Review urged as 40 women report birth defects

Women and girls taking an epilepsy drug that causes birth defects should be automatically reviewed by specialists to see if alternatives can be prescribed, campaigners say.

Epilepsy Ireland said doctors should not start any new child patients on the drug, Epilim, to avoid them having to wean themselves off it and find a replacement in future, when they want to start a family.

Epilim, the brand name in Ireland for sodium valproate, is implicated in 40 cases of birth defects and disabilities, reported to the Health Products Regulatory Authority (HPRA) in recent years. However, campaign groups believe the true number may be 400 over the 43 years that the drug has been used here.

The drug is under review by the European Medicines Agency, which is expected to announce new restrictions or procedures for its use.

It is expected the HPRA will then convene a meeting of doctors, patient groups, pharmacists, and other relevant parties to agree fresh protocols for its use in Ireland.

However, Peter Murphy, chief executive of Epilepsy Ireland, said that, in the meantime, all women and girls taking the drug should be fast-tracked through medical reviews with specialists.

“Our concern is that there are patients whose epilepsy is being controlled by Epilim, so they will have been discharged from the hospital system and are under the care of a GP, who could be prescribing the drug for 10 years or more, precisely because it works and everyone is happy with it,” said Mr Murphy.

“But, in those years, a young woman will have begun to think about having a family, and a child will have grown into a young woman, and where pregnancy wasn’t on their minds before, it will be, or should be, now.”

Warnings about possible birth effects have been carried on leaflets in Epilim packaging for years, but they became more explicit in 2014. Since last year, extra warnings are also carried on the outside of the packaging.

HSE figures show that 1,700 female patients between the ages of 16 and 44 were prescribed Epilim in 2016. Medical conditions in babies, reported by women in Ireland who took the drug during pregnancy, include foetal malformation, tumours, spina bifida, cerebral palsy, autism and developmental problems. Several women reported spontaneous abortion.

The HPRA said, since 2014, it had worked to disseminate information about Epilim through packaging, patient-alert cards, and front-line workers.

“The HPRA has communicated extensively with neurologists, obstetricians, paediatricians, psychiatrists, GPs, family planning clinics, specialist epilepsy nurses, pharmacists and HSE clinical leads,” it said, adding that it was awaiting the EMA’s further recommendations, which were expected in February.

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