MHRA Launches Paracetamol Safety Review in Pregnancy
Paracetamol should be taken as directed in the patient information leaflet.
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:
- 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.
https://www.gov.uk/government/news/mhra-statement-on-new-review-of-paracetamol-safety-during-pregnancy