Warnings from Donald Trump that acetaminophen (popular brand name Tylenol), also known as paracetamol (popular brand name Panadol) has a causative link to autism when taken by pregnant women are unsupported and rejected by health authorities world wide.
Absurdly, his ramblings were a unilateral seizure of what was apparently a planned nuanced announcement, prepared by his own so-called health administration. They intended a caution on Tylenol, a supposed treatment for autism and to reveal $50 million for autism research.
Using his feelings and purported anecdotes, Trump urged pregnant women to “fight like hell” against paracetamol. He reasoned with a bizarre risk-benefit myth that not taking the drug meant only good things would happen, opposed to the risk of bad things, if women took the drug. Yet the reality is that paracetamol/acetaminophen is necessary to combat fevers women may experience during pregnancy and that failure to treat fever can cause neurodevelopmental disorders for the unborn child. These include autism, ADHD or developmental delay. Another identified risk is miscarriage.
Trump also used vague anecdotes to link the vaccine schedule to childhood death and harm. There is no evidence for either Trump’s tale of vaccines killing the child of an employee, and no scientific evidence to justify the changing of vaccination schedules. Trump argued the Hepatitis B vaccine should be held off until 12 years. Yet the primary source of exposure for infants and children is maternal, not sexual activity as claimed by Trump. He further suggested spacing out Measles, Mumps and Rubella vaccines as well as other combined vaccines. The apparent logic is that children are given too many antigens at once.
In fact, children receive fewer antigens today to combat a greater range of disease. Thirty years ago 30,000 antigens were required to encourage immunity against 8 diseases. Today’s US vaccine schedule uses 305 antigens to tackle 14 diseases. And active children take on 2,000 – 6,000 antigens daily through eating, playing and even breathing.
Pregnant women should fight like hell to ignore Donald Trump’s monumental woo.
Therapeutic Goods Administration Statement – 23 September 2025
- Australia’s Chief Medical Officer and the TGA join with other global medicines regulators, leading clinicians and scientists worldwide in rejecting claims regarding the use of paracetamol in pregnancy, and the subsequent risk of development of ADHD or autism in children.
- Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims.
- Paracetamol remains the recommended treatment option for pain or fever in pregnant women when used as directed. Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment. Pregnant women should speak to their healthcare professionals if they have questions about any medication during pregnancy.
- Paracetamol remains pregnancy category A in Australia, meaning that it is considered safe for use in pregnancy when used according to directions in TGA-approved Product Information (PI) and Consumer Medicines Information (CMI) documents.
- This means that a medicine has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed. As with the use of any medicine during pregnancy, people who are pregnant should seek medical advice tailored to their specific circumstances before taking paracetamol.
- The TGA is responsible for ensuring the safety, quality and efficacy of medicines on the Australian Register of Therapeutic Goods (ARTG), with safety in pregnancy a key consideration for all products on the ARTG.
The TGA undertakes evaluation of clinical, scientific and toxicological data prior to registration of a medicine, and this information is summarised in TGA-approved PI and CMI documents, targeted at healthcare professionals and consumers respectively, to help support safe use of a medicine in the community. These documents include information relating to use of a medicine in pregnancy.
- The TGA is aware of announcements by the US Administration that use of paracetamol in pregnancy may be associated with an increased risk of autism and ADHD in children, though a causal association has not been established.
- TGA advice on medicines in pregnancy is based on rigorous assessment of the best available scientific evidence. Any new evidence that could affect our recommendations would be carefully evaluated by our independent scientific experts.
- Whilst there are published articles suggesting an association between maternal paracetamol use and childhood autism, they had methodological limitations. More recent and robust studies have refuted these claims, supporting the weight of other scientific evidence that does not support a causal link between paracetamol and autism or ADHD.
- The TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol. This includes detailed analysis of adverse event reports made by medicine consumers, clinicians and pharmaceutical companies, review of published medical literature, and close liaison with international medicines regulators. If a safety issue is confirmed prompt regulatory action is taken to mitigate risks.
- International peer regulators including the Medicine and Healthcare products Regulatory Agency (MHRA) in the United Kingdom have reiterated that paracetamol should continue to be used in line with product information documents. Following evaluation in 2019 the European Medicines Agency (EMA) found that scientific evidence regarding effects of paracetamol on childhood neurodevelopment was inconclusive.
- People who have concerns and are pregnant, or considering pregnancy, are advised to consult their healthcare professionals in the first instance to discuss this issue. [Source ©️ TGA]
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