AGOSS Position on the Use of Paracetamol in Pregnancy

Statement on the Position of the Association of Gynecologists and Obstetricians of South Sudan (AGOSS) on the Use of Paracetamol During Pregnancy and Its Linkage with Neurodevelopmental Disorders Among Children

September 2025

Zechariah J. Malel1,2, Idyoro J. Ojwuku1,2, Moses Maror Ayuel1,2, Garang Dakjur Lueth1,2, Jok Gang Lual1,3, Ayol Mac Ayol1, Benjamin Bol Henry1, Abdel Razik Odeil1

Author Affiliation:

  1. Association of Gynecologists and Obstetricians of South Sudan (AGOSS)
  2. School of Medicine, University of Juba
  3. School of Medicine, Upper Nile University

Correspondence: [email protected]

Background

Paracetamol, known as acetaminophen is an over-the-counter (OTC) pain reliever and fever-reducing medication. The drug is chemically named as N-acetyl-p-aminophenol, with its international brand name” Panadol”. It is classified as an analgesic (pain reliever) and also as antipyretic (fever reducer). It is produced in different formulations; these include tablets, capsules, liquid suspensions, suppositories and intravenous (IV).[1]

AGOSS understands that pregnant women in South Sudan may require safe, easily accessible, and effective medications to alleviate fever, pain, or discomfort during pregnancy. 

Based on the best available data, paracetamol (acetaminophen) is still one of the safest options for managing mild to moderate pain and decreasing fever during pregnancy, when used at approved therapeutic levels.[2]

There is presently no conclusive scientific evidence that paracetamol, when used as intended, causes neurodevelopmental abnormalities (such as autism or ADHD) in children or congenital deformities in infants.[2] There are limits to observational studies that show probable connections, such as potential confounding factors. AGOSS also acknowledged many statements on the use of acetaminophen released by well-known worldwide regulators and professional obstetrics associations.

I. In 2017, the Society for Maternal-Fetal Medicine (SMFM) “conducted an independent review of large cohort studies” and concluded there is “no clear causal relationship” between the use of acetaminophen-containing products during pregnancy and neurodevelopmental disorders in children.[2]

II. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom confirms paracetamol remains safe in pregnancy when used as directed, and that there is no evidence it causes autism.[3]

III. The European Medicines Agency (EMA) recommends that paracetamol should be used for controlling pain or fever during pregnancy if clinically necessary. It recommends utilising the lowest effective dose for the shortest possible time.[4]

IV. According to the Royal College of Obstetricians and Gynaecologists (ROCG), controlling pain and fever during pregnancy is crucial, as uncontrolled fever can pose dangers. Therefore, paracetamol is the recommended first-line pain medication when used carefully.[5]

V. FIGO also advised that healthcare providers should continue following established clinical guidelines regarding paracetamol use in pregnancy because it remains the safest analgesic option during pregnancy when used appropriately, supported by decades of clinical experience and the highest-quality epidemiological evidence.[6]

VI. In a position made by the Society of Obstetricians and Gynaecologists of Canada (SOGC) recommended the use of acetaminophen as a first line analgesic for management of pain and fever drug during pregnancy when medically prescribed with the recommended dose and for the shortest duration possible.[7]

Recommendation

I. In regards to the current available scientific evidences, AGOSS advises that paracetamol should only be used when medically indicated, i.e., when fever or pain is significant, and not as a routine measure without symptoms.

II. Dosage should follow South Sudan Ministry of Health or WHO guidelines, using the lowest effective dose for the shortest possible duration.

III. Pregnant women should consult a health professional (midwife, obstetrician, pharmacist) before using paracetamol, particularly if:

a) They are in the very early stages of pregnancy, or approaching the third trimester.

b) They are using other medications that might interact.

c) They have liver disease or other medical conditions.

IV. It is also important to consider non‐pharmacological measures for managing mild pain and fever (e.g., rest, hydration, cold compresses, cooling environment) when feasible.

Conclusion

We recommend that all healthcare providers continue to prescribe paracetamol as per clinical indications, considering the lowest possible doses in the shortest possible time.

AGOSS also commits to monitoring emerging research closely, and will update this guidance if new evidence indicates a need for change.

References 

  1. Kumar N, Prasad T, Singh S, Kumar P, Rathi R, Kumar N, et al. Paracetamol (N-acetyl-p-aminophenol, APAP) Threats: Therapeutic Clock. International Journal of Pharma Professionals Research. 2023;14. Available from: https://www.researchgate.net/publication/377752084

  2. SMFM Response to Administration Announcement on Acetaminophen Use During Pregnancy and Autism. Available from: https://www.smfm.org/news/smfm-response-to-administration-announcement-on-acetaminophen-use-during-pregnancy-and-autism
  3. Drug Safety Update (DSU) Paracetamol and pregnancy-reminder that taking paracetamol during pregnancy remains safe. 2025. 
  4. European Medicines Agency’s (EMA). PRAC recommendations on signals. Adopted 12-15 March 2019. https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-12-15-march-2019-prac-meeting_en.pdf
  5. Damkier P, Gram EB, Ceulemans M, Panchaud A, Cleary B, Chambers C, et al. Acetaminophen in Pregnancy and Attention-Deficit and Hyperactivity Disorder and Autism Spectrum Disorder. Obstetrics and Gynecology. 2025 Feb 1;145(2):168–76. 
  6. FIGO. Paracetamol (acetaminophen) use during pregnancy and autism risk: evidence does not support causal association FIGO Statement [Internet]. 2025. Available from: www.figo.org
  7. Ahlqvist VH, Sjöqvist H, Dalman C, Karlsson H, Stephansson O, Johansson S, et al. Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024 Apr 9;331(14):1205–14.