United States President Donald Trump claimed on Sept 22 (2025) that paracetamol (also termed acetaminophen) use during pregnancy was linked to autism in children.
He stated that the US Food and Drug Administration (FDA) would be “notifying physicians that the use of acetaminophen during pregnancy can be associated with a very increased risk of autism” and advised pregnant women to “fight like hell not to take it” and to “tough it out”.
The wide publicity given to Trump’s statement has led to anxiety and concerns among patients and doctors globally.
This column is intended to provide accurate, evidence-based information on paracetamol safety in pregnancy.
Necessary use
Paracetamol, which is sold under various trade or brand names in Malaysia and under the trade name Tylenol in the US, is commonly used in the management of fever and pain in pregnancy.
This is as such symptoms can pose risks to the foetus if left untreated.
Untreated fever during early pregnancy is associated with an increased risk of miscarriage, neural tube defects, cleft palate and cardiac (heart) anomalies, and in the later stages of pregnancy, with foetal growth restriction and premature birth.
Untreated pain can lead to maternal anxiety, high blood pressure and depression.
The alternatives to paracetamol are very limited.
Non-steroidal anti-inflammatory drugs (NSAIDS) like ibuprofen, naproxen, diclofenac and celecoxib are not recommended because their use at about 20 weeks or later in pregnancy may cause foetal kidney dysfunction.
This, in turn, can lead to low levels of amniotic fluid with its attendant complications, and premature closure of the foetal ductus arteriosus.
An exception is low dose aspirin prescribed for prevention of high blood pressure.
Related research
A comprehensive and methodologically-sound study on this issue was a Swedish population-based study published in April 2024 in the Journal of American Medical Association.
The study involved 2.48 million children born between 1995 to 2019, who were followed up to Dec 31, 2021.
It employed sibling control analysis (a methodology that controls for shared genetic and environmental factors within families, which is the gold standard that addresses confounding in observational research).
The study found that when familial confounding was properly controlled through sibling analysis, there was no evidence of increased risk for autism, attention-deficit/hyperactivity disorder (ADHD) or intellectual disability, associated with paracetamol use during pregnancy.
The authors concluded: “Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD or intellectual disability in sibling control analysis.
“This suggests that associations observed in other models may have been attributable to familial confounding.”
Among the references quoted by the Trump administration to support his claim was a review published in the journal Environmental Health in August (2025).
Although the review included 46 studies, it has been criticised extensively as some of the studies included were of questionable quality because:
- They relied on self-reported acetaminophen use, with considerable potential for recall bias, or biased reporting of events or experiences due to inaccurate or incomplete recounting
- They included limited or no information on dosage and duration of the acetaminophen exposure
- They featured different kinds of assessment of neurodevelopmental milestones over time instead of using a single standardised, uniform assessment method, and
- They lacked controls for confounding factors.
The review was also compromised by conflict of interest as the study’s corresponding author had previously received payment to testify against the then manufacturer of Tylenol in a class action lawsuit linking the drug to autism.
His expert testimony was rejected by the court as scientifically-unfounded.
In fact, the authors in the analysis actually concluded: “We recommend judicious acetaminophen use – lowest effective dose, shortest duration – under medical guidance, tailored to individual risk-benefit assessments, rather than a broad limitation.”
Global pushback
The American College of Obstetricians and Gynaecologists (ACOG), in an advisory issued after Trump’s statement stated: “ACOG reaffirms that acetaminophen remains the analgesic and antipyretic of choice during pregnancy.
“Judicious use at the lowest effective dose for the shortest necessary duration, in consultation with an obstetrician-gynaecologist or other obstetric care professional, remains consistent with best practice.
“The current weight of evidence does not support a causal link between prenatal acetaminophen use and neurodevelopmental disorders.
“At this time, no change in clinical practice is warranted based on new publications and ACOG’s recommendations for the use of acetaminophen for specific indications remain current.”
Britain’s Royal College of Obstetricians and Gynaecologists (RCOG) stated on Sept 23 (2025) that: “The Medicines and Healthcare products Regulatory Agency (MHRA), the World Health Organization (WHO) and the European Medicines Agency have all published clear statements on the safety of paracetamol use in pregnancy, stating that there is no confirmed link between taking paracetamol during pregnancy and autism in children.
“Paracetamol remains the recommended pain relief option for pregnant women when clinically needed and used as directed.”
The Royal Australasian College of Obstetricians and Gynaecologists (RANZCOG) stated on Sept 23 (2025) that: “The Trump administration has issued highly controversial claims regarding the causes of autism and ADHD, asserting that paracetamol (also known as acetaminophen) use during pregnancy increases the risk of children being diagnosed as neurodivergent.
“The RANZCOG joins leading clinicians and scientists worldwide in vehemently rejecting these claims.
“Robust scientific evidence shows no link between paracetamol use in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting the administration’s statement."
The International Federation of Gynaecology and Obstetrics (FIGO) stated: “Obstetric practice should be based on evidence-based medicine and careful evaluation of research methodology.
“Recent statements questioning paracetamol safety go against established scientific findings and may harm maternal and foetal health by discouraging use of this medication based on methodologically flawed research.”
The WHO stated on Sept 24 (2025) that: “Extensive research has been undertaken over the past decade, including large-scale studies, looking into links between acetaminophen use during pregnancy and autism.
“At this time, no consistent association has been established.”
Malaysia’s Health director-general stated on Sept 25 (2025) that paracetamol and childhood vaccinations are not causes of autism.
He added: “Based on current medical practice and the latest clinical guidelines, paracetamol is still considered one of the safest options if taken at the lowest effective dose and for the shortest possible duration.”
Various autism organisations in the US have denounced Trump’s statement.
Thinking Person’s Guide to Autism senior editor Shannon Rosa stated that while different autism groups disagree about a number of things, many said that the White House’s latest claim was nonsensical.
“It feels to me like we’ve regressed so horribly and intentionally by the administration, because as they’ve demonstrated constantly, they have no interest in actual science.
“They have no interest in research; they have no interest in the welfare of autistic people and their families.
“They are only interested in whatever people whispering into their ears have told them they should do,” she said.
Talk to your doc
It is patently obvious that Trump and those around him do not know the difference between association and causation.
Association means a relationship between two or more variables.
They may be coincidental, effected by other unknown variable(s), and/or with further research, proven false or causative.
On the other hand, causation means that one variable caused a direct effect on another variable.
Any claim of causation has to be reproducible to be proven as fact.
All women and their healthcare providers should be reassured by the statements from international professional organisations and regulators about paracetamol use in pregnancy.
All medicines prescribed in pregnancy follow a risk-benefit assessment of necessity, safety profile and goal, which is to use the safest possible medicine at the lowest effective dose for the shortest duration.
The advice to patients is:
- Always consult your healthcare provider – never start or stop taking medicines without first discussing with your doctor, midwife or pharmacist.
- Inform all healthcare providers if you are pregnant or trying to get pregnant.
- Use medicines only when necessary – this is particularly so as paracetamol is a common cause of poisoning in Malaysia.
- Do not forgo prescribed medicines as an untreated condition may harm both mother and foetus.
- If there are concerns or questions about paracetamol use, discuss with your doctor, midwife or pharmacist.
Dr Milton Lum is a past president of the Federation of Private Medical Practitioners Associations and the Malaysian Medical Association. For more information, email starhealth@thestar.com.my. The views expressed do not represent that of organisations that the writer is associated with. The information provided is for educational and communication purposes only, and it should not be construed as personal medical advice. Information published in this article is not intended to replace, supplant or augment a consultation with a health professional regarding the reader’s own medical care. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.
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