Other safety alerts
|
| |
| Singapore: No Established Link Between Paracetamol Use During Pregnancy And Autism In Children |
| |
Health Science Authority (HSA) announces it is aware of recent US announcements suggesting a potential association between paracetamol use during pregnancy and autism in children. HSA would like to advise that there is currently no robust scientific evidence to support this claimed connection.
Paracetamol has been used worldwide for decades to manage pain and fever, including in pregnant women. It remains the recommended treatment for pain or fever in pregnant women when used as directed.
There is no conclusive scientific evidence that taking paracetamol during pregnancy causes autism in children. While some studies describe an association between paracetamol and neurological conditions such as autism, a causal relationship has not been established. Many other studies also found no such association.
HSA has a post-market surveillance programme to continually monitor the safety of medicines used in Singapore. To date, HSA has not detected any safety concerns of paracetamol use during pregnancy causing autism or other neurological issues in children.
Patients are advised of the following:
• Paracetamol can be used for reducing pain or fever during pregnancy if clinically needed. It should be used according to labelled instructions or as prescribed by healthcare professionals. Generally, it should be used at the lowest effective dose for the shortest duration needed.
• Untreated fever or pain during pregnancy can pose risks to the unborn child. Pregnant women should discuss with their healthcare professionals if they have questions or concerns about medications used during pregnancy.
HSA will continue to monitor relevant scientific evidence, safety signals and international developments in paracetamol use. We will inform healthcare professionals and members of the public if any significant safety risks are detected with medicines.
Please refer to the following website in HSA for details: http://www.hsa.gov.sg/announcements/news/no-established-link-between-paracetamol-use-during-pregnancy-and-autism-in-children
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 707 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 on 23 Sep 2025 and 26 Sep 2025.
As previously reported, letters to inform local healthcare professionals have been issued and the DH will maintain vigilant oversight of the matter, taking appropriate actions as necessary.
Ends/ Saturday, September 27, 2025
Issued at HKT 12:00
|
| |
|
