An in-depth review found no quality evidence of a link between paracetamol use during pregnancy and autism or ADHD diagnosis in children. Since US President the President linked paracetamol to autism in September — telling pregnant women to “fight like hell” to avoid taking the common painkiller — the global scientific community has debated the claim. A new review published in The BMJ on Monday found no clear link between paracetamol use during pregnancy and autism or ADHD diagnoses in children.
The researchers from major universities and institutions in the United Kingdom, Australia, and Spain conducted the review in response to the debate over paracetamol safety during pregnancy. It adds to reports from scientists and regulatory agencies that affirm the drug is safe. “We wanted to do a review of all the reviews in the space to make sense of what the evidence is so far,” said Shakila Thangaratinam, a women’s health professor at the University of Liverpool. “What is the quality behind it? And how do we interpret the totality of evidence, so that it helps health care providers convey this information to mothers and their families?”
In the BMJ analysis, researchers evaluated nine existing systematic reviews to assess quality and scientific validity. All nine reviews reported a link between paracetamol use in pregnancy and autism or ADHD in children. However, the BMJ researchers found many studies did not adjust for important health and lifestyle factors, and several multi-study reviews were of poor quality. Seven of the nine reviews advised caution when interpreting findings due to potential bias and confounding factors.
The authors concluded that confidence in the findings on the topic is “low to critically low,” meaning existing evidence is not scientifically sound enough to prove causation. The BMJ review suggests that any relationship could be partly driven by genetic and environmental factors, or other variables such as parents’ mental health, background, and lifestyle. In the few studies where these factors were accounted for, the association between paracetamol and autism or ADHD disappeared or reduced significantly.
Paracetamol, also known as acetaminophen, is a common pain reliever sold under the brand Tylenol in the United States. It remains one of the few over-the-counter medicines recommended for pregnant women to treat pain and fever. To coincide with Trump’s September news conference, the US Food and Drug Administration (FDA) recommended changing labels to note the “evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.”
The BMJ review called for more high-quality studies that account for other factors and better illuminate how timing and duration of exposure may affect fetal development. Thangaratinam emphasized that health policy decisions based on inconclusive evidence can have serious consequences and urged research prioritizing women’s health during pregnancy. “There is a sex and gender gap in science, and studies such as this highlight the need for prioritization and investment in 51 per cent of the population, especially during pregnancy,” she said.
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