Medical research: A precautionary approach to using paracetamol during pregnancy

Paracetamol (also called acetaminophen) should be used only when medically indicated during pregnancy and at the lowest effective dose for the shortest possible time, according to a Consensus Statement published in Nature Reviews Endocrinology. The authors call for a focused research effort to study how paracetamol may affect foetal development and propose a series of precautionary measures that should be taken in the meantime.

Paracetamol is widely used during pregnancy, with estimates suggesting that it is used by up to 65% of those who are pregnant in the United States, and over 50% worldwide. However, an increasing amount of research suggests that prenatal exposure to paracetamol may affect foetal development, which might increase the risk of certain neurodevelopmental, reproductive and urogenital disorders.

David Kristensen and colleagues conducted a review of experimental animal and cell-based research, and human epidemiological research related to paracetamol use during pregnancy published between 01 January 1995 and 25 October 2020. The authors summarize the research, reporting that prenatal paracetamol exposure in humans might be associated with adverse neurological, urogenital and reproductive outcomes in males and females. These epidemiological findings are supported by experimental studies showing adverse effects in animal and cellular models.

Based on their review and taking a precautionary approach, the authors propose that people should be counselled early on in pregnancy to forego the use of paracetamol unless medically indicated; consult with their physician or pharmacist if uncertain whether to use paracetamol and before using on a long-term basis; and minimize risk by using the lowest effective dose for the shortest possible time. While these recommendations may not differ substantially from current general pregnancy medication advice, the authors believe that paracetamol-specific risk communication is warranted to both health professionals and those who are pregnant because of the high rates of use and perceptions of negligible risk.

Kristensen and co-authors call for agencies such as the US Food and Drug Administration and the European Medicines Agency and appropriate societies to review all available data covering both epidemiological and experimental studies, so that an evidence-based evaluation of the risk can be made available to inform patients and healthcare professionals. They also make some recommendations for the design of robust future human epidemiological studies to better understand the effects of paracetamol exposure during pregnancy.