Publication of CHM advice on antiepileptic drugs in pregnancy

Dear Colleagues,

In the context of the known harms of valproate in pregnancy, the MHRA and Commission on Human Medicines (CHM) have conducted a review of the safety of the use of other antiepileptic drugs during pregnancy - click here.

According to the report, levetiracetam and lamotrigine appear to be the safest options to use during pregnancy in terms of risks for the child. Increased risks were noted with several of the other commonly used antiepileptic drugs such as carbamazepine, phenobarbital, phenytoin, topiramate and possibly zonisamide. There was too little information available for many of the newer or less commonly used drugs such as pregabalin, gabapentin and oxcarbazepine to draw firm conclusions. The full report, with much more detailed information, is attached with this email and we would recommend that you at least look at the summary and recommended actions even if you do not read the full report. It is important always to consider the whole picture, including the wishes and safety of the mother, and treatment of her epilepsy. Any discussion should be informed, and include both the benefits and risks of alternative courses of action.

One of the recommendations in the report is for regular serum levels of lamotrigine to be measured during pregnancy. This is currently not advised by SIGN and the EMPiRE study from 2018 did not find any difference in outcome associated with regular monitoring, but suggested individual prediction models to identify women who would benefit from this.

Whilst valproate was not the focus on the report, we should continue to follow the MHRA guidelines regarding prescription in women of childbearing potential. Additional guidance is available on the ABN website (link). We would encourage you and your teams to carry out the ABN audit (link). The deadline for submission of data is 5^th March 2021.

A lot of work has gone into this review and the information provided should be very useful to clinicians and enable us to provide our patients with more granular information on their individual risks to facilitate decision making when preparing for as safe a pregnancy as is possible.

Sanjay Sisodiya  Sofia Eriksson
ABN Epilepsy Chair ABN Council Member