Australia weighs paracetamol safety as Trump claims link to autism

Australian health officials moved to reassure pregnant women on Tuesday that paracetamol remains the recommended option for pain relief, even as U.S. President Donald Trump pressed for warnings about the drug’s use during pregnancy and its possible link to autism. The Trump administration has suggested the FDA would direct physicians to tell pregnant patients to avoid paracetamol except in cases of extreme fever, a signal that prompted a sharp response from Australian health policymakers and medical experts about relying on robust evidence rather than unproven claims.

Trump’s remarks during a Monday press conference asserted that the active ingredient in Tylenol, paracetamol, could hinder fetal brain development and might cause autism if taken by pregnant women. He urged parents not to administer the drug to their children either and insisted that the drug be used only when highly necessary and under medical supervision. While the administration argues that some studies point to a possible risk, most research to date has not demonstrated a causal link between paracetamol use in pregnancy and autism. Global health bodies, including those in Australia, continue to support paracetamol as a safe option for pregnant women when needed for pain or fever.

Health policy expert and former Australian Deputy Chief Medical Officer Dr Nick Coatsworth pushed back on the strongest of Trump’s assertions, stressing that the association between paracetamol use in pregnancy and brain development is nuanced. “When [Trump] says there is a very strong link, I think that’s wrong. I don’t think that’s supported by the evidence. I think that paracetamol is safe in pregnancy,” he told local media, while noting that the body of research requires careful interpretation.

Coatsworth emphasized that, for medications used by pregnant women, continuous study is essential. “As a doctor, if I saw a pregnant woman in pain today, I would be advising them to have paracetamol,” he said. He also cautioned against self-medicating with high doses, urging patients to seek medical advice for ongoing pain in pregnancy and to avoid taking large quantities without professional input. He framed the issue as part of a broader scientific process, where observational birth cohort studies can flag potential patterns but are not definitive for causation.

The Australian Therapeutic Goods Administration (TGA) reinforced the stance that paracetamol remains safe for use during pregnancy and remains classified as pregnancy category A, meaning it is considered appropriate when used as directed. Despite the ministerial call for urgent advice on Panadol, TGA officials reiterated their position that there is no conclusive evidence linking prenatal paracetamol exposure to autism and that the drug should continue to be used to relieve pain in pregnancy under medical supervision if needed.

AMA president Danielle McMullen echoed the lack of a proven causal link, telling ABC RN Breakfast that large studies have not shown a connection between paracetamol use in pregnancy and autism. “There have been some studies showing what we call an association between paracetamol use and autism in children, but there’s also been really large studies showing that there’s no association,” she said. “Association does not mean cause.” The AMA stance aligns with international guidance that paracetamol remains the analgesic of choice for pregnant women when pain relief is necessary.

Health Minister Mark Butler’s call for urgent advice drew a mixed reception among clinicians. Some criticized the move as alarmist, while others argued it underscored a commitment to scrutinize even widely used medications as more data become available. Dr. Coatsworth described Butler’s approach as akin to “calling the fire department for the toast burning,” a metaphor he used to express concern that urgent action could unnecessarily undermine confidence in safe medical practices. He stressed that the best course for Australian women remains guided by medical assessment and established safety profiles of commonly used pain relievers.

Beyond the paracetamol debate, Trump’s broader vaccination comments drew scrutiny from Australian health experts. Trump has criticized the MMR vaccine, urging Americans to break it into separate shots, while calling himself a proponent of vaccines. Coatsworth said such messaging threatens herd immunity, noting that even small changes in vaccination behavior can affect public health outcomes. He warned that political rhetoric about vaccines can erode public trust and hinder ongoing research into vaccine safety and effectiveness.

The Trump administration’s remarks come as health officials wrestle with rising autism prevalence in the United States. They cited estimates suggesting a steep increase from earlier decades, though experts have attributed much of the rise to broader diagnostic criteria and improved detection rather than a single causative factor. RFK Jr., who has promoted theories about environmental toxins, maternal obesity, and parental age, has been a visible advocate of broader debates about autism risk factors. Medical researchers and public health authorities have consistently cautioned against drawing causal conclusions from preliminary associations.

Paracetamol manufacturers have pushed back against the claim that the drug causes autism, arguing that the medicine remains one of the safest options for pain and fever relief during pregnancy when used appropriately. The broader risk-benefit calculus for pain management in pregnancy remains a focus for clinicians, who stress consulting a healthcare professional for persistent or severe pain.

In Australia, officials are urging a careful, evidence-based approach. While the minister’s office weighs urgent guidance, health authorities insist thatPanadol should continue to be used for pregnancy-related pain when medically indicated, with supervision from a clinician if pain persists. The balance, they say, is to ensure pregnant women receive effective relief while maintaining scrutiny over evolving research and regulatory guidance. As investigations and studies continue, Australian health authorities reiterate that current evidence supports paracetamol as a safe option during pregnancy when used as directed, and that clinicians should tailor advice to the individual patient’s condition and medical history.

The unfolding discussion highlights the tension between rapid political messaging and careful, data-driven medical guidance. For now, Australian doctors and regulators are coordinating to maintain public confidence in safe treatment options during pregnancy while continuing to monitor emerging research on analgesics and neurodevelopmental outcomes. The takeaway for expectant parents remains clear: if pain is present during pregnancy, seek medical advice, and use paracetamol only as directed and under professional supervision. Paracetamol, in this view, continues to be the recommended option when clinically appropriate, with ongoing oversight from the TGA and healthcare professionals as evidence evolves.