More epilepsy medicines linked to birth defects if taken during pregnancy

7 Jan 2021

Several epilepsy medicines carry risks when taken in pregnancy, a review, published today by the Medicines and Healthcare products Regulatory Agency (MHRA), has found.

The review, from the Commission on Human Medicines, looked at all the available safety data about 10 of the most commonly prescribed epilepsy medicines.

The medicine sodium valproate is known to cause an increased risk of birth defects and developmental problems in babies if taken during pregnancy. This prompted the review of the risks for other epilepsy medicines.

The review found that four out of the 10 epilepsy medicines increased the risk of a baby being born with a physical birth defect if taken during pregnancy. These were carbamazepine (brand name Tegretol), phenobarbital, phenytoin (brand name Epanutin) and topiramate (brand name Topamax).

Some of the medicines also increased the risk of children having learning or thinking difficulties later in life, or of babies being born smaller than average.

None of these medicines carried as high a risk if taken during pregnancy as sodium valproate, according to the review findings.

Lamotrigine (brand name Lamictal) and levetiracetam (brand name Keppra) were found to be safer in pregnancy than other epilepsy medicines.

A further 14 medicines were included in the review, but there was not enough evidence to reach a conclusion about their safety when used during pregnancy. More data are needed on these medicines to be able to comment on their safety during pregnancy.

Epilepsy Action stresses that it is important women do not stop or change how they take their epilepsy medicine without speaking to their doctor. Uncontrolled epilepsy can cause harm to both the mother and the unborn baby. The organisation advises anyone worried about their medicines to contact their epilepsy doctor or nurse.

Epilepsy Action is pushing for the swift circulation of these findings to healthcare professionals so they can help patients make informed choices. The organisation warns that mistakes made handling the safety information of sodium valproate must not be repeated.

Patricia was diagnosed with juvenile myoclonic epilepsy (JME) around 20 years old. She has been prescribed several epilepsy medicines to help control her seizures. One of her medicines was sodium valproate (Epilim).

Patricia has two children, Joseph, 20, and Amèlie, 11, who have both been affected by the medicine.

“I first learned about FACS (foetal anti-convulsant syndrome) and FVS (foetal valproate syndrome) in 2016, by which time Joseph was 15.

“I was devastated, particularly as we had not been warned about any of this, not when I was first prescribed them nor prior to becoming pregnant.

“It’s so frustrating to read women’s posts on forums, asking questions and posting photos of their babies, and knowing what I know. These women are being told they can take certain epilepsy medications during pregnancy and I find it so difficult to hear. It’s clear some of them still don’t know about the risks.

“I really hope that this review means that women can have conversations with their doctors and get all the detail they need to make their choices.”

Louise Cousins, director of External Affairs at Epilepsy Action, said: “It is imperative that this information is circulated to doctors and nurses widely and quickly. Past mistakes must not be repeated. We know that the consequences of women not knowing information such as this can be devastating. No woman or girl should be taking an anti-epileptic medication without them, or their family, being aware of the risks.

“Women with epilepsy often face difficult choices when they consider how to manage their condition through pregnancy. It is essential that they receive pre-conception counselling so they can work with their health professionals to make an informed choice.

“The review was unable to establish the risk in pregnancy of more epilepsy medications than those it was able to reach conclusions about. This is deeply concerning. We are urgently calling for more research looking into the risks of epilepsy medicines in pregnancy, including the risks of taking more than one medication at once – something many people with epilepsy have to do.

“We know that this new information may cause women with epilepsy and their families to feel worried. We urge anyone with concerns about medication they are taking, or have taken in the past, to speak to their doctor or nurse, or call the Epilepsy Action Helpline on 0808 800 5050.”

Epilepsy Action says this information could affect the choices of thousands of women with epilepsy, as well as raise concerns about the effects of these medicines if they've been taken during pregnancy in the past.

The organisation has written to Health Secretary Matt Hancock, calling for the reintroduction of pre-conception counselling for all women with epilepsy as an indicator in the Quality and Outcomes Framework (QOF). This will encourage GPs to talk to women about their options and the risks associated with these before becoming pregnant. Epilepsy Action has recently begun a new study with the University of Liverpool to design an ideal pathway for pre-conception counselling.

Epilepsy Action is also pushing for the recommendations of the First Do No Harm report, published following the Cumberlege review into three 'public health scandals', to be implemented in full. There is more information on epilepsy medicines and pregnancy on the Epilepsy Action website.

*NOTE (11 Jan 2021): An amend has been made to the information around lamotrigine and levetiracetam to clarify that they have been found to be 'safer' in pregnancy than other epilepsy medicines.*

 

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Government urged to issue apology over sodium valproate, Primodos and pelvic mesh ‘public health scandals’ by safety review

UPDATE (9 July 2020): Since the original story, the government has issued an apology to families affected by the public health scandals around the medical products sodium valproate, Primodos and pelvic mesh. You can read the full government response on the UK Parliament website.

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