A newly published systematic review and meta-analysis in The Lancet Obstetrics, Gynecology, & Women’s Health has provided reassuring evidence regarding the safety of paracetamol use during pregnancy. The comprehensive analysis found no association between maternal paracetamol exposure and an increased risk of autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), or intellectual disability in children.
In response to these findings, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed its long-standing position that paracetamol remains the safest and most appropriate first-line treatment for pain and fever during pregnancy.
Dr Alison Cave, Chief Safety Officer at the MHRA, emphasized that the new evidence strengthens existing guidance. She noted that paracetamol has been used safely for many decades and, when taken as directed, remains both effective and well tolerated in pregnant women. Importantly, the analysis found no evidence to support concerns about long-term neurodevelopmental harm in children.
Current clinical guidance continues to recommend paracetamol as the first-choice analgesic and antipyretic in pregnancy, used at the lowest effective dose and for the shortest possible duration. Women are advised to seek medical advice if symptoms persist or if they have any concerns about medication use during pregnancy.
The MHRA also highlighted that untreated pain and fever can themselves pose risks to both the mother and the unborn child, underscoring the importance of appropriate symptom management. As part of its ongoing pharmacovigilance activities, the agency continues to monitor the safety of paracetamol through regular evidence reviews and encourages both healthcare professionals and patients to report any suspected adverse effects through the Yellow Card scheme.
As the UK’s regulatory authority for medicines and medical devices, the MHRA remains committed to ensuring that all regulatory decisions are grounded in robust scientific evidence, with patient safety and benefit at the forefront of its work.
Learn more: GovMHRA statement on new review of paracetamol safety during pregnancy
