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Updated: May 24, 2025

Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
Published on: September 10, 2018
Drug safety in pregnancy
Debra Kennedy1,2,3, Ronald Batagol1,2,3
1Royal Hospital for Women, Sydney.
Abstract:
Drugs can affect the fetus in various ways, with the timing of exposure during pregnancy a key factor in determining both if and how a drug will impact a developing fetus. The exclusion of women of childbearing age from clinical trials, and the challenges in conducting large epidemiological studies, have resulted in a paucity of data on the fetal and maternal safety of drugs in pregnancy. In some patients, the benefits of drug treatment may outweigh the potential risks to the fetus. It is important for prescribers to assess and communicate the benefits and risks in the context of the individual patient. The Australian categorisation system for prescribing drugs in pregnancy was implemented to guide prescribers; however, it has shortcomings and lessons can be learned from the systems of other countries. Obstetric drug information services and other evidence-based resources are available to provide guidance to healthcare professionals and consumers on the use of drugs in pregnancy and breastfeeding.
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