FSRH statement: highly effective contraception is crucial for women undergoing epilepsy treatment

We welcome the outcome of the safety review of epilepsy medicines in pregnancy by the Medicines and Healthcare products Regulatory Agency (MHRA).

The review has found that lamotrigine (Lamictal) and levetiracetam (Keppra), two antiepileptic medicines, are safer than other antiepileptic drugs in pregnancy.

Sodium valproate (Epilim) is already known to be seriously harmful to the developing baby if taken in pregnancy and should only be prescribed to a woman if a pregnancy prevention plan (PPP) is in place.

The report urges women to discuss treatment options with their doctor.

Dr Diana Mansour, Vice President of the Faculty of Sexual and Reproductive Healthcare (FSRH), said:

“We welcome the safety review of epilepsy medicines in pregnancy by the MHRA and support its call for women to discuss their treatment options if they are planning a future pregnancy.

“For those who do not wish to get pregnant, it is imperative they can access high-quality contraceptive counselling so they can choose an effective contraceptive method that suits them.

“Sodium valproate can cause a significant risk of birth defects, and up to 40% of children exposed to this drug in utero have persistent neurodevelopmental disorders. Women of reproductive age who are taking sodium valproate, or any other drugs with potential teratogenic effects, should always be advised to use highly effective contraception both during treatment and for the recommended timeframe after discontinuation of that teratogenic therapy to avoid unplanned pregnancies.

“The copper intrauterine device (IUD), the hormonal intrauterine system (IUS) and progestogen-only implant are highly-effective contraceptive methods, with a failure rate of less than 1% with typical use.

“Women should seek advice from their GP or epilepsy specialist, who will carry out a pregnancy risk assessment and provide advice to support their choice of effective contraception.”

ENDS

For further information please contact Camila Azevedo, FSRH External Affairs Manager, at cazevedo@fsrh.org or 02037945309.

Notes

• The safety review of epilepsy medicines in pregnancy by the Medicines and Healthcare products Regulatory Agency (MHRA) is available here.
• The 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.
• The review found that other epilepsy medicines may be associated with some increased risks of birth abnormalities or other effects on the baby. However, no epilepsy medicines reviewed are thought to have a risk greater than that of valproate.
• In 2018, the MHRA introduced the valproate pregnancy prevention programme (PPP). MHRA advises that healthcare professionals who seek to prescribe valproate to their female patients must make sure women are enrolled in the PPP.
• The most recent evidence-based FSRH guidance on drug interactions with hormonal contraception can be found here.

About FSRH
The Faculty of Sexual and Reproductive Healthcare (FSRH) is the largest UK multi-disciplinary professional membership organisation working at the heart of sexual and reproductive health (SRH), supporting healthcare professionals to deliver high quality care. It works with its 15,000 members, to shape sexual reproductive health for all. It produces evidence-based clinical guidance, standards, training, qualifications and research into SRH. It also delivers conferences and publishes the journal BMJ Sexual & Reproductive Health in partnership with the BMJ.