Paracetamol in Pregnancy Proven Safe Despite Autism Scare
Studies confirm paracetamol is safe during pregnancy despite autism link fears.
Amid concerns sparked by United States President Donald Trump’s recent caution against paracetamol use in pregnancy—citing a potential link to autism—Australia’s Therapeutic Goods Administration (TGA) has reaffirmed its safety, classifying it as a Category A drug. This designation, supported by decades of data, indicates that paracetamol, known as acetaminophen or Tylenol in the US, poses no increased risk of birth defects or fetal harm when used by pregnant women. The statement counters Trump’s advice to avoid the drug except in cases of extremely high fever, offering clarity to expectant mothers navigating pain relief options.
Paracetamol remains a cornerstone for managing pain—such as headaches and back pain—and reducing fever during pregnancy. The TGA’s position underscores its critical role, particularly in treating fevers, which, if left unchecked in early pregnancy, can lead to severe outcomes like miscarriage, neural tube defects, cleft lip and palate, or heart defects. Infections during pregnancy have also been linked to heightened autism risks, making fever management essential.
Recent research has scrutinized the purported link between paracetamol use and neurodevelopmental disorders like autism and attention-deficit hyperactivity disorder (ADHD). A 2021 international expert panel reviewed human and animal studies, issuing a cautious statement that paracetamol might affect fetal development, potentially impacting child health. However, subsequent studies have cast doubt on these concerns. A comprehensive 2024 study from Harvard University, analyzing 46 studies, found mixed results: 27 studies suggested a link between paracetamol use and neurodevelopmental issues, nine found no significant association, and four even indicated a reduced risk.
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The most robust evidence comes from a 2024 Swedish study involving nearly 2.5 million children born between 1995 and 2019. Initially, it reported a slight increase in autism and ADHD risk tied to paracetamol use. However, when researchers examined matched sibling pairs—controlling for shared genetic and environmental factors—the association vanished, showing no increased risk of autism, ADHD, or intellectual disability. This sibling-comparison approach, which accounts for familial factors like genetics and home environment, revealed that earlier findings were likely skewed by “confounding” variables, such as maternal health or socioeconomic conditions.
A February 2025 review further highlighted limitations in prior studies, noting biases in participant selection and inadequate accounting for confounding factors like maternal illnesses, body mass index, smoking, alcohol use, or pregnancy complications such as pre-eclampsia. These factors, alongside parental age, breastfeeding practices, and societal characteristics, can influence autism risk but are challenging to measure accurately. Critically, the reviews suggest that the underlying conditions prompting paracetamol use—like fevers from infections—may drive observed risks, not the drug itself.
For pregnant women, the science offers reassurance: there is no clear evidence linking paracetamol to fetal harm when used as directed. Experts advise using the lowest effective dose for the shortest duration, a standard precaution for all medications during pregnancy. “If you’re pregnant and develop a fever, it’s important to treat this fever, including with paracetamol,” noted researchers, emphasizing the risks of untreated fevers. For persistent pain or inadequate symptom relief, consulting a doctor, midwife, or maternity hospital is recommended.
The guidance contrasts sharply with that for non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Nurofen), which are contraindicated during pregnancy due to established risks of fetal complications. Paracetamol’s safety profile, backed by extensive use among pregnant women globally, positions it as the preferred choice for pain and fever management.
The debate, amplified by high-profile claims like Trump’s, underscores the complexity of studying autism’s causes. Known factors include genetics—siblings of autistic children face a 20% chance of diagnosis—and environmental influences, but no single cause fully explains the condition. Misleading correlations, often muddied by confounding variables, can fuel public concern, making rigorous research like the Swedish study vital for clarity.
As expectant mothers navigate these conflicting narratives, Australia’s medical community stands firm: paracetamol, when used judiciously, remains a safe and effective option. The TGA’s reaffirmation, coupled with robust scientific evidence, dispels fears of a paracetamol-autism link, ensuring pregnant women can prioritize their health—and their baby’s—without undue worry.
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