TGA
- Australia's Chief Medical Officer and the TGA join with other global medicines regulators, leading clinicians and scientists worldwide in rejecting claims regarding the use of paracetamol in pregnancy, and the subsequent risk of development of ADHD or autism in children.
- Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims.
- Paracetamol remains the recommended treatment option for pain or fever in pregnant women when used as directed. Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment. Pregnant women should speak to their healthcare professionals if they have questions about any medication during pregnancy.
- Paracetamol remains pregnancy category A in Australia, meaning that it is considered safe for use in pregnancy when used according to directions in TGA-approved Product Information (PI) and Consumer Medicines Information (CMI) documents.
- This means that a medicine has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed. As with the use of any medicine during pregnancy, people who are pregnant should seek medical advice tailored to their specific circumstances before taking paracetamol.
- The TGA is responsible for ensuring the safety, quality and efficacy of medicines on the Australian Register of Therapeutic Goods (ARTG), with safety in pregnancy a key consideration for all products on the ARTG.
- The TGA undertakes evaluation of clinical, scientific and toxicological data prior to registration of a medicine, and this information is summarised in TGA-approved PI and CMI documents, targeted at healthcare professionals and consumers respectively, to help support safe use of a medicine in the community. These documents include information relating to use of a medicine in pregnancy.
- The TGA is aware of announcements by the US Administration that use of paracetamol in pregnancy may be associated with an increased risk of autism and ADHD in children, though a causal association has not been established.
- TGA advice on medicines in pregnancy is based on rigorous assessment of the best available scientific evidence. Any new evidence that could affect our recommendations would be carefully evaluated by our independent scientific experts.
- Whilst there are published articles suggesting an association between maternal paracetamol use and childhood autism, they had methodological limitations. More recent and robust studies have refuted these claims, supporting the weight of other scientific evidence that does not support a causal link between paracetamol and autism or ADHD.
- The TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol. This includes detailed analysis of adverse event reports made by medicine consumers, clinicians and pharmaceutical companies, review of published medical literature, and close liaison with international medicines regulators. If a safety issue is confirmed prompt regulatory action is taken to mitigate risks.
- International peer regulators including the Medicine and Healthcare products Regulatory Agency (MHRA) in the United Kingdom have reiterated that paracetamol should continue to be used in line with product information documents. Following evaluation in 2019 the European Medicines Agency (EMA) found that scientific evidence regarding effects of paracetamol on childhood neurodevelopment was inconclusive.
- People who have concerns and are pregnant, or considering pregnancy, are advised to consult their healthcare professionals in the first instance to discuss this issue.
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