Fewer pregnant women were given acetaminophen in emergency rooms after warnings from the White House
Prescriptions of acetaminophen for pregnant women fell in emergency rooms across the country after President Trump claimed at a White House briefing in September that the painkiller could cause autism, researchers reported Thursday.
The new peer-reviewed analysis, published as a research letter in the British medical journal The Lancet, examined nearly 90,000 emergency department visits by pregnant women over an 11-week period following the White House briefing.
The study found that prescriptions of acetaminophen — the active ingredient in Tylenol — fell by 10 percent before eventually appearing to rebound.
In comparison, researchers observed no change in acetaminophen prescriptions among more than 850,000 women who were not pregnant and went to the emergency room during the same period.
Medical groups, including the American College of Obstetricians and Gynecologists, have defended acetaminophen at recommended doses as the safest option for treating fever in pregnant women. Untreated fever itself is linked to an increased risk of neurological disorders in babies.
During the unusual White House briefing, the president – flanked by top health officials – urged pregnant women to avoid the painkiller and claimed it could cause autism in children. “Don’t take Tylenol. Don’t take it. Fight like hell not to take it,” Trump said.
This claim is not supported by the data. While scientists have been researching a possible connection between acetaminophen and autism for years, studies have so far produced inconclusive results. The largest studies using data from Scandinavian countries that attempted to account for genetic factors showed no association.
Andrew Nixon, a spokesman for the Department of Health, said the government’s message was “another example of its commitment to telling the truth about public health.”
The new research found the decline resulted in 22.5 fewer acetaminophen orders per 1,000 emergency department visits by pregnant women. The researchers found no increase in prescriptions of riskier pain-relieving alternatives such as opioids.
By the end of the study period in December, paracetamol prescriptions to pregnant women had returned to levels seen at the beginning of the summer.
But the number of prescriptions may still have been lower than would otherwise have been the case because acetaminophen use typically increases during cold and flu season, Dr. Jeremy Faust, an emergency physician at Brigham and Women’s Hospital and co-author of the new study.
More data is needed to better understand the full scope of the changes, he added. (Dr. Faust writes a widely read newsletter criticizing the Trump administration and federal health officials.)
Even if the decline in prescriptions was temporary, the study showed that public announcements had a significant impact in the short term, Dr. said. Aaron Kesselheim, a professor of medicine at Harvard Medical School who was not involved in the study.
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“Even if it’s the case that people move on and the news cycle moves on and people forget, these short-term spikes and dips represent many, many people,” Dr. Kesselheim.
He also warned that the snapshot was incomplete because many people take paracetamol at home, a use that is much harder to measure.
Prescriptions account for only a small portion of acetaminophen taken in the United States. Most often, people buy the drug over the counter and take it without medical supervision.
It is not clear to what extent the decline in prescriptions immediately after the press conference was due to women refusing acetaminophen or to their doctors choosing not to prescribe it.
“Ten percent isn’t a big change, but you don’t want patients who are at risk of preeclampsia or a febrile illness to go without treatment,” Dr. Nathaniel DeNicola, environmental advisor to the American College of Obstetricians and Gynecologists.
The new study chimed with his own experiences as an obstetrician who faced a wave of anxious patients in the immediate weeks after the White House briefing. The concerns quickly disappeared, he said.
“Patients have been very willing to take their doctor’s advice. And our advice has never really changed: We use Tylenol as needed, in the lowest amount and for the shortest duration,” said Dr. DeNicola.
Dr. DeNicola also noted that the new study showed that pregnant women were cautiously prescribed acetaminophen in the first place. Less than a quarter of pregnant women presenting to the emergency room had already been prescribed the painkiller before the White House announcement.
The new study also analyzed outpatient prescription data for Leucovorin, a B vitamin-based drug that has long been used to treat chemotherapy symptoms. Dr. Food and Drug Administration Commissioner Marty Makary announced at the press conference that the agency had approved Leucovorin for the treatment of autism.
This move flipped the script for the drug approval process. Typically, a pharmaceutical company carefully studies a drug and then submits this data as part of a formal application for drug approval.
For Leucovorin, the agency said it reviewed the relevant research and made the decision to recommend the drug alone.
The Lancet study also analyzed prescription data from more than 8 million doctor visits for children ages 5 to 17 and showed that outpatient leucovorin prescriptions increased 71 percent during the 11-week study period.
Although the absolute numbers are still small, representing an increase of around 17 prescriptions per 100,000 children, the immediate impact of the announcement is undeniable, said Dr. Audrey Brumback, a pediatric neurologist at the University of Texas at Austin.
“I had a few weeks there where every single patient asked about it,” said Dr. Brumback. “There are now around one to two patients per week.”
Small studies, including one that was recently retracted, suggest that the drug may improve communication skills in children with a condition called cerebral folate deficiency, in which low levels of folate in the spinal fluid can lead to deficits in motor and language development.
But this condition is rare. In an attempt to help families with their questions about Leucovorin, Dr. Brumback instead offered to conduct genetic testing to better understand what might have contributed to her altered brain development.
But the FDA’s September decision has put pressure on doctors to prescribe the drug.
“The announcement put Leucovorin on families’ radars and they started asking about it,” said Dr. Brumback. As long as families request it, “doctors will continue to prescribe it.”
