Trump asks women to ‘fight like hell’ not to take Tylenol as FDA announces autism risk
The U.S. Food and Drug Administration (FDA) sent a notice to physicians Monday, alerting them to an upcoming label change that will advise women against taking acetaminophen, the generic for Tylenol, during pregnancy. According to the agency, use of the drug during pregnancy "may be associated with an increased risk of neurological conditions," namely autism and ADHD.
While the agency noted there are studies that show an "association between acetaminophen and neurological conditions," no causal connection has been found. However, its warning is based on some research showing that an autism or ADHD diagnosis in childhood may be linked to maternal acetaminophen use, specifically a 2020 study that found higher levels of acetaminophen in umbilical cord blood at birth were correlated to a dose-dependent increase in risk of these neurological conditions. [1]
That study used data from the Boston Birth Cohort and was published in JAMA Psychiatry.
The FDA also pointed to the 2019 Nurses' Health Study II that found frequent use of the popular over-the-counter painkiller during pregnancy was linked to ADHD and autism, with the researchers unable to account for other explanations. [2]
Yet, as the FDA noted, other research contradicts these findings, including a 2024 Swedish birthing data study that looked to see if maternal use of acetaminophen was correlated with childhood autism and found no connection. [3]
Confusing things further, the statement from the FDA seems to openly acknowledge that the only over-the-counter medication approved to treat fever during pregnancy is acetaminophen, meaning that a large majority of expectant mothers likely take it. They also acknowledged that “aspirin and ibuprofen have well-documented adverse impacts on the fetus,” leaving pregnant women with little alternative.
The FDA was clear in its letter to doctors that it does not intend to yank approval for maternal acetaminophen use, and is instead issuing a clinical advisory to minimize dosages.
"The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen," FDA Commissioner Marty Makary, MD, said in a statement. "Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment."
"It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios," he added.
Trump holds press conference
The seemingly rushed nature of the FDA’s statement may be explained by a press conference held the same day by President Donald Trump, where he seemed to announce an unproven causal link between autism and Tylenol.
"Don’t take Tylenol. Fight like hell not to take it," Trump said with HHS Secretary Robert F. Kennedy Jr. standing behind him.
"Taking Tylenol is not good. I'll say it. Not good," Trump added. He also urged researchers to ramp up studies, something Kennedy confirmed all agencies of the HHS are actively doing.
In response, the American College of Obstetricians and Gynecologists (ACOG) was quick to release its own statement, calling the President’s comments and the FDA’s letter “irresponsible when considering the harmful and confusing message they send to pregnant patients.”
"Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children," Steven Fleischman, MD, President of ACOG, said. "It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data."
Fleischman said that ACOG maintains a position that acetaminophen is safe to use during pregnancy.
"When considering the use of medication in pregnancy, it’s important to consider all potential risks along with any benefits," he added. "The data from numerous studies have shown that acetaminophen plays an important—and safe—role in the well-being of pregnant women."
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.