While multiple studies show associations, scientists caution that a direct cause-and-effect relationship has not been established.
Published Sep 24, 2025 | 9:31 AM ⚊ Updated Sep 24, 2025 | 9:31 AM
Paracetamol. (iStock)
Synopsis: The US FDA announced plans to update the safety label for paracetamol to reflect studies suggesting a possible association between prenatal use and neurodevelopmental conditions. Research has suggested a potential link between acetaminophen use during pregnancy and an increased risk of neurodevelopmental disorders, but scientists caution that a direct cause-and-effect relationship has not been established.
The United States Food and Drug Administration (FDA) announced plans to update the safety label for acetaminophen (commonly known as paracetamol or Tylenol) to reflect studies suggesting a possible association between prenatal use and neurodevelopmental conditions, including autism and ADHD.
The move has drawn public attention after US President Donald Trump urged pregnant women to avoid Tylenol, linking it to autism, a claim experts, including former World Health Organisation (WHO) Chief Scientist Dr Soumya Swaminathan, have called misleading.
Research over the past decade has suggested a potential link between acetaminophen use during pregnancy and an increased risk of neurodevelopmental disorders, such as autism spectrum disorder (ASD) and ADHD (attention-deficit/hyperactivity disorder), particularly when used repeatedly or in the later stages of pregnancy.
While multiple studies show associations, scientists caution that a direct cause-and-effect relationship has not been established.
The FDA’s label update is intended as a precautionary measure to inform doctors and parents, highlighting the need to weigh the benefits of treating pain or fever against potential, though not conclusively proven, risks.
The updated label aims to guide physicians and pregnant women. Commissioner Marty Makary noted, “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen.” While the label highlights these associations, the agency emphasised that the ultimate choice remains with parents.
The FDA clarified that “while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established.” Some studies show no link, and scientific debate continues over the data’s interpretation. The agency described this as an ongoing area of research and stressed careful clinical decision-making.
Acetaminophen remains “the only over-the-counter drug approved for use to treat fevers during pregnancy,” highlighting its relative safety compared with alternatives such as aspirin or ibuprofen, which carry well-documented fetal risks.
The FDA also noted that most low-grade fevers do not require medication, but when treatment is necessary, acetaminophen can be used under medical supervision.
In guidance to physicians, the FDA advised that clinicians should “consider minimising the use of acetaminophen during pregnancy for routine low-grade fevers,” while balancing benefits for medically necessary cases.
Doctors are encouraged to counsel patients on proper dosing, limit the duration of use, and monitor for combination medications to avoid accidental double-dosing. The recommendations aim to help parents make informed decisions, weighing potential risks against the health risks of untreated fever or pain.
Acetaminophen, or paracetamol, is widely used globally, including in India, as the first-line treatment for fever and pain. Speaking to South First, Dr Akhil Raj, Neuro & Spine Surgeon and Research Head at the Nonpareil Centre for Neuro & Psychosomatic Development in Bengaluru, noted that research linking prenatal paracetamol use to neurodevelopment disorders is not new.
“The American College of Obstetricians and Gynaecologists (ACOG) has recognised potential risks from misuse of acetaminophen during pregnancy for nearly two decades,” he explained.
Multiple studies suggest a possible association between prenatal exposure, particularly in the third trimester, and conditions such as ASD and ADHD.
Extended or high-dose use may lead to mild developmental delays, language delays, hyperactivity, and attention issues. Dr Raj highlighted, “Prenatal paracetamol intake, especially during the third trimester, may decrease hematopoietic stem cells in cord blood, causing kidney problems, low amniotic fluid, and complications in lung, digestive, and muscle development.”
Dr Raj explained, “Taking paracetamol in the right dose and under medical supervision is helpful, but misuse can harm both mother and child.”
In India, paracetamol is extremely common in households, often used even for mild fever. Dr Raj noted, “Anybody with any pain, slight headache, or small fever uses paracetamol just like chocolate.” Its easy availability and perceived safety contribute to widespread self-medication.
Fever is a vital part of the immune response. “Fever is not just a symptom; it is your immune system reacting to incoming pathogens,” Dr Raj explained.
Suppressing fever too early can impair the function of T and B cells, reducing the child’s ability to fight infections and develop acquired immunity.
International guidelines recommend treating fevers only when necessary, typically above 102°F (38.8°C), but in India, paracetamol is often given at 99–100°F. Early intervention can compromise immune development, potentially weakening children’s immunity over time.
Parents are encouraged to use non-medication approaches first, including adequate hydration, rest, lukewarm sponge baths, and light clothing. Dr Raj also stressed monitoring underlying conditions, particularly for mothers with liver or kidney issues or those consuming alcohol.
Awareness and education are key: Parents should avoid casual or prolonged use of paracetamol and consult healthcare professionals to ensure it is administered only when medically necessary.
Highlighting the potential neurodevelopment effects in early childhood, Dr Raj said, “In susceptible children, repeated paracetamol doses during fever can disrupt endocannabinoid tone, affecting neuronal guidance and immune function, potentially contributing to autism spectrum traits,” he explained. The risk increases with prolonged or repeated use.
He advised physicians to guide parents carefully: “Paracetamol should not be used casually for mild discomfort; it should be reserved for medically indicated situations.”
“Use the minimum effective dose for the shortest duration and avoid self-medication. Parents should check combination drug labels to prevent double-dosing and consider non-drug therapies where possible.”
Dr Raj supported the FDA’s label update, describing it as “a risk-management strategy to make parents and doctors aware of potential risks. Given that 1 in 31 children in the USA is autistic, timely awareness and careful use are crucial.”
With informed guidance and responsible use, paracetamol remains a safe option for medically necessary cases while protecting maternal and child health.
(Edited by Muhammed Fazil.)
