Published: 12 April 2023
Safety Information
Alert communication
Topiramate use in pregnancy: further restrictions for safety
11 April 2023
Topiramate use in pregnant women has now been linked to an increased risk of neurodevelopmental disorders and birth defects in children whose mothers were taking topiramate during pregnancy. The increased risk of neurodevelopmental disorders, including autism spectrum disorder and intellectual disability, was identified in a large observational study.1
Janssen-Cilag, the sponsor for Topamax (topiramate) products, is updating the Topamax data sheet and issuing a Dear Healthcare Professional Letter with information relating to this safety update.
- Products affected
- Advice for consumers and caregivers
- Information for healthcare professionals
- Further information
- Useful links
- References
Products affected
Topiramate is a medicine used to treat epilepsy in adults and children aged 2 years and older. It is also indicated in adults for the prevention of migraines.2
| Product name | Sponsor |
|---|---|
| Topamax Film coated tablet | Janssen-Cilag (New Zealand) Ltd |
| Topamax Sprinkle capsule | Janssen-Cilag (New Zealand) Ltd |
| Topiramate Actavis film coated tablet | Teva Pharma (New Zealand) |
Advice for consumers and caregivers
- Do not stop taking topiramate without first talking to your doctor.
- Topiramate can harm the way an unborn baby grows and develops during pregnancy.
- Anyone who is able to get pregnant should use effective contraception while taking topiramate.
- Speak with your doctor if you are pregnant or planning to become pregnant whilst taking taking topiramate.
Information for healthcare professionals
- Topiramate should only be used to treat epilepsy in pregnancy if the potential benefit justifies the potential risk to the mother and fetus.
- Refer epileptic women taking topiramate who become or plan to become pregnant for specialist advice.
- The use of topiramate for migraine prophylaxis is contraindicated in pregnancy.
- Topiramate can cause fetal harm when administered to pregnant people.
- Congenital malformations and neurodevelopmental disorders have been reported in children following in utero topiramate exposure.
- Perform pregnancy testing before starting treatment. Women of childbearing potential should use a highly effective contraceptive method during treatment.
- Inform women of childbearing potential about the risks of fetal harm if they become pregnant.
- The Topamax data sheet contains new safety information about the risks of topiramate use in pregnant women.
Further information
The Topiramate data sheets already included information about the risk of congenital malformations. The risk of neurodevelopmental disorders was noted in an observational study based on data from five Nordic pregnancy registries (Denmark, Finland, Iceland, Norway, and Sweden). The registries captured information from over 24,000 children exposed to at least one antiepileptic medicine before birth. Of these children, 471 were exposed to topiramate alone.1
The authors reported a 2.77-fold increase in the risk of autism spectrum disorder and a 3.47-fold increase in the risk of intellectual disability in children with an epileptic mother taking topiramate during pregnancy compared to those with epileptic mothers not taking any antiepileptic treatment during pregnancy.1
Medsafe is alerting people to the findings of this study. Healthcare professionals must discuss the benefits and risks of treatment when prescribing or dispensing topiramate to women of childbearing potential.
Useful links
- Search for consumer medicine information (CMI) and data sheets
- Report an adverse reaction to a medicine
- Dear Healthcare Professional Letter
References
- Bjørk M-H, Zoega H, Leinonen MK, et al. 2022. Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability. JAMA Neurology 79(7): 672–81. DOI: 1001/jamaneurol.2022.1269 (accessed 24 March 2023).
- Janssen-Cilag New Zealand. 2023. Topamax Data Sheet 23 03 2023. URL: https://www.medsafe.govt.nz/profs/datasheet/t/topamaxtabcap.pdf (accessed 28 March 2023).
