Antiepileptic drugs: review of safety of use during pregnancy (MHRA, 7 January 2021)

Summary

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

Lamotrigine (Lamictal) and levetiracetam (Keppra) have been found to be safer than other antiepileptic drugs in pregnancy. The MHRA advises patients not to stop taking their current medicines without first discussing it with a healthcare professional.

Content

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

Valproate (Epilim) is already known to be seriously harmful if taken in pregnancy and should only be prescribed to a woman if a pregnancy prevention plan is in place. Importantly, two antiepileptic medicines in particular, lamotrigine (Lamictal) and levetiracetam (Keppra), have both been found to be safer than other antiepileptic drugs in pregnancy. The MHRA advises patients never to stop taking their current epilepsy medicines without first discussing it with a healthcare professional.

Dr Sarah Branch, Director of MHRA’s Vigilance and Risk Management of Medicines Division said:

• "Patient safety is our highest priority, and we are committed to making sure women are aware of the risks of taking certain epilepsy medicines during pregnancy, particularly valproate."
• "We have shared this important review with doctor and nurses so they can use it to inform discussions with their patients."
• "If a woman is planning to become pregnant, and is taking a medicine for epilepsy, even if this is some time in the future, it is very important that she should discuss with a healthcare professional the right treatment for her, taking into account the results of this review."
• "It is vitally important that women don’t ever stop taking any epilepsy medicine without discussing it first with a healthcare professional."