Nature Reviews Endocrinology (2021 )Cite this article
Paracetamol (N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen) is the active ingredient in more than 600 medications used to relieve mild to moderate pain and reduce fever. APAP is widely used by pregnant women as governmental agencies, including the FDA and EMA, have long considered APAP appropriate for use during pregnancy when used as directed. However, increasing experimental and epidemiological research suggests that prenatal exposure to APAP might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders. Here we summarize this evidence and call for precautionary action through a focused research effort and by increasing awareness among health professionals and pregnant women. APAP is an important medication and alternatives for treatment of high fever and severe pain are limited. We recommend that pregnant women should be cautioned at the beginning of pregnancy to: forego APAP unless its use is medically indicated; consult with a physician or pharmacist if they are uncertain whether use is indicated and before using on a long-term basis; and minimize exposure by using the lowest effective dose for the shortest possible time. We suggest specific actions to implement these recommendations. This Consensus Statement reflects our concerns and is currently supported by 91 scientists, clinicians and public health professionals from across the globe.
A growing body of experimental and epidemiological research suggests that prenatal exposure to paracetamol (N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen) might alter fetal development, which could in turn increase the risks of certain neurodevelopmental, reproductive and urogenital disorders1,2,3. APAP is the active ingredient in more than 600 prescription and non-prescription medications used to relieve mild to moderate pain and reduce fever (Consumer Health Products Association — acetaminophen). Sales of APAP-containing products, which are not restricted to pharmacies in many countries, are increasing worldwide4. Adverse effects of APAP are well known; for example, intentional overdose, unintentional overdose5,6 and chronic use have resulted in APAP being the leading cause of acute liver failure in children7 and adults5,8 in the Western world. Of note, APAP is widely used by pregnant women, as the FDA and EMA have long considered APAP-containing products to be of minimal risk when used as directed during pregnancy9,10.