In a news conference Monday, President Donald Trump repeatedly gave medical advice to pregnant mothers: “Don’t take Tylenol.”
Trump was unveiling new guidance from the FDA that urges mothers to talk with their doctor and minimize the use of acetaminophen, the active ingredient in the popular pain reliever. The guidance points to some studies that have found a link between the drug and neurological conditions like autism and ADHD.
The announcement swiftly drew criticism and concern from many doctors and medical associations who argued Trump’s administration is misrepresenting the scientific evidence and potentially giving bad advice.
“HHS should release the new data that it has to support this claim. The preponderance of evidence shows that this is not the case,” said U.S. Sen. Bill Cassidy, the Louisiana Republican who is a doctor and chair of the committee that oversees the health department. “The concern is that women will be left with no options to manage pain in pregnancy. We must be compassionate to this problem.”
The new guidance does not go as far as Trump did in telling doctors and mothers to avoid Tylenol entirely.
“The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment,” FDA Commissioner Marty Makary said in a statement. “It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”
Here’s what to know about the new recommendations, what the research says, and what other medical experts say.
What does research on Tylenol show?
Some studies have shown a connection between acetaminophen and autism. But those studies have not proven a causal link, many experts say, meaning it’s not clear whether the drug actually caused the condition.
It’s possible, for example, that patients who used acetaminophen had other conditions, like the ones that led them to take Tylenol.
And some studies, including one published last year in the Journal of the American Medical Association, found no direct association between acetaminophen and autism or ADHD.
“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children,” wrote Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, in a statement responding to Trump’s announcement.
What are the new FDA recommendations?
“In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers,” the FDA said in a statement Monday. “This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy.”
The agency said “evidence has accumulated” that using the drug during pregnancy “may be associated with an increased risk of neurological conditions such as autism and ADHD in children,” particularly when used chronically.
“These concerns may be magnified by the fact that a very young child’s liver may still be developing and thus a child’s ability to metabolize the drug may be limited,” the statement said.
What do other experts recommend?
Many experts do caution against prolonged, high-dosage use of acetaminophen during pregnancy.
But even some researchers who have raised caution about the drug say the conditions that it addresses, like pain and fever, can be more harmful to the fetus if left untreated.
“We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk-benefit assessments, rather than a broad limitation,” a group of Harvard University researchers said in a study that flagged potential risks.
Both the FDA statement and its critics say other, similar pain relievers, like ibuprofen and aspirin, present a greater risk.
What are the politics behind this?
Trump’s announcement Monday was not the first time he and Robert F. Kennedy, the Secretary of Health and Human Services, have stirred criticism in the medical community.
Long a prominent vaccine skeptic, Kennedy fired the entire board that guides federal vaccine policy, and some of the members he appointed to replace them have a history of anti-vaccine statements. The director and other top officials at the Centers for Disease Control were fired or quit — some of them have said Kennedy pressured them to accept vaccine recommendations without solid scientific evidence.