Taking paracetamol, known as Tylenol in the U.S., during pregnancy is safe, according to a group of European researchers. This conclusion comes after the team compiled extensive data in response to controversial claims made by former U.S. President Donald Trump regarding a potential link between the medication and autism.
The findings were published in the British journal The Lancet Obstetrics, Gynaecology & Women’s Health on Saturday. The researchers focused on assembling the best-quality evidence to address these claims, aiming to reassure pregnant women about the safety of this commonly used pain reliever.
“Paracetamol is safe to use in pregnancy,” stated lead author Asma Khalil, professor of obstetrics and maternal foetal medicine at City St George’s, University of London. “The key message is reassurance: When used as recommended, the best available evidence does not support a causal link with autism, ADHD (attention-deficit/hyperactivity disorder) or intellectual disability.”
Trump’s comments in September advised pregnant women against taking paracetamol, sparking widespread concern. National and international medical groups quickly refuted his statements, asserting they lacked an evidence-based foundation. Paracetamol is the only pain reliever deemed safe for use during pregnancy, and health professionals typically recommend the smallest effective dose for the shortest duration to manage pain and fever, conditions that can pose risks to both mothers and their babies if left untreated.
The research team conducted a systematic review and meta-analysis, evaluating 43 studies on paracetamol usage during pregnancy. These studies were rigorously assessed for quality and potential bias. Khalil noted that they particularly examined studies involving children born to the same mother, with one pregnancy involving paracetamol use and the other not. This approach accounts for shared genetic and environmental factors that could contribute to autism and other studied conditions.
While only three of the studies met this criterion, they included substantial sample sizes, covering over 260,000 children assessed for autism, and approximately 335,000 and 405,000 for ADHD and intellectual disabilities, respectively. The results showed no significant association between paracetamol use during pregnancy and the development of these conditions.
This conclusion remained consistent even when pooling results from all high-quality studies assessed in the review. Khalil pointed out that much of the previous work suggesting a potential link was susceptible to bias and confounding factors, which her team’s analysis aimed to address.
Grainne McAlonan, a professor of Translational Neuroscience at King’s College London who was not involved in the research, lauded the study’s findings. She expressed hope that this research would help to settle the ongoing debate about the safety of paracetamol during pregnancy.
