Key takeaways:
- A JAMA study analyzing over 2.5 million children in Sweden found no link between acetaminophen use during pregnancy and the risk of autism, ADHD, or intellectual disability.
- While models without sibling control suggested a slight increase in risk for these neurodevelopmental disorders with acetaminophen use, sibling control analyses showed no evidence of such association.
- Investigator Renee M. Gardner, PhD, from Karolinska Institutet, suggests these findings may offer reassurance to expectant parents considering acetaminophen use for pain or fever management during pregnancy.
A newly published study has found that there is no link between acetaminophen use during pregnancy and the risk of children developing a neurodevelopmental disorder, despite a previous consensus statement cautioning its use during pregnancy.1
Acetaminophen is one of the most commonly used drugs for managing pain and fever in pregnancy, with both the FDA and European Medicines Agency deeming the drug to pose minimal risk when used during pregnancy.2,3
However, a 2021 consensus statement supported by 91 scientists, clinicians, and public health professionals, cautioned the use of paracetamol (N-acetyl-p-aminophenol [APAP] or acetaminophen) during pregnancy, citing “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.”4
A recently published JAMA study sought to investigate the use of acetaminophen during pregnancy and the risk of autism, attention-deficit/hyperactivity disorder (ADHD), and intellectual disability in approximately 2.5 million children in Sweden from 1995 to 2019.1
Results of the analysis showed 7.49% (n = 185,909) of children were exposed to acetaminophen during pregnancy. Also, crude absolute risks at 10 years for children not exposed vs children exposed to acetaminophen were 1.33% vs 1.53% for autism, 2.46% vs 2.87% for ADHD, and 0.70% vs 0.82% for intellectual disability.1
Additionally, in models without sibling control, ever-use vs no use of acetaminophen during pregnancy was associated with a slight increased risk of autism (hazard ratio [HR], 1.05 [95%CI, 1.02-1.08]; risk difference [RD] at 10 years of age, 0.09% [95%CI, −0.01% to 0.20%]), ADHD (HR, 1.07 [95%CI, 1.05-1.10]; RD, 0.21% [95%CI, 0.08%-0.34%]), and intellectual disability (HR, 1.05 [95%CI, 1.00-1.10]; RD, 0.04%[95%CI, −0.04%to 0.12%]).1
Matched full sibling pairs were also analyzed to address unobserved confounding, according to the authors. Further results showed that sibling control analyses found no evidence that acetaminophen use during pregnancy was linked with autism (HR, 0.98 [95%CI, 0.93-1.04]; RD, 0.02%[95%CI, −0.14%to 0.18%]), ADHD (HR, 0.98 [95%CI, 0.94-1.02]; RD, −0.02%[95%CI, −0.21% to 0.15%]), or intellectual disability (HR, 1.01 [95%CI, 0.92-1.10]; RD, 0%[95%CI, −0.10% to 0.13%]).
“This study’s findings may be welcome news for birthing people who use acetaminophen as a pain or fever management option since there are few safe alternatives for relief available,” said investigator Renee M. Gardner, PhD, Karolinska Institutet.5 “We hope that our results provide reassurance to expectant parents when faced with the sometimes fraught decision of whether to take these medications during pregnancy when suffering from pain or fever.”
References:
1. Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024;331(14):1205–1214. doi:10.1001/jama.2024.3172
2. US Food and Drug Administration. FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy. January 9, 2015. Accessed March 19, 2024. https://www.fda. gov/drugs/drug-safety-and-availability/fda-drugsafety-communication-fda-has-reviewed-possible-risks- pain-medicine-use-during-pregnancy
3. Pharmacovigilance Risk Assessment Committee. PRAC recommendations on signals: adopted at the12-15 March 2019 PRAC meeting. European Medicines Agency. April 8, 2019. Accessed March 19, 2024. https://www.ema.europa.eu/en/documents/pracrecommendation/ prac-recommendations-signalsadopted- 12-15-march-2019-prac-meeting_en.pdf
4. Bauer AZ, Swan SH, Kriebel D, et al. Paracetamol use during pregnancy: a call for precautionary action. Nat Rev Endocrinol. 2021;17(12):757-766. doi:10.1038/s41574-021-00553-7
5. No Link Between Acetaminophen Use During Pregnancy and Children’s Risk Of Autism, ADHD, And Intellectual Disability Says Large Sibling Study From Drexel University And Sweden’s Karolinska Institutet. EurekAlert! April 9, 2024. Accessed April 9, 2024. https://www.eurekalert.org/news-releases/1040161
This article was initially published by our sister publication, Contemporary OB/GYN®.
