MHRA Publishes Safety Review of Epilepsy Medicines in Pregnancy

Priscilla Lynch 

January 12, 2021

Women receiving treatment for epilepsy are being urged to discuss with a health care professional the right treatment for them if they anticipate becoming pregnant, following a safety review by the Medicines and Healthcare products Regulatory Agency (MHRA).

The review on the use of epilepsy medicines in pregnancy was carried out following earlier reviews of the antiepileptic medicine valproate, which is known to be teratogenic.

The review examined available safety data for risks of major birth defects or abnormalities and concerns with child development, including learning and thinking abilities, for other key antiepileptic drugs. It found that a number of these may also be associated with some increased risks in pregnancy.

Lamotrigine (Lamictal) and levetiracetam (Keppra) were both found to be safer than other anti-epileptic drugs in pregnancy.

The MHRA is asking clinicians to use the review’s findings to discuss the potential risks to the baby associated with epilepsy medicines and untreated epilepsy during pregnancy, and to review patients' treatment according to their clinical condition and circumstances.

The MHRA has produced a safety information leaflet to help with this discussion, and advises patients never to stop taking their current epilepsy medicines without first discussing it with a health care professional.

Paul Chrisp, Director of the Centre for Guidelines at NICE, said: "NICE welcomes this move from MHRA to ensure women are fully aware of the risks of taking certain epilepsy medicines during pregnancy. We’ve already made changes to our guidelines to reflect MHRA’s earlier advice about the use of sodium valproate."

"It’s important that everyone affected by these latest changes is made aware of them as soon as possible. We’re therefore taking steps to review our guidelines where these medicines are recommended, including the assessment and management of bipolar disorder, depression in adults, and antenatal and postnatal mental health to reflect this important advice."

This article originally appeared on Univadis, part of the Medscape Professional Network.

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