Pregnancy and lactation advice: How does Australian Product Information compare with established information resources?

BACKGROUND: Product information is a popular medicines information resource; however, there is some evidence that its pregnancy and lactation information is overconservative, which can lead to inadequate treatment of pregnant and lactating women.

METHODS: A thorough analysis of pregnancy and lactation information within Australian Product Information and Consumer Medicines Information was performed. The statements within these resources were compared with established clinical resources: Australian Medicines Handbook, Therapeutic Guidelines, South Australian Perinatal Practice Guidelines, Organization of Teratology Information Specialists, LactMed, Motherisk and the Pregnancy and Breastfeeding Medicines Guide published by the Royal Women's Hospital Melbourne.

RESULTS: Product Information was found to be the most cautious resource, with 44.5% of pregnancy recommendations and 69% of lactation recommendations reviewed being more conservative than other resources.

CONCLUSION: Product Information is an imperfect and often overconservative reference for pregnant and lactating women. Health professionals are urged to review established clinical resources to inform decision making.