug sodium valproate. The EMA is in the process of reviewing which measures are needed in order to warn women of the risks of the drug, particularly if taken during pregnancy. During the hearing, experts also highlighted that warnings over the drug (which has harmed thousands of children worldwide) should have been made as far back as the 1970’s. Sanofi (the manufacturer of the drug) has said that it has always been transparent with regulators about the risks of the medicine. Various campaigners have questioned the decision to not publish warnings about sodium valproate despite these warnings being highlighted by the manufacturer. Documentation from 1973 show that British regulators decided not to warn patients directly of the risks for fear it “could give rise to fruitless anxiety”. The license issued in 1974 for Epilim said that doctors and pharmacists should only prescribe it in severe cases of epilepsy or where there was no other alternative.

A representative from the UK’s Epilepsy Scoeity has said that women need to be given the right information and to make an informed choice. She went on to state that the charity wanted to see a national register created for any women taking the drug.



The Right to Life of the Unborn v The Right to Terminate in circumstances of Fatal Foetal Abnormality

Four CourtsThe Right to Life of the Unborn v The Right to Terminate in circumstances of Fatal Foetal Abnormality

The Right to Life of the Unborn is a right protected by Art.40.3.3 of the Constitution which provides;

“The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable,by its laws to defend and vindicate that right.”  

The above passage has been interpreted as meaning that the court, in determining a matter before it, will endeavour to strike a balance between the right to life of the unborn child and the right to life of the mother.

However, earlier case law in this area demonstrates that this was not always achieved, as seen in the cases of Attorney General (Society for the Protection of Unborn Children (Ireland) Ltd v Open Door Counselling [1988] and Society for the Protection of Unborn Children (Ireland) Ltd v Grogan [1989] wherein SPUC successfully sought interlocutory injunctions restraining the defendants from distributing information about abortion services and facilities in the UK to women resident in Ireland. These decisions were later overturned under EU law and the Freedom to Provide Services under Art 56 of the Treaty on the Functioning of the European Union, however they remain reflective of the approach that was taken to abortion at that time; that it is prohibited in Ireland, and that it should not be encouraged or advertised within the State by agents outside of this jurisdiction.

The well-known case of Attorney General v X [1992] brought the issue of permissibility of abortion to the forefront, where the right to life of the mother was undoubtedly given more consideration. In this case, the right to life of the mother was given due weight under circumstances where it was shown that there was a real and substantive risk that the mother would commit suicide given the circumstances under which she had fallen pregnant. The Supreme Court in this case ruled that the threat posed to the mother’s life was enough to necessitate the need for an abortion to be permitted in this instance, and that the mother should be allowed to travel to the UK to obtain an abortion. This case therefore demonstrates that the termination of a pregnancy is permitted in Irish law where there is a real and substantial risk to the life of the mother.  The 1992 Thirteenth and Fourteenth Amendments to the Constitution now prevent Art.40.3.3 to be relied upon to stop a mother travelling to another jurisdiction to receive an abortion, and indeed from availing of information relating to such services, demonstrating a development in this area of the law in more recent years. The Protection of Life During Pregnancy Act 2013 has since been enacted to give statutory effect to the above ruling.

However, a question arises as to whether a mother should be allowed to terminate a pregnancy under circumstances where they have been advised that their unborn child is suffering fatal abnormalities, rendering their chances of survival outside of the womb as non-viable. This issue was addressed in the case of D v The Health Service Executive [2007] wherein the mother’s first ante-natal scan tragically confirmed that the foetus suffered from anencephaly, a condition that resulted in the child being unable to survive upon birth. It was held in this case that the mother had the right to travel to the UK for the purposes of having an abortion. However, the law remains that abortion cannot be carried out in Ireland, merely providing the possibility for women to travel to another jurisdiction to have same carried out.

As it stands, a mother carrying a child with a diagnosis that their child is suffering from a condition or illness that renders them unable to survive outside of the womb will be assisted in delivering stillbirth, however will be unable to terminate the pregnancy prior to reaching this distressing stage.

It appears that little has been done to change this area of the law, as demonstrated by the recent defeat of the Fatal Abnormalities Bill in the Dáil this month. The Bill proposed to permit the termination of pregnancies where fatal abnormalities had been detected in Ireland, however this was rejected by 95 votes to 45.