Dr. Mehmet Oz told CBS News chief Washington correspondent Major Garrett on “The Takeout” Thursday the Trump administration is not advising pregnant women to avoid taking Tylenol under any circumstances — as President Trump’s announcement this week about an alleged link between the painkiller and fever reducer and autism draws pushback from medical experts.
Oz — a former surgeon and television personality who leads the Centers for Medicare and Medicaid Services, an agency that is under the Department of Health and Human Services — said that if a pregnant woman develops a high fever, a doctor will likely encourage her to take acetaminophen, the active ingredient in Tylenol, because fevers can pose health risks. And studies show acetaminophen is the safest medication to treat fevers in pregnant women.
“The concern here is that I believe most women get low-grade fevers, they stub their toe, they have little aches and pains, and they think it’s perfectly safe to throw a couple paracetamol or acetaminophen or Tylenol when they’re pregnant, and I don’t think that’s the case,” Oz said.
On Monday, Food and Drug Administration Commissioner Marty Makary released an open letter to physicians that said acetaminophen use during pregnancy “may be associated with” an increased risk of conditions like autism.
The letter noted that “while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established.”
Makary’s letter was also more tempered than Mr. Trump’s comments during a news conference earlier this week in which the president said there’s “no downside in not taking” Tylenol.
“Acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics,” Makary wrote in his letter.
There is concern among the medical community that, as a result of the FDA’s announcement Monday, that some patients could turn to other pain medications that are proven to be unsafe during pregnancy.
“You should not, under any circumstances, avoid taking acetaminophen if you have a fever early in pregnancy, if you have a headache, if you have some other condition in pregnancy, we want you to take that medication,” Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told CBS News following the FDA’s announcement. “The overwhelming evidence that we have seen over the last 20 years does not show causation for acetaminophen causing autism.”
In a statement in response to the FDA’s announcement, Kenvue, the maker of Tylenol, said, “Independent, sound science clearly shows that taking acetaminophen does not cause autism,” calling it “the safest pain reliever option for pregnant women as needed throughout their entire pregnancy.”
Oz also addressed Makary’s announcement that the agency will approve the prescription drug leucovorin, which is derived from folic acid, to treat autism in children. Specialists say leucovorin can be helpful in treating some autism cases, but it is not a universal remedy.
“The key question is, if you, as a researcher on those trials, had a child, would you give that child leucovorin?” Oz said he asked of researchers studying leucovorin. “And when I asked the doctors on those trials, they said yes.”
Autism has become more prevalent in children born in the U.S. over the past 25 years, according to data from the U.S. Centers for Disease Control and Prevention, but there is no scientific consensus as to why.
Oz said that when he, Makary and Jay Bhattacharya, director of the National Institutes of Health, were asked by the White House to examine the issue, they found two “clues,” not conclusions, that pointed to leucovorin as a possible treatment option for autistic children, and acetaminophen as a medication pregnant women should be cautious about taking.
“These are things that we believe, that if you’re fully transparent about, you’ll rebuild trust with the American people,” Oz said. “Just tell people what you know.”
Oz argued that Mr. Trump was right in pushing for the FDA to both approve leucovorin and make its Tylenol recommendation — even though there is no consensus in the medical community and no definitive evidence supporting either move — because he believes the FDA has an obligation to be transparent.
But Oz was clear that patients should consult their doctors first before making a decision.
“The Tylenol issue is whether or not we should warn moms, who are pregnant today, about a problem that we may not know fully the answer to — ‘Is Tylenol a problem during pregnancy?’ — for another five years,” Oz said. “Well, what about the kid today? Are you going to take the Tylenol or not. Well I think the answer is, the best prudent answer, of course take it if a doctor says you need it. But don’t take it on your own without thinking twice about it.”
Oz also indicated that he would not advise a pregnant family member to take Tylenol without talking to their physician first.
“We’re guarded in saying we don’t have all the answers,” he said. “But if it’s my family, I’m not going to have my pregnant daughter take acetaminophen if she doesn’t need to be on it without certainly talking to a doctor about it.”
Sara Moniuszko and
Dr. Céline Gounder
contributed to this report.
