Potential neurodevelopmental risks associated with prenatal Tylenol/acetaminophen (APAP) exposure.

Main problem

Epidemiological studies consistently suggest that prenatal acetaminophen (APAP) exposure might increase the risk of adverse neurodevelopmental and behavioral outcomes, such as ADHD, ASD, language delay (in girls), and decreased intelligence quotient.1 Fetal APAP exposure has been demonstrated to induce changes in neurotransmission in the brain, manifesting in altered cognitive function, behavior, and locomotion.1

Global Acetaminophen Market

Sales of APAP-containing products were increasing worldwide,4 meanwhile, rates of neurological, urogenital, and reproductive disorders as well as the number of children with cognitive, learning, and/or behavioral problems are increasing,.

The U.S. National Health Interview Survey reported that between 2009 and 2017, approximately one in six children aged 3 to 17 years had a developmental disability diagnosis.4

In the United States, it is estimated that APAP is used by up to 65% of pregnant women. Worldwide, it is estimated that more than 50% of pregnant women use APAP.1

However, eight out of ten women take at least one prescription or over-the-counter medicine during their pregnancy, thus, APAP use might be under-reported. One study showed that when asked about pharmaceutical use, many pregnant women did not report APAP use unless specifically asked. 1

What is APAP?

N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen, is the active ingredient in more than 600 prescription and non-prescription medications, such as Tylenol, Mapap, and Panadol, used to relieve mild to moderate pain and reduce fever. 1

Legal problem

There are currently at least 19 Tylenol/acetaminophen Autism and ADHD lawsuits filed in U.S. District Courts nationwide. All these cases raise similar allegations that various manufacturers and distributors of drugs containing acetaminophen—which is the active ingredient in Tylenol—failed to warn about the risks of Autism and ADHD associated with prenatal exposure to acetaminophen.

Tylenol/acetaminophen lawsuits are now being brought against major retailer Johnson and Johnson and generic acetaminophen manufacturers, claiming that they failed to warn that using the popular drug during pregnancy could lead to Autism.8

1. Bauer, AZ., et al. Paracetamol use during pregnancy–a Call for precautionary action. Nat. Rev. Endocrinol. 17, 757–766 (2021)
2. Bauer, AZ. et al. Prenatal paracetamol exposure and child neurodevelopment: a review. Horm. Behav. 101, 125–147 (2018).
3. Markets and Research. Global Acetaminophen Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2026. Marketsandresearch.biz https://www.marketsandresearch.biz/report/43101/global-acetaminophen-market-2020-by-manufacturers-regions-type-and-application-forecast-to-2026 (2020).
4. Zablotsky, B. et al. Prevalence and trends of developmental disabilities among children in the US: 2009–2017. Pediatrics 144, e20190811 (2019).
5. Yuelong, JI. et al. Association of cord plasma biomarkers of in utero acetaminophen exposure with risk of attention-deficit/hyperactivity disorder and autism spectrum disorder in childhood. JAMA Psychiatry. 77, 180–189 (2020).
6. Baker, BH. et al. Association of prenatal acetaminophen exposure measured in meconium with risk of attention-deficit/hyperactivity disorder mediated by frontoparietal network brain connectivity. JAMA Pediatr. 174, 1073–1081 (2020).
7. About Lawsuits. Extension Granted For Responses to MDL Motion for Acetaminophen Autism, ADHD Lawsuits. Retrieved from https://www.aboutlawsuits.com/acetaminophen-autism-mdl-extension/ (2022).
8. Yuelong JI, (2020). “Cord Plasma Biomarkers of in Utero Acetaminophen Exposure and ADHD and ASD Risk.” JAMA Psychiatry, JAMA Network. Retrieved from https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2753512
9. Miller & Zois, LLC https://www.lawsuit-information-center.com/tylenol-autism-lawsuit.html (2022)
10. Claudia, BAG. et al. Acetaminophen use in pregnancy and neurodevelopment: attention function and autism spectrum symptoms. Int. J. Epidemiol. 45, 6, 1987–1996 (2016)

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