The Debate Over Paracetamol and Autism
In September, US President Donald Trump made headlines by linking paracetamol to autism in children, advising pregnant women to “fight like hell” to avoid taking the common painkiller. This statement sparked a global debate about the safety of paracetamol during pregnancy. In response, a new in-depth review published inThe BMJhas examined existing evidence and found no clear link between paracetamol use during pregnancy and autism or attention-deficit/hyperactivity disorder (ADHD) in children.
The study was conducted by researchers from major universities and institutions in the UK, Australia, and Spain. It was designed to address the recent controversy surrounding the drug’s safety and adds to growing reports from scientists and regulatory agencies that affirm its safety.
“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, one of the study’s authors and a women’s health professor at the University of Liverpool. “What is the quality behind it? And how do we actually interpret the totality of evidence, so that it helps health care providers convey this information to mothers and their families?”
Analysis of Existing Research
TheBMJreview analyzed nine existing systematic reviews on the topic to assess the overall quality and scientific validity of the claims. All nine reviews reported a link between paracetamol use during pregnancy and autism or ADHD in children. However, the researchers found that many of these studies did not adjust for important health and lifestyle factors, and that many multi-study reviews were of poor quality.
Seven of the nine reviews advised caution when interpreting their findings due to the potential risk of bias and the impact of confounding factors that could affect the results. The researchers concluded that confidence in the findings on the topic is “low to critically low,” meaning the existing evidence is not scientifically sound enough to prove that paracetamol causes these conditions.
Potential Influences on the Results
TheBMJreview suggests that any relationship between paracetamol and neurodevelopmental conditions 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 taken into account, the association between paracetamol and the risk of autism and ADHD in childhood disappeared or significantly dropped.
Paracetamol, also known as acetaminophen, is a common pain reliever sold under the brand name Tylenol in the United States. It is one of the only over-the-counter medicines recommended for pregnant women to treat pain and fever.
To coincide with Trump’s news conference in September, the US Food and Drug Administration (FDA) recommended changing the labels on paracetamol packaging 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.”
Calls for More High-Quality Research
TheBMJreview encouraged more high-quality studies on the topic that take into account other factors that could skew the results. Researchers said that would help improve the quality of the evidence on how timing and duration of paracetamol exposure may affect fetal development.
Meanwhile, Thangaratinam emphasized that making health policy decisions based on inconclusive evidence can have serious consequences. She stressed the need for more research that prioritizes women’s health specifically.
“There is a sex and gender gap in science, and studies such as this actually highlight the need for prioritisation and investment in 51 per cent of the population, especially during pregnancy,” she said.