A Missouri mom believes taking a generic brand of acetaminophen while pregnant caused autism and ADHD in her child who was born in 2017. She’s now suing Walmart in federal court.

The lawsuit was filed Nov. 10 in the Western District of Missouri by Dovel & Luner, the legal team representing the mother and her son. They said her son was diagnosed with attention-deficit hyperactivity disorder and autism spectrum disorder at 5 years old, after the mom began having concerns about his development.

The mother had started taking Equate acetaminophen around July 2016, while she was pregnant.

“During the course of her pregnancy, (she) frequently took acetaminophen multiple times per week to relieve her headaches,” according to the lawsuit.

Her attorneys said there is no warning on the label that addressed the risks of autism and ADHD if a mother takes the over-the-counter drug while pregnant.

“Had (this mother) known of the risk of taking acetaminophen while pregnant, specifically that it could cause ASD and ADHD in her child, she would not have taken acetaminophen,” the lawsuit said.

A bottle of Equate acetaminophen caplets that can be bought on the Walmart website has a label that says, “If pregnant or breastfeeding, ask a health professional before use.” It does not mention specific risks that might occur if taking the drug while pregnant.

“Walmart does not manufacture these products,” a company spokesperson said in a statement to McClatchy News. “We expect suppliers to provide safe and quality products that comply with all applicable laws, including labeling requirements. We will respond in court as appropriate.”

Is taking acetaminophen risky while pregnant?

A consensus statement published in the journal Nature Reviews Endocrinology in 2021 warned that exposure to acetaminophen while in the womb could alter fetal development and increase neurodevelopmental risks.

In response to the statement, the American College of Obstetricians and Gynecologists said its doctors “have always identified acetaminophen as one of the only safe pain relievers for pregnant individuals during pregnancy.”

“This consensus statement, and studies that have been conducted in the past, show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and fetal developmental issues,” according to the ACOG.

The association said neurodevelopmental disorders are difficult to pinpoint toward one cause as a child’s brain doesn’t stop developing until they are at least 15 months old, “which leaves room for children to be exposed to a number of factors that could potentially lead to these issues.”

“ACOG’s clinical guidance remains the same and physicians should not change clinical practice until definitive prospective research is done,” the statement continued. “Most importantly, patients should not be frightened away from the many benefits of acetaminophen. However, 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.”

This statement also followed a study published in the American Journal of Epidemiology in 2018, which found that “acetaminophen use during pregnancy is associated with an increased risk for ADHD, ASD, and hyperactivity symptoms.”

“These findings are concerning; however, results should be interpreted with caution given that the available evidence consists of observational studies and is susceptible to several potential sources of bias,” the authors wrote at the time.

In a 2022 response to the study, Dr. Salena Zanotti with the Cleveland Clinic said “acetaminophen is still the safest known drug to take during pregnancy for problems like fever and pain.”

“When you’re pregnant, it’s riskier to have an untreated fever than it is to take acetaminophen,” she added.

She said more research is needed to understand “the effects of prolonged acetaminophen exposure” on unborn children.

‘Failure to warn’

The lawsuit filed in Missouri argues that the store brand of acetaminophen “was defective and unreasonably dangerous when ingested by pregnant women, who are reasonably foreseeable consumers of the drug.”

Attorneys said Walmart is responsible for a “failure to warn” consumers of these risks.

The legal team also believes Walmart violated state and federal consumer protection laws by selling a product without “adequate warnings.”

“Defendant has concealed and failed to disclose to the public the serious risks and the potential complications associated with the product, so as to ensure continued and increased sales and profits and to the detriment of the public,” Julien Adams of Dovel & Luner said in a news release. “Plaintiffs brought this lawsuit to protect future consumers and bring justice to those who have been wronged.”

They seek a jury trial and $5,000,000 in damages.

© 2022 McClatchy News
Distributed by Tribune Content Agency, LLC

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