From 1 April eight anti-seizure medicines will be subject to a cautionary advisory label, warning of the risks associated with taking them during pregnancy. This is the first time a pharmacist-added pregnancy cautionary advisory label has been added to any medicine in New Zealand.
The cautionary advisory label is similar to the pregnancy warning labels found on other products that have the potential to cause harm to unborn babies. It is the result of the Ministry of Health’s ongoing work with Foetal Anti-Convulsant Syndrome New Zealand (FACSNZ) to raise awareness of, and prevent, Foetal Anti-Convulsant Syndrome (FACS).
Anti-seizure medicines are used for managing seizure disorders, such as epilepsy, as well as for migraines, supporting mood stabilisation, and managing nerve pain. Taking them during pregnancy can result in FACS which may include physical malformation in babies, including spina bifida, heart defects, or cleft palate. Babies with FACS can also have developmental and learning difficulties, including autism and ADHD.
Cautionary advisory labels provide clear, visible warnings and are a daily reminder of the risks associated with these medicines. The cautionary advisory label, applied to a medicine by a pharmacist, will help to reinforce the information patients receive about their medicines from their doctor.
Audrey Sonerson Director-General of Health says, “For many people, their local pharmacy is their most frequent point of contact with the health system.
“Pharmacists are in a key position to pass on and reinforce important information about the medicines they dispense. They can also spot opportunities for early conversations about medicine safety in pregnancy, including advising people to see their prescriber for further information about the medicines they take.”
The Ministry estimates that approximately 48,000 people are currently taking the medicines which are now subject to a cautionary advisory label.
Denise Astill Executive Officer of FACSNZ says, “This cautionary advisory label could and should spark regular conversations about the medicines people are taking and the risks associated with them. These conversations could help to prevent FACS.”
This work is part of a coordinated approach between the Ministry of Health, FACSNZ, the Pharmacy Guild, Pharmaceutical Society, and the wider pharmacy sector to improve patient safety and prevent Foetal Anti-Convulsant Syndrome.
Further information
Example of the new cautionary advisory label
This label will be applied to the following anti-seizure medicines:
- carbamazepine
- ethosuximide
- oxcarbazepine
- phenobarbitone
- phenytoin
- primidone
- sodium valproate
- topiramate.
These anti-seizure medicines carry the greatest risk of causing foetal anticonvulsant syndrome (FACS). See Medsafe. Epilepsy medicines and pregnancy. Ministry of Health, January 2025 (PDF, 312 KB).
To understand more about medicine labelling see the Medsafe website.
Find out more about Foetal Anti-Convulsant Syndrome New Zealand.
For further information about Foetal Anti-Convulsant Syndrome see Healthify: Foetal anticonvulsant syndrome.
