Paracetamol in Pregnancy Not Linked to Autism, SA Medical Societies Say

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South African medical societies have strongly rejected recent claims that taking paracetamol during pregnancy causes autism in children, placing themselves firmly in line with international health authorities who say the available science does not support a causal link.

Background​

The controversy flared after high-profile public statements asserting a link between prenatal paracetamol (acetaminophen) exposure and autism spectrum disorder (ASD). Those claims prompted a rapid response from national and international medical bodies, which reviewed the evidence and issued reassurances about current clinical practice. The World Health Organization (WHO) publicly stated that there is no conclusive scientific evidence that taking acetaminophen during pregnancy causes autism, and urged pregnant women to follow professional medical advice rather than sensationalised headlines.
In South Africa, the Alkemi Collective—a grouping representing the South African Society of Obstetricians and Gynaecologists (SASOG), the Society of Obstetric Medicine of South Africa (SOOMSA), and the South African Society for Ultrasound in Obstetrics and Gynaecology (SASUOG)—issued a joint statement after reviewing the literature and concluded there is no reliable evidence that paracetamol at recommended therapeutic doses causes ASD. These societies emphasised that untreated fever and significant pain in pregnancy carry demonstrable risks to both mother and fetus, and that paracetamol remains the safest and most effective first-line option when used as directed.

What the medical societies actually said​

  • The Alkemi Collective reported that large, high-quality studies—including sibling-control analyses—do not support a causal relationship between paracetamol use in pregnancy and autism.
  • SOOMSA’s president highlighted that when stronger study designs that control for familial and genetic confounding are applied, apparent associations largely disappear.
  • The societies reiterated recommended dosing guidance (typically 500–1000 mg, up to four times daily, not exceeding 4 g per 24 hours), and advised pregnant women to consult their clinicians if they have concerns.
These statements reflect consensus clinical guidance from regulators and professional bodies around the world: paracetamol should be used judiciously in pregnancy, at the lowest effective dose for the shortest necessary duration, but not avoided when clinically indicated.

The evidence landscape: why confusion persists​

Observational signals, not proof of causation​

Over the past decade researchers have published a number of observational epidemiological studies that reported small associations between maternal paracetamol use and neurodevelopmental outcomes, including ADHD and autism. Those early findings generated legitimate scientific interest but do not establish causation. Observational studies are particularly vulnerable to confounding factors: genetic predisposition, maternal illness that prompted analgesic use (for example infection or fever), socioeconomic variables, and exposure misclassification from self-reported medication histories. More robust analytic approaches—such as sibling-comparison studies that compare siblings with discordant exposures—are less susceptible to these shared-family confounders and generally have not supported a causal link.

Large population studies and sibling analyses​

High-quality population-level analyses have been central to the rebuttal. For example, recent sibling-controlled studies and multi-million-child cohort analyses have shown that when familial factors are accounted for, the apparent association between prenatal paracetamol exposure and ASD is attenuated or disappears. South African societies explicitly pointed to these stronger study designs when they concluded that the preponderance of evidence does not support changing clinical practice.

Regulatory reviews and systematic assessments​

Regulatory agencies and academic groups have repeatedly reviewed the evidence and concluded it is inconsistent and insufficient to support causation. The European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and other national regulators have reiterated that existing guidance on paracetamol use in pregnancy remains valid: use as directed, seek clinical advice if in doubt, and avoid unnecessary prolonged or high-dose use. The WHO’s statement in late September echoed that assessment at a global level.

Clinical context: risks of untreated fever and pain in pregnancy​

Any discussion about medicines in pregnancy must weigh both the risks of exposure and the risks of not treating a medical problem. Fever in pregnancy has known associations with adverse outcomes, including congenital anomalies and miscarriage when severe and untreated; similarly, unrelieved severe pain can affect maternal mental health, sleep, nutrition, and pregnancy care. For these reasons obstetric and maternal-fetal medicine societies emphasise that paracetamol, when used appropriately, remains the safest and most effective option to manage fever and mild-to-moderate pain in pregnancy. The South African statement explicitly made this point, urging clinicians and pregnant people not to withhold appropriate care based on unproven claims.

Why high-profile public claims matter — and why they’re dangerous​

High-visibility assertions from political leaders or celebrities on matters of health can trigger immediate behaviour change in the public, even when the assertions are not supported by robust science. This matters for several reasons:
  • Public fear and avoidant behaviour. Pregnant people who are worried may avoid necessary treatment for fever or pain, potentially increasing risk to mother and fetus. The South African societies and WHO both emphasised this immediate harm.
  • Erosion of trust in science and clinicians. Repeated misinformation can undermine confidence in public-health guidance and drive people toward unproven alternatives. International bodies noted that the debate risked diverting attention from interventions that are evidence-based.
  • Stigmatization of affected families. Framing autism as a straightforward consequence of parental behaviour or simple exposures is reductive and stigmatizing; it ignores the complex, multifactorial nature of neurodevelopmental disorders and can shift blame onto mothers. Patient and disability advocates have stressed that such rhetoric causes real social harm.

What clinicians should tell patients (practical guidance)​

  • Reassure patients that current evidence does not show a causal link between paracetamol in pregnancy and autism. Highlight that major regulators and WHO recommend continuing to use paracetamol when clinically indicated.
  • Advise use at the lowest effective dose for the shortest necessary time. Follow product labelling and local clinical guidance (typical dosing up to 1,000 mg per dose, not exceeding 4 g per day unless supervised).
  • Emphasise the risks of untreated fever and significant pain. Explain that uncontrolled fever and serious infections carry known pregnancy risks that often outweigh theoretical medication concerns.
  • If patients are anxious, offer tailored review. Discuss individual history, alternative options, and referral to obstetric medicine specialists if needed. Shared decision-making is critical.

The science still evolves: where more research is useful​

Medical science rarely produces absolute answers overnight. While the current consensus is that paracetamol at therapeutic doses is not causally linked to autism, researchers continue to study the topic to better understand any potential small risks and mechanisms. Priority areas for rigorous research include:
  • Exposure measurement improvement: moving from self-reported medication use to validated biomarkers or prescription-dispensing records to reduce misclassification.
  • Better accounting for confounding: using family-based designs, Mendelian randomisation where feasible, and triangulation across multiple study types.
  • Biological plausibility: exploring mechanistic data in controlled settings while recognising limitations of animal models for complex human neurodevelopmental conditions.
Until higher-quality evidence says otherwise, regulators and professional societies are unanimous in recommending that clinical practice should not change based on the recent public claims.

Media literacy and communicating risk in the age of rapid news cycles​

The episode illustrates several broader lessons for journalists, clinicians, and public communicators:
  • Distinguish correlation from causation. Population studies that show associations are hypothesis-generating; they require careful interpretation and follow-up with stronger designs before informing public-health advice.
  • Contextualise absolute risk. Even when an association exists, the absolute increase—if any—is often small, and can be affected by confounding; journalists should report both relative and absolute numbers when possible.
  • Avoid alarmist framing. Headlines that imply definitive causation from preliminary or mixed evidence cause unnecessary panic; responsible outlets should prioritise clarity and expert comment.
  • Amplify authoritative guidance quickly. When misinformation spreads, rapid responses from health authorities (as seen from WHO and national regulators) are essential to counteract harm.

Risks and limits of the societies’ position​

While the joint statement from South African societies aligns with international guidance and is grounded in current evidence, a nuanced critique is necessary to understand limits and potential blind spots:
  • Residual uncertainty. Science rarely proves a universal negative; saying “no evidence of causation” is different from “zero possibility.” Good clinical advice recognises uncertainty while providing practical recommendations. The societies did this by urging consultation with clinicians.
  • Population differences. Most large cohort studies are from high-income countries; extrapolating results globally assumes similar patterns of dosing, infectious disease prevalence, and co-exposures. Local surveillance and context-sensitive guidance remain important.
  • Communication challenges. While medical societies counter misinformation, they must also anticipate and address public emotions and fears—statements that are purely technical can fail to reassure anxious patients. Combining evidence summaries with empathetic communication is essential.

Policy implications and the role of regulators​

The coordinated responses from regulators—MHRA in the UK, the EMA in Europe, Australia’s TGA, and the WHO—underscore how regulatory systems are designed to monitor safety signals continuously and provide measured, evidence-based guidance. Their conclusions in this episode reinforce several policy principles:
  • Continuous post-market surveillance of widely used medicines is crucial.
  • Rapid, transparent meta-analyses and regulatory reviews are needed to address noisy signals quickly.
  • Cross-agency cooperation improves public confidence by showing consensus across jurisdictions.

Conclusion​

The statements from South African medical societies that paracetamol use during pregnancy is not proven to cause autism reflect the weight of current epidemiology, sibling-controlled analyses, and international regulatory reviews. The WHO, the MHRA, EMA, and other bodies have issued similar reassurances, while consistently advising prudent, minimal effective dosing and clinician consultation when needed.
This episode is a reminder that even well-intentioned, headline-grabbing claims can have immediate and harmful consequences for patient behaviour. Where public statements touch on health risks, they must meet the same evidentiary bar that clinicians and regulators require. For now, the consensus is clear: paracetamol remains the recommended first-line option for fever and pain in pregnancy when used appropriately, and clinical practice should be guided by evidence, not assertions.
Source: EWN https://www.ewn.co.za/2025/09/24/sa-medical-societies-rubbish-claims-of-link-between-use-of-paracetamol-during-pregnancy-and-autism/
 
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