A safety review of antiepileptic drugs by the MHRA has concluded that lamotrigine (Lamictal) and levetiracetam (Keppra) are safer than other antiepileptic drugs for women who are pregnant.
Prescribers are being advised that at initiation and as part of the recommended annual review for female patients with epilepsy, specialists should discuss the risks of taking antiepileptic drugs during pregnancy.
Women who are planning to become pregnant should be urgently referred for specialist advice on their antiepileptic treatment, says the MHRA.
All women using antiepileptic drugs who are planning to become pregnant should be offered 5mg per day of folic acid before any possibility of pregnancy. For lamotrigine, levetiracetam it is recommended to use monotherapy whenever possible, and use the lowest effective dose.
The safety review looked at the risk of major birth defects and concerns with the child’s mental development for key antiepileptic drugs. Valproate (Epilim) is already known to be seriously harmful if taken in pregnancy and should only be prescribed if a pregnancy prevention plan is in place.
Studies involving more than 12,000 pregnancies exposed to lamotrigine monotherapy consistently showed that at maintenance doses it does not increase the risk of major congenital malformations. Likewise, studies involving more than 1,800 pregnancies exposed to levetiracetam do not suggest an increased risk.
For both lamotrigine and levetiracetam, the data on neurodevelopmental outcomes are more limited, although the available studies do not suggest an increased risk with either drug.
However, data show an increased risk of major congenital malformations with carbamazepine, phenobarbital, phenytoin, and topiramate if used during pregnancy.
There is a possibility of adverse effects on neurodevelopment of children exposed in utero to phenobarbital and phenytoin, and an increased risk of foetal growth restriction associated with phenobarbital, topiramate, and zonisamide use during pregnancy.
NICE has welcomed the review. Paul Chrisp, director of the Centre for Guidelines at NICE, said: “It’s important that everyone affected by these latest changes is made aware of them as soon as possible.
“We’re taking steps to review our guidelines where these medicines are recommended, including in the management of bipolar disorder, depression in adults, and antenatal and postnatal mental health to reflect this important advice.”
NICE guidelines on the diagnosis and management of epilepsies is currently being updated as part of its normal review cycle.