#Medicines, #Pregnancy, #Paracetamol
Due to the emergence of information about the impact of paracetamol use by pregnant women, and the risk of autism and ADHD in children, the European Medicines Agency has published an official statement in which it maintains that paracetamol is safe.
In August 2025, a publication appeared that suggested the effect of the use of paracetamol by pregnant women on neurodevelopmental disorders and the occurrence of ADHD and autism in children. The publication considered the potential link between paracetamol use and the risk of autism in children, but made it clear that the evidence does not support that paracetamol causes autism.
Source: https://ehjournal.biomedcentral.com/articles/10.1186/s12940-025-01208-0
Due to growing social concern, the European Medicines Agency (EMA) published a statement confirming the safety of the use of paracetamol in pregnant women, as well as the lack of evidence of potential neurodevelopmental disorders.
Historical outline and literature review:
1. In 2019, the European Medicines Agency’s Committee for Risk Assessment assessed the potential negative effects of paracetamol on the urinary system, reproductive system and brain development. The evidence was found to be inconclusive to confirm the risk, however, updates to the information were recommended.
2. In 2022, the UK Medicines Commission reviewed the use of drugs used in pregnant women, including paracetamol. She stated that there was no need for changes or restrictions on the use of paracetamol, however, she introduced a warning about ibuprofen recommending that it should not be used because of the risk of heart and kidney disorders in children.
3. In 2024, an analysis of births and data from the registries of 2.4 million children born in Sweden was carried out, in which more than 180 thousand children were exposed to paracetamol. There was no evidence that the use of the drug during pregnancy increases the risk of autism.
Source: https://jamanetwork.com/journals/jama/fullarticle/2817406
4. In February 2025, a global review of patients with a documented diagnosis of ADHD or autism was conducted. It was stated that there is no reason to worry.
5. In September 2025, the European Medicines Agency will issue a communication on the safety of paracetamol in pregnant women.
Source: https://www.ema.europa.eu/en/news/use-paracetamol-during-pregnancy-unchanged-eu#footnotes-79612