Discussion around medication safety in pregnancy is getting a much-needed warm-up. Acetaminophen, the active ingredient in Tylenol, has become the center of these discussions. Kenvue, the pharmaceutical behemoth that produces the medication, vehemently argues that acetaminophen is necessary for pregnant people and their doctors to have available. It is the only approved medication specifically indicated for pain and fever relief during this important period. In light of recent litigation and well-publicized statements from health officials, the vaccine’s possible causal relationship to autism has been called into question.
In 2023, a federal judge in Manhattan dismissed several lawsuits that claimed a connection between acetaminophen use during pregnancy and autism due to a lack of scientific evidence. The judge’s 2024 ruling ended the expensive and unprecedented litigation. He added that when pursuing serious allegations, the burden is on the government agency to have robust scientific evidence. Despite the overwhelming evidence to the contrary, Kenvue still holds strong to its position that “independent, sound science” shows that using acetaminophen does not lead to autism.
The U.S. Food and Drug Administration (FDA) has weighed in on the topic. They concluded that there was no “clear evidence” that regular use of acetaminophen during pregnancy is connected to adverse pregnancy or developmental effects. Another large, national study, published last year in the Journal of the American Medical Association, confirmed these findings. The researchers decided that taking acetaminophen during pregnancy was not associated with autism, ADHD, or intellectual disability.
There are sharply opposing views among the physicians’ ranks. Dr. Andrea Baccarelli, dean of the faculty at Harvard T.H. Chan School of Public Health, noted that while there may be an association between acetaminophen use and autism—particularly stronger when the drug is taken for four weeks or longer—further research is necessary to “confirm the association and determine causality.”
The debate intensified when Robert F. Kennedy Jr., who now leads the Health and Human Services department, publicly undermined acetaminophen’s longstanding acceptance as a treatment. Kennedy has made autism a significant focus of his role, pledging to “know what has caused the autism epidemic” by September while vowing to eliminate exposures linked to it.
Most recently, Kenvue said it was “deeply concerned” by public perceptions about acetaminophen use in pregnancy.
“We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.” – Kenvue
In other news, President Donald Trump just made waves when he declared that FDA would release a physician’s warning on the dangers of acetaminophen use in pregnancy. He encouraged people to take reasonable steps to protect themselves. Most notably, he counseled women to avoid Tylenol unless absolutely required—in extreme cases of high fever.
“They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” – Donald Trump
Trump has long been a proponent of continued research into autism. He thinks this brings hope to families living with the disorder.
“This gives hope to the many parents with autistic children that it may be possible to improve their lives.” – Donald Trump
Our funded researchers are continuing to explore this vexing challenge head-on. They are using health records of nearly 2.5 million Swedish children to investigate the possible connections between acetaminophen and autism. This new research hopes to give clearer answers in the face of increasing worry and contradictory findings.
Kenvue maintains that acetaminophen is an essential medication for managing pain and fever during pregnancy. They argue that millions of women have used it safely and effectively for years.
As the controversy plays out, advocates and experts are already calling for further studies. They hope to better define the relationship between acetaminophen use in pregnancy and the risk of neurodevelopmental disorders. The medical community is split on how to interpret the meaning of findings from recent, preliminary research. We’ve heard too much from egg-toting experts urging against an adventurous spirit.