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.
Highlights
Paracetamol is the most commonly used antipyretic and analgesic in pregnancy
Studies on the long-term safety of prenatal exposure to paracetamol comprised the majority of the included studies (n = 27, 90%) [23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49], with two studies reporting on the long-term safety of neonatal exposure to paracetamol (7%) [50,51]
The ecologic study that examined the association between neonatal paracetamol exposure and neurodevelopmental adverse outcomes demonstrated a correlation between neonatal exposure to paracetamol and neurodevelopmental adverse outcomes
Summary
Paracetamol is the most commonly used antipyretic and analgesic in pregnancy. It is 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. Paracetamol, the most frequently used drug in pregnancy, is one of the most common medications used off-label in the neonatal intensive care unit (NICU). In 2010, paracetamol was the fifteenth most commonly used medication in NICUs in the United States. A recent study of European NICUs found that it is the third most frequently administered drug, prescribed to over 65% of extremely preterm neonates [2].
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