The Women’s Pregnancy Recommendations

Safe to use

Medicines where there is extensive human experience confirming that they do not increase the frequency of malformations or other direct or indirect harmful effects to the fetus.

Considered safe to use

The limited information available indicates that these medicines do not increase the frequency of malformations but some observations may be required.

Monitoring required

The limited information available indicates that these medicines do not increase the frequency of malformations, however monitoring is required. This may include blood tests for therapeutic drug levels, liver function or thyroid function. Monitoring of maternal and fetal wellbeing as well as any potential adverse effects in the newborn may be required.

Consider alternative

For medicines that have no human pregnancy experience or very few cases of pregnancy exposure, an alternative medicine should be considered. The use of these medicines may have been associated with developmental toxicity such as growth restriction, structural defects or death. The medicine should not be used in pregnancy, but when it is the only medicine available, the benefits versus risks of use need to be discussed with the pregnant woman.

Contraindicated

Medicines that have teratogenic, or irreversible undesirable effects, or are associated with developmental toxicity such as growth restriction, structural defects, functional or behavioural deficits, or death. These medicines are to be avoided throughout pregnancy. Consultation with a specialist is highly recommended. Women who have been exposed to these agents may require further counselling.

Last Updated: 3 March 2015

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Summarises key findings and provides detailed, practical recommendations on the use of medicines during pregnancy and breastfeeding to support the clinical decision making process

All available information is fully referenced; peer reviewed and is constantly updated.

Downloadable medicine fact sheets for patients

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Practical recommendations

The Therapeutic Goods Adminsitration (TGA) pregnancy categories and manufacturer’s product information are sometimes difficult to interpret. The Women’s PBMG has developed a series of practical recommendations for medicines used during pregnancy and breastfeeding.