Other safety alerts
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| European Union: Use of paracetamol during pregnancy unchanged in the EU |
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European Medicines Agency (EMA) announces that recent publication confirms no increased risk of autism, ADHD or intellectual disability. A recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women’s Health has found no evidence that using paracetamol at recommended doses during pregnancy increases the risk of autism spectrum disorder, ADHD or intellectual disability in children. This supports the existing evidence and advice that the EMA issued on the use of paracetamol during pregnancy.
In the EU, paracetamol (also known as acetaminophen) can be used for reducing pain or fever during pregnancy if clinically needed. There is currently no new evidence that would require changes to the current EU recommendations for use.
“Paracetamol remains an important option to treat pain or fever in pregnant women. Our advice is based on a rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.”- EMA’s Chief Medical Officer, Steffen Thirstrup.
As included in the product information for paracetamol in the EU, a large amount of data from pregnant women who used paracetamol during pregnancy indicates no risk of malformations in the developing foetus or in newborns.
In 2019, EMA reviewed available studies that investigated the neurodevelopment of children exposed to paracetamol in utero and found that the results were inconclusive and that no link with neurodevelopmental disorders could be established.
When needed, paracetamol can be used during pregnancy. As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest possible time and as infrequently as possible.
Pregnant women should speak to their healthcare professional if they have questions about any medication during pregnancy.
As for all medicines, EMA and the national competent authorities in the EU will continue to monitor the safety of medicines containing paracetamol and promptly evaluate any new data as they emerge. Regulatory actions will be taken as necessary to protect public health.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/use-paracetamol-during-pregnancy-unchanged-eu
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 19 Jan 2026.
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/Wednesday, Jan 21, 2026
Issued at HKT 15:00
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