Eight anti-seizure medications will now carry a warning label highlighting the risks of use during pregnancy. This marks the first time in New Zealand that pharmacists have been required to add a pregnancy-specific cautionary advisory label to any medication.
The advisory label mirrors pregnancy warnings used on other products known to pose risks to unborn babies. It follows ongoing collaboration between the Ministry of Health and Foetal Anti-Convulsant New Zealand (FACSNZ) to boost awareness of, and help prevent, Foetal Anti-Convulsant Syndrome (FACS).
Anti-seizure medications are used to treat seizure disorders like epilepsy, and are also prescribed for migraines, mood stabilisation, and nerve pain management.
Using these medicines during pregnancy can lead to Foetal Anti-Convulsant Syndrome (FACS), which may cause physical abnormalities such as spina bifida, heart defects, or cleft palate.
Affected children may also experience developmental and learning challenges, including autism and ADHD.
Cautionary advisory labels offer clear, highly visible warnings and serve as a daily reminder of the risks linked to these medicines. Applied by pharmacists, the label also reinforces the guidance patients receive from their doctors about safe use.
The new advisory label will be applied to medicines, including carbamazepine, ethosuximide, oxcarbazepine, phenobarbitone, phenytoin, primidone, sodium valproate, and topiramate.
“For many people, their local pharmacy is their most frequent point of contact with the health system,” Audrey Sonerson, Director-General of Health, said.
“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.”
For FACSNZ executive officer Denise Astill, the cautionary 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.”