Long-Term Safety of Prenatal and Neonatal Exposure to Paracetamol: A Systematic Review

Ram Patel, Katelyn Sushko, John van den Anker and Samira Samiee-Zafarghandy
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Ram Patel: Department of Medical Sciences, Schulich School of Medicine and Dentistry, Western University, London, ON N6A 5C1, Canada
Katelyn Sushko: Faculty of Health Sciences, School of Nursing, McMaster University, Hamilton, ON L8S 4K1, Canada
John van den Anker: Division of Clinical Pharmacology, Department of Pediatrics, Children’s National Health System, Washington, DC 20010, USA
Samira Samiee-Zafarghandy: Division of Neonatology, Department of Pediatrics, McMaster Children’s Hospital, McMaster University, Hamilton, ON L8S 4K1, Canada

IJERPH, 2022, vol. 19, issue 4, 1-26

Abstract: Introduction: Paracetamol is the most commonly used antipyretic and analgesic in pregnancy. It is also increasingly used off-label in the neonatal intensive care unit. Despite the frequent use of paracetamol, concerns have been raised regarding the high variability in neonatal dosing regimens and the long-term safety of early life exposure. Objective: To investigate the available evidence on the long-term safety of prenatal and neonatal paracetamol exposure. Methods: We conducted a systematic search of the electronic databases Ovid Medline, Ovid Embase and Web of Science from inception to August 2021 for original research studies of any design that described the use of paracetamol in the prenatal or neonatal (within the first four weeks of life) periods and examined the occurrence of neurodevelopmental, atopic or reproductive adverse outcomes at or beyond birth. Results: We identified 1313 unique articles and included 30 studies in the final review. Of all studies, 27 (90%), two (7%) and one (3%) were on the long-term safety of prenatal, neonatal and both prenatal and neonatal exposure, respectively. Thirteen (46%), 11 (39%) and four (15%) studies examined neurodevelopmental, atopic and reproductive outcomes. Eleven (100%), 11 (100%), and three (27%) studies on prenatal exposure reported adverse neurodevelopmental, atopic and reproductive outcomes. Only one study found a possible correlation between neonatal paracetamol exposure and long-term adverse outcomes. Conclusions: The available evidence, although limited, suggests a possible association between prenatal paracetamol exposure and an increased risk of neurodevelopmental, atopic and reproductive adverse outcomes. There is an immediate need for robust data on the long-term safety of paracetamol exposure in the prenatal and neonatal periods.

Keywords: paracetamol; acetaminophen; neurodevelopment; atopic disorders; reproductive disorders; neonatology; pharmacology (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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