A federal judge has ruled that the numerous lawsuits brought against the makers of Tylenol and generic acetaminophen lack sufficient “admissible evidence” to support claims that prenatal exposure to the medication can lead to autism or ADHD. U.S. District Judge Denise Cote’s opinion stated that one of the experts provided by the plaintiffs selectively presented study results and ignored the role of genetics in the development of these conditions.
This ruling aligns with the stance of major medical bodies, which assert that the available evidence does not establish a cause-and-effect relationship between acetaminophen use during pregnancy and autism or ADHD in children. While some studies suggest a potential link between acetaminophen and neurobehavioral issues, a definitive connection has not been established. The risks may be greater with higher doses and frequent use.
In 2021, a consensus statement published in Nature Reviews Endocrinology called for increased warnings about taking these drugs during pregnancy. However, researchers note that neurobehavioral issues are complex, and other factors such as maternal stress and alcohol use may contribute to the findings.
The American College of Obstetricians and Gynecologists (ACOG) maintains that acetaminophen is safe for pregnant women in moderation. According to ACOG, there is no direct evidence linking limited acetaminophen use to neurobehavioral issues in children.
The U.S. Food and Drug Administration (FDA) has declined to take a stance on the ongoing lawsuits, citing insufficient evidence to support the claim that acetaminophen causes neurobehavioral issues. The FDA advises women to consult with their doctors before taking any medications during pregnancy or when planning to conceive.
Johnson & Johnson Consumer Inc., the maker of Tylenol, stated that the court’s ruling is in line with the FDA’s position and the assessments of leading medical organizations. They plan to seek dismissal of these lawsuits, pointing out the potential negative impact on public health if scientific guesswork informs medical decision-making in courtrooms. They stress that healthcare professionals, rather than lawyers, are best placed to advise patients on acetaminophen use based on their specific medical conditions.
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