Other safety alerts
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| The United Kingdom: MHRA statement on new review of paracetamol safety during pregnancy |
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Following publication of a new systematic review and meta-analysis in The Lancet Obstetrics, Gynaecology, & Women’s Health which found no evidence that paracetamol use during pregnancy increases the risk of autism spectrum disorder, ADHD or intellectual disability among children, the MHRA has reaffirmed that paracetamol continues to be the safest option for managing pain and fever during pregnancy.
Dr Alison Cave, Chief Safety Officer at the MHRA, said:
“Paracetamol remains safe to use during pregnancy. This large-scale analysis of the evidence found no link between taking paracetamol during pregnancy and autism, ADHD, or disability in children.
“Paracetamol has been used for many years and is the recommended first choice for treating pain or fever during pregnancy. When taken as directed, it is safe and effective.
“As with all medicines, pregnant women should speak to their doctor, pharmacist or midwife if they have any questions, and follow the guidance provided with the medicine.”
Notes to Editors:
• Paracetamol is recommended as the first-choice painkiller for pregnant women, used at the lowest dose and for the shortest duration. If pain does not resolve, then patients are advised to seek advice from their healthcare professional. See NHS Guidance – Pregnancy, breastfeeding and fertility while taking paracetamol for adults
• The MHRA regularly reviews the safety of paracetamol during pregnancy to ensure that the benefits to the patient and unborn baby outweigh any risks.
• Patients should not stop taking their pain medicines as untreated pain and fever can pose risks to the unborn child.
• Members of the public and healthcare professionals are encouraged to report any suspected side effect from medicines, including paracetamol, to the MHRA’s Yellow Card scheme.
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All work is underpinned by robust and fact-based judgements to ensure that benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.
Please refer to the following website in MHRA for details:
http://www.gov.uk/government/news/mhra-statement-on-new-review-of-paracetamol-safety-during-pregnancy
The Department of Health ("DH") noted that the World Health Organization ("WHO") had issued a statement on 24 September 2025 indicating that there is currently insufficient scientific evidence to conclude that paracetamol (also known as acetaminophen) use during pregnancy causes autism or other neurodevelopmental disorders in children, or that there is any association between the two. Furthermore, several drug regulatory authorities, including those in the European Union, the United Kingdom, Australia, and Canada, had also made announcements and emphasised that, based on rigorous assessments of existing scientific data, paracetamol remains an important option for pregnant women to relieve pain or fever when clinically indicated and under medical advice. Some authorities specifically noted that studies suggesting a potential link between the two exhibit significant limitations and in fact failed to establish a causal relationship. Conversely, the medical community has long confirmed through more rigorous large-scale studies that there is no association between paracetamol use during pregnancy and autism or attention deficit/hyperactivity disorder (ADHD).
Based on current scientific evidence, claims that taking paracetamol during pregnancy causes autism or other neurodevelopmental disorders in children lack sufficient supporting evidence.
In this connection, the DH issued a press statement ( http://www.info.gov.hk/gia/general/../P2025092501333.htm ) on 25 September 2025 to emphasise that all public health policies and medical advice must be based on scientific evidence.
In Hong Kong, there are 706 registered pharmaceutical products containing paracetamol (acetaminophen). So far, with regard to paracetamol, the DH has received 59 cases of adverse drug reaction, but these cases were not related to autism and ADHD in children associated with pregnancy use. Related news was previously issued by the WHO and various overseas drug regulatory authorities, and was posted on the Drug Office website since 23 Sep 2025, with the latest update posted on 27 Sep 2025.
As previously reported, letters to inform local healthcare professionals on the above WHO announcement have been issued on 26 Sep 2025 and the DH will maintain vigilant oversight of the matter, and will take appropriate actions as necessary.
Ends/Monday, Jan 19, 2026
Issued at HKT 14:00
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