Researcher Says FDA Needs to Reevaluate Acetaminophen After Study Finds ADHD Link

Acetaminophen is used by many pregnant women to control pain or reduce fever.

Tylenol brand pain relief medicine on display at the Safeway store in Wheaton, Md., on Feb. 13, 2015. Gary Cameron/Reuters

A recent study shows that child attention-deficit/hyperactivity disorder (ADHD) risk could be linked to the mother’s use of acetaminophen, as the paper’s senior researcher warned that federal officials may need to reevaluate the commonly used medication.

A study released earlier this month shows that upward of 70 percent of pregnant women use acetaminophen—the main ingredient used in Tylenol and other over-the-counter (OTC) pain-relief medications—during pregnancy to control pain or reduce their fever.

The paper, which tracked 307 women from 2006 to 2011 who submitted blood samples during their pregnancy, looked into whether they had biomarkers showing they had taken acetaminophen. Children born to these mothers were tracked for eight to 10 years afterward.

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The ADHD rate for children of women who did not use acetaminophen was 9 percent, according to the study. The rate among children whose mothers did use acetaminophen was 18 percent.

The Food and Drug Administration (FDA) has long considered acetaminophen safe to take during pregnancy. However, the paper’s senior author said the FDA designation might need to be reevaluated in light of the study.

“This medication was also approved decades ago, and may need reevaluation by the FDA,” Sheela Sathyanarayana, the study’s senior author with the University of Washington, said in a statement on Feb. 20.

“Acetaminophen was never evaluated for fetal exposures in relations to long-term neurodevelopmental impacts.”

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Other studies on pregnant women using acetaminophen had “asked women to self-report whether they had taken Tylenol or anything that contained acetaminophen,” according to lead author Brennan Baker, a researcher at Seattle Children’s Research Institute.

In their statement, the researchers noted that there was other “accumulating evidence” that “suggests a potential link between prenatal acetaminophen exposure and adverse neurodevelopmental outcomes, including ADHD and ADHD autism spectrum disorder.”

Baker said in a statement that pregnant women are generally advised to take acetaminophen-containing medications to deal with fever instead of ibuprofen, a nonsteroidal anti-inflammatory drug, because of the risks it can pose to the fetal kidney or heart.

“[Acetaminophen] is really the only option to control fever or pain during pregnancy,” he said. “There is obviously more work that needs to be done in this area. And we need to continually update our guidance.”

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Several other studies have recently been conducted on pregnant mothers’ acetaminophen usage and ADHD.

One study recently released in Sweden shows no link between maternal acetaminophen use and ADHD in their children, while another study out of Norway found a link. However, the study out of Sweden relied on self-reported data, Baker noted.

In 2015, the FDA released a statement saying that it is “aware of and understands the concerns” about the link between acetaminophen and ADHD in children born to those women after studies had suggested that there was a connection.

“Pregnant women should always consult with their health care professional before taking any prescription or OTC medicine,” it stated. “Women taking pain medicines who are considering becoming pregnant should also consult with their health care professionals to discuss the risks and benefits of pain medicine use.”

The Epoch Times contacted the FDA for comment on Feb. 21 but did not receive a response by publication time.