Availability and Communication of Risk Management Strategies for Pregnancy Category X Medicines across Australian Medicine Information Sources.

Authors

Helen Mayer, Jacquelina Stasinopoulos, Bronni Simpson, Jessica Gehlert, Luke E Grzeskowiak

Published in

Drug safety. Jul 01, 2026. Epub Jul 01, 2026.

Abstract

Category X medicines are those which have such a high risk of causing foetal harm that they are contraindicated in pregnancy. When used in reproductive age women, risk management strategies are warranted to reduce unintended pregnancy exposure.
To identify documentation of pregnancy risk management strategies for Category X medicines across Australian medicine information sources.
The TGA Prescribing Medicines in Pregnancy Database (PMPD) was searched to identify Category X medicines licensed for indications relevant to reproductive age women. For each Category X medicine included in this evaluation, regulatory documents (Product Information [PI] and Consumer Medicine Information [CMI]) and corresponding monographs/chapters in clinical resources (Australian Medicines Handbook [AMH] and Therapeutic Guidelines [TG]) were reviewed for boxed warnings relating to pregnancy risks, pregnancy testing and contraception recommendations, and formal pregnancy prevention programs.
Thirty-nine Category X medicines were retrieved through the TGA PMPD, 19 of which met the inclusion criteria. Boxed warnings documenting pregnancy risks were present for 47% (9/19) of medicines. Pregnancy testing and contraception recommendations appeared in most PIs and CMIs (89%, 17/19), as well as in 15 of 17 (88%) medicines listed in the AMH, but were only present for one of 12 (8%) medicines listed in the TG. Structured pregnancy prevention programs exist for only 16% (3/19) of medicines.
Pregnancy risk management strategies for Category X medicines are inconsistently employed across Australian medicine information sources. Improving the quality and consistency of pregnancy risk management strategies is necessary to avoid harms from inadvertent exposure during pregnancy.

PMID:
42384309
Bibliographic data and abstract were imported from PubMed on 01 Jul 2026.

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