President Trump and top health officials Monday said pregnant women should not take acetaminophen for pain relief due to a potential risk of autism, despite no new evidence proving the drug directly causes it.
Acetaminophen is the active ingredient in Tylenol, one of the most widely used medications in the world.
“Taking Tylenol is not good,” Trump said during a White House announcement.
Trump spoke in the Oval Office alongside Health Secretary Robert F. Kennedy Jr, Food and Drug Administration Commissioner Marty Makary, National Institutes of Health Director Jay Bhattacharya and Centers for Medicare & Medicaid Services Administrator Mehmet Oz.
Trump and Kennedy said the Food and Drug Administration (FDA) will begin updating the label on acetaminophen and notifying physicians that Tylenol “can be associated with a very increased risk of autism.”
Trump recommended that pregnant women limit use of acetaminophen except in case of an extremely high fever — “if you can’t tough it out.”
“Fight like hell not to take it,” he said.
Tylenol has been one of the only over-the-counter pain medications for pregnant women that is considered safe. Other options like ibuprofen or aspirin can increase risks of birth defects.
To back up their claims, administration officials cited a recently published National Institutes of Health-funded review by Mount Sinai and Harvard researchers, which said their analyses of previous studies “support evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence” of neurodevelopmental disorders.
But the review did not establish a casual link between the medication and autism.
Tylenol manufacturer Kenvue issued a statement Sunday strongly disputing any link between autism and acetaminophen use during pregnancy.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” the company said.
“Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”
Experts say there are multiple causes of autism, and the increase in diagnoses is more likely due to improved detection.
Kennedy on Monday dismissed that notion, saying, “there’s been study after study on it that completely debunks that” theory. He reiterated his argument that he hasn’t seen people of his generation and older with profound autism. The first person formally diagnosed with autism received his diagnosis 11 years prior to Kennedy’s birth.
Former FDA Commissioner Scott Gottlieb said on CNBC Monday there is no clear evidence Tylenol use in pregnant women causes autism, though the issue is “worthy of further study.”
Trump also called for pregnant women to space out their vaccinations, referencing the recent vote by the Advisory Committee on Immunization Practices to no longer recommend the combined MMRV vaccine, which helps prevent measles, mumps, rubella and varicella, better known as chickenpox.
“I think when you go through the shot, you do it over a five-time period. Take it over five times or four times, but you take it in smaller doses, and you spread it out over a period of years,” said Trump.
“The chickenpox is already separate, because when that got mixed in, I guess they made it for a while, it really was bad,” Trump said. “So, they make chickenpox individually. They’re okay when you mix them, something maybe happens.”
During the briefing, Food and Drug Administrator Marty Makary said the administration would be promoting leucovorin, a form of the B vitamin folic acid, as a way of reducing autism symptoms.
The agency is restoring the approval of Wellcovorin, the branded version of leucovorin made by GlaxoSmithKline that the company stopped selling in 1999.
“We have a duty to let doctors in the public know. We are going to change the label to make it available. Hundreds of thousands of kids will benefit,” said Makary.
The Society for Maternal-Fetal Medicine (SMFM) pushed back on the White House’s announcement.
“Despite assertions to the contrary, a thorough review of existing research suggesting a potential link between acetaminophen use during pregnancy and an increased risk of autism and attention deficit and hyperactivity disorder (ADHD) in children has not established a causal relationship,” the SMFM said in a statement.
The organization said it “supports continued research that includes pregnant patients to understand the potential causes of neurodevelopmental disabilities in children.”
Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), said the announcement on Monday was “irresponsible” and could send a “harmful and confusing message” to pregnant patients.
“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,” Fleischman said.
Trump was asked about ACOG’s opposition during the briefing.
“They’re funded by lots of different groups. And you know what? Maybe they’re right,” Trump responded. “I don’t think they are, because I don’t think the facts bear it out at all. They’re fighting for something that, in my opinion, they shouldn’t be fighting for”
The Coalition of Autism Scientists said it “strongly opposes” both the promotion of a link between acetaminophen and autism as well as recommending leucovorin.
“There are only a handful of clinical trials of leucovorin and evidence connecting treatment to improvements in outcomes is very weak,” said the group. “All of them are very small, and the study designs and approaches to statistical analyses of the data are not all of high quality. It is premature to claim that leucovorin is an effective treatment for autism and add autism as a secondary indication.”
Updated 7:14 p.m.
