Safety of Tylenol

SOGC Position Statement on the use of Acetaminophen for Analgesia and Fever in Pregnancy 

In 2021, the Society of Obstetricians and Gynaecologists of Canada (SOGC) issued a position statement recommending the use of acetaminophen as a first-line therapeutic option for fever and pain in pregnancy when medically indicated at recommended doses for the shortest duration required. Since then, multiple commentaries in scientific journals and reports from previously trustworthy organizations have questioned the safety of acetaminophen in pregnancy, linking, without any new supporting evidence, fetal exposure to acetaminophen to increased risks of some neurodevelopmental, reproductive, and urogenital disorders. Early this week, media outlets began reporting that the US Department of Health and Human Services plans to release a new report that definitively links prenatal exposure to acetaminophen to autism spectrum disorder (ASD), even as the data refutes this. The SOGC, as well as a number of other international societies, recognizes that the evidence for this claim of causality is weak and has many fundamental flaws. 

In light of this, the SOGC revisited the evidence and re-affirmed our recommendation: The SOGC recommends the use of acetaminophen as a first-line therapeutic option for fever and pain in pregnancy when medically indicated at recommended doses for the shortest duration required

The controversy regarding the association between in utero exposure to acetaminophen and adverse neurological outcomes in the child, including ASD and attention deficit-hyperactivity disorder, is not new. Available studies have been critically analyzed previously by scientific and regulatory bodies, including the Society of Maternal Fetal Medicine and the U.S. Food and Drug Administration. These critical reviews concluded that the evidence for causality is weak and that the results of the studies claiming a causal link should not alter current clinical practice. Recent findings provide further support that acetaminophen does not increase risks in pregnancy.

Reputable medical organizations, including the European Network of Teratology Information Services and the American College of Obstetrics and Gynecology, have firmly stated that current clinical practice should not be altered and that acetaminophen should continue to be used for managing fever and/or pain in pregnancy, when indicated. The SOGC’s current opinion, based on the available evidence, agrees with this recommendation. 

The benefits of acetaminophen for fever or pain in pregnancy are well recognized, as is the lack of safer alternatives in pregnancy. Untreated fever has been associated with miscarriage, fetal organ malformations, fetal cardiovascular complications, and even Autism Spectrum Disorder. Untreated pain can lead to depression, anxiety, and high blood pressure, which also have adverse effects on pregnancy. Access to effective pain management is considered a human right, which women should not be denied just because they are pregnant.

The SOGC is committed to ensuring that its recommendations are grounded in the most current and high-quality evidence, so that pregnant women and their providers can feel secure in their decisions. Opinions based on limited or flawed evidence should not promote unwarranted fear and guilt in pregnant women. 

Women are encouraged to discuss any concerns regarding therapeutics in pregnancy with their health care provider.