After President Donald Trump told pregnant women to “fight like hell” not to take Tylenol, orders for it declined among pregnant women who visited emergency departments, according to data published Thursday in the medical journal The Lancet.
Trump announced on Sept. 22 that the Food and Drug Administration would warn physicians about a potential link between Tylenol use in pregnancy and autism in children.
“Don’t take Tylenol if you’re pregnant,” he said.
The risk has not been substantiated by robust scientific evidence, and the actual letter that the FDA sent doctors said the subject was “an ongoing area of scientific debate.” A January analysis of existing research on the subject — one of the most thorough to date — found no link between Tylenol use in pregnancy and neurodevelopmental disorders, including autism.
To investigate the impact of Trump’s comments, a pair of researchers — at Harvard Medical School and Brown University — used electronic health records to compare the number of Tylenol prescriptions for pregnant patients who visited emergency departments from Sept. 22 to Dec. 7 to prescriptions ordered in the nearly three months leading up to Trump’s announcement.
They found that orders for paracetamol — the active ingredient in Tylenol — fell 10% for pregnant patients. The researchers did not see the same decline in women who weren’t pregnant.
“The most likely explanation, given this very strong and abrupt change, is the press conference changed perceptions of Tylenol use,” said Dr. Michael Barnett, an author of the Lancet paper and a professor at Brown University School of Public Health.
It’s not known from the data whether the decrease was primarily due to patients refusing Tylenol, or whether physicians were reluctant to prescribe it. However, Barnett said the former is more likely.
The American College of Obstetricians and Gynecologists considers Tylenol one of the few pain relievers and fever reducers that can be safely taken during pregnancy. The group also says that an untreated fever can pose health risks to both the mother and the baby, including an increased risk of birth defects.
Kenvue, the maker of Tylenol, said it encourages pregnant women to speak with a healthcare professional before using the medication, per the instructions on the product label. The company reiterated that there is "no credible data that shows a proven link" between Tylenol and autism.
“We remain deeply concerned about the health risks and confusion unfounded claims pose for expecting mothers and parents,” Kenvue in a statement.
It is difficult to determine the impact of Trump’s statements on over-the-counter Tylenol purchases. Kenvue reports sales trends for its business segments, rather than by individual brand. In its fourth quarter earnings, the company reported a 1.5% increase in net sales for its self-care segment, which includes Tylenol along with many other brands. Self-care sales had declined in the prior quarter.
Barnett’s team also analyzed changes in the use of another medication: leucovorin, which Trump touted at the same press conference as a way to reduce autism symptoms.
Barnett found, via electronic health records, that new prescriptions for leucovorin from doctors’ offices or telehealth visits rose 71% for children ages 5 to 17 in the two-and-a-half months after Trump’s announcement.
Leucovorin, also known as folinic acid, is a synthetic form of vitamin B9 often administered to cancer patients alongside chemotherapy. Only a handful of small trials — mostly conducted outside the U.S. — have pointed to its potential for children with autism. The American Academy of Pediatrics says more evidence is needed.
The FDA announced in September that it was in the process of updating leucovorin’s label to make it available to patients with cerebral folate deficiency, a rare neurological condition characterized by low levels of vitamin B9 in the brain. Some researchers suspect that the condition — which can affect speech, mood and behavior — is associated with autism, though not all people with autism have it.
“Prior to this, probably almost no one in the general public had any clue what leucovorin was, or that it could be understood to be helpful for some people with autism,” Barnett said. “Just making people aware that a drug exists, or a condition exists, is enough to prompt prescribing.”
In cancer patients, leucovorin has been shown to have relatively minimal side effects. However, Barnett said giving a pill to children with autism that hasn’t been proven to work for that purpose could lead to false expectations or make the drug less available for chemotherapy patients. Some forms of leucovorin are in shortage in the U.S.; however, it’s unclear whether Trump’s announcement played a role.
“The federal health authorities really do have a lot of power in capturing public health attention,” Barnett said. “All of us in the public health community want them to use this power for good, and to use the best available evidence.”
