Australia is grappling with a critical shortage of essential medications for pregnant women due to a combination of manufacturing and distribution challenges, experts warn. These shortages are exacerbated by the fact that the only medications deemed safe for pregnancy are outdated and less profitable, leading pharmaceutical companies to discontinue their distribution.
An editorial in the Medical Journal of Australia on Monday urged the government to establish a dedicated body for the registration, importation, and production of crucial pregnancy medications, independent of profit considerations. The shortage is particularly severe for high blood pressure medications. Labetalol has been scarce since late 2023, and both immediate-release nifedipine, used to prevent early labor, and oxprenolol have been withdrawn from the Australian market for commercial reasons.
Associate Professor Stefan Kane, director of maternity services at Melbourne’s Royal Women’s Hospital and lead author of the editorial, attributed the issue to the systematic exclusion of pregnant women from clinical drug trials. “Due to concerns about the impact of medications on pregnant women, exacerbated by past disasters like thalidomide, we now see a significant gap in new drug developments for this group,” Kane said. This exclusion has left practitioners reliant on old, off-patent medications that are more susceptible to supply issues.
The editorial contrasts the availability of over 50 drugs for high blood pressure in the general population with the mere six, all over 30 years old, available for pregnant women under Australian guidelines. This discrepancy limits access to newer medications that could offer fewer side effects and more stability in supply.
Australia’s sponsor-driven medication regulation system, which favors profitable new drugs over older, less lucrative ones, has exacerbated the problem. Since the pandemic, some manufacturers have ceased production of less profitable drugs, opting instead for more lucrative ventures. This “perfect storm” of factors is putting lives at risk, particularly in smaller regional and remote hospitals with limited access to critical medications.
Kane criticized the situation as indicative of broader systemic disadvantages faced by pregnant women. He emphasized that effective management of conditions like pre-eclampsia is crucial for maternal health. The editorial calls for alternative solutions to secure the supply of these medications, including supporting local production and ensuring safe inclusion of pregnant women in clinical trials.
Co-author Professor Amanda Henry of the George Institute for Global Health echoed the need to rethink the system to better balance the risks of including pregnant women in trials with the risks of their exclusion. Professor Barbara Mintzes from the University of Sydney highlighted the necessity for dedicated trials to test treatments commonly used off-label in pregnancy, underscoring that merely including a few pregnant women in existing trials would not address the current gaps.
