SAN FRANCISCO (KGO) — Prenatal exposure to acetaminophen increases the likelihood that a child will develop attention-deficit/hyperactivity disorder (ADHD), according to a study published Feb. 6 in Nature Mental Health.
Prior research shows that upward of 70% of pregnant women use acetaminophen during pregnancy to control pain or reduce fever. The drug, which is the active ingredient of many pain-relief medications, is one of the few considered safe to take during pregnancy by the U.S. Food and Drug Administration.
The new findings suggest, however, that doctors should reconsider prescribing medications with acetaminophen to mothers during pregnancy, the researchers said.
According to ABC’s Med Unit, there previously were already some evidence to suggest that acetaminophen use during pregnancy may be linked with neurobehavioral issues – though a definitive cause-and-effect hasn’t been established. The risk may be greater with higher doses and more frequent use of the drug, studies note.
A 2021 consensus statement published in Nature Reviews Endocrinology called for more warnings around taking these drugs during pregnancy. But neurobehavioral issues are complex, and other factors during pregnancy – like maternal stress or alcohol use – may play a role in the findings, researchers say.
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The FDA says that there are too many limitations in the research to make any changes to recommendations at this time. The FDA says that people should talk to their doctors before taking any medications during pregnancy or if they are planning to become pregnant. The FDA said in September that it would not weigh in on the ongoing lawsuits, and that they continue to conclude that there is not enough evidence to say acetaminophen causes neurobehavioral issues.
The American College of Obstetricians and Gynecologists maintains that acetaminophen is safe in moderation during pregnancy. The organization says that there is no clear direct evidence pointing to a relationship between some use of acetaminophen and neurobehavioral issues in children. “As always, any medication taken during pregnancy should be used only as needed, in moderation, and after the pregnant patient has consulted with their doctor,” ACOG said in response to the 2021 consensus statement.
“Most of the prior studies asked women to self-report whether they had taken Tylenol or anything that contained acetaminophen,” said lead author Brennan Baker, a researcher at Seattle Children’s Research Institute. Baker also works in the lab of Dr. Sheela Sathyanarayana, a UW Medicine pediatrician.
“This medication was also approved decades ago, and may need reevaluation by the FDA,” said Sathyanarayana, the paper’s senior author. “Acetaminophen was never evaluated for fetal exposures in relations to long-term neurodevelopmental impacts.”
Acetaminophen is widely used during pregnancy, with 41-70% of pregnant individuals in the United States, Europe and Asia reporting use. Despite acetaminophen’s classification as low risk by regulatory agencies such as the FDA, accumulating evidence suggests a potential link between prenatal acetaminophen exposure and adverse neurodevelopmental outcomes, including ADHD and ADHD autism spectrum disorder, the researchers noted.
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This research tracked a cohort of 307 women from 2006 to 2011, who agreed to give blood samples during their pregnancy. The researchers tracked plasma biomarkers for acetaminophen in the samples.
The children born to these mothers were followed for 8 to 10 years. Among the women who did not use acetaminophen during pregnancy, the rate of ADHD was 9%, but for the women who used acetaminophen, the ADHD rate among their offspring was 18%.
Acetaminophen metabolites were detected in 20.2% of maternal plasma samples. Children whose mothers had these biomarkers present in their plasma had a 3.15 times higher likelihood of an ADHD diagnosis compared with those without detected exposure.
The association was stronger among daughters than sons, with the daughters of acetaminophen-exposed mothers showing a 6.16 times higher likelihood of ADHD while the association was weaker and nonsignificant in males. Researchers did not know why the association was stronger in females.
The investigators’ analysis used data from the Conditions Affecting Neurocognitive Development and Learning in Early Childhood (CANDLE) research cohort, which comprised 1,031 pregnant individuals in Memphis, Tenn., who were enrolled between 2006 and 2011.
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