Many doctors and public health officials are taking issue with President Trump’s claim that there’s “no downside” to avoiding acetaminophen during pregnancy and his suggestion that expecting mothers should “tough it out” when it comes to fevers.
Acetaminophen, the active ingredient in Tylenol and many cold and flu medications, is used to reduce pain and fever in pregnancy.
“Don’t take it. There’s no downside in not taking it,” Mr. Trump said during an announcement Monday that linked the use of the drug during pregnancy to an increased risk of autism in children without giving new evidence and ignoring data that shows there is not a causal relation.
The Food and Drug Administration is “strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” he said. “That’s, for instance, in cases of extremely high fever that you feel you can’t tough it out, you can’t do it. I guess there’s that. It’s a small number of cases, I think. But if you can’t tough it out, if you can’t do it, that’s what you’re going to have to do. You’ll take a Tylenol.”
In an open letter to physicians released after Mr. Trump’s announcement, FDA Commissioner Marty Makary was more cautious than the president, writing, “clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.”
But doctors worry the suggestion to “tough it out” will harm women and their babies, as high fever and pain can be dangerous during pregnancy.
“The messaging of ‘tough it out’ is something that unfortunately we have said to women in health care in this country for far too long,” Dr. Lucky Sekhon, an OB/GYN and infertility specialist in New York City, told CBS News.
There’s also a concern patients may turn to other pain medications that are proven to be unsafe during pregnancy. Makary noted in his letter that “acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics.” (Antipyretics are drugs that reduce fever.)
In a statement, 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.”
“Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives,” the company said.
The risks of fever during pregnancy
Medical experts warn that fevers during pregnancy can cause problems for a developing baby.
Especially in early pregnancy, fevers are associated with cardiac issues, cleft lip, cleft palate and central nervous system abnormalities, Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told CBS News after Mr. Trump’s announcement.
“The idea that we’re going to let someone with a fever ‘tough it out’ may have much worse implications for a pregnant woman than taking a dose of acetaminophen to bring that fever down,” he said. “I think that’s not really an appropriate way to handle medical issues in pregnancy.”
Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, echoed it’s important to not let fevers go untreated due to the risk of brain development issues in the baby.
“Fever and infections during pregnancy can cause neurodevelopmental disorders including potentially autism,” she said. “I worry that this will scare women and that pregnant women may avoid Tylenol even when it’s entirely appropriate, for example, to treat a fever.”
Internal medicine physician Dr. Shoshana Ungerleider said science does not support the administration’s claims.
“What’s far riskier is leaving a fever untreated during pregnancy which can harm both mom and baby, so Tylenol remains the safest option we have in those situations,” she said.
Why Tylenol or acetaminophen is advised
Gounder said she’s concerned that expectant mothers with a fever or pain may turn to other options that would be less safe.
“Will women end up taking other medications like aspirin or ibuprofen during pregnancy? Those actually can be dangerous, especially in the third trimester, you can end up with kidney issues, cardiac issues in the baby,” she said.
Fleischman agreed that acetaminophen is the safest option.
“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,” he told CBS News. “The overwhelming evidence that we have seen over the last 20 years does not show causation for acetaminophen causing autism.”
That research, he explained, includes a large study published last year which analyzed data on 2.5 million pregnancies and found no increased risk of autism in children whose mothers took acetaminophen.
The lead author of that study, Viktor H. Ahlqvist, PhD, of the Karolinska Institutet in Sweden, said in an interview that acetaminophen continues to be “the recommended option” for use during pregnancy.
He shared the concern that “alternatives to acetaminophen in the U.S. might be other medications with less-safe profiles, such as opioids or other things to manage pain. We do know that these have serious consequences when used in pregnancy, both for the mom and for the baby.”
These doctors are not alone. Health experts from around the world have pushed back against the Trump administration’s claims about acetaminophen and autism.
The European Union’s European Medicines Agency said Tuesday there is “no new evidence” that would require changes to the current recommendations for use of acetaminophen, also called paracetamol outside the U.S.
“Paracetamol remains an important option to treat pain or fever in pregnant women,” Steffen Thirstrup, EMA’s chief medical officer, said in the statement. “Our advice is based on a rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.”
What should pregnant women do?
Pregnant patients should consult with their doctor on what’s the best for them, but Fleischman pointed out that acetaminophen is only used when necessary.
“You don’t take Tylenol just for fun. … It’s not like a [daily] vitamin, and we would never treat it that way,” he said. “Patients are told to use acetaminophen when they have a fever, when they have a headache or other pain symptoms in pregnancy which require treatment.”
The medication is generally recommended for a fever above 100.4, Fleischman explained.
“We know that higher fevers are definitely associated with more issues but if your temperature is above 100.4, taking acetaminophen to bring that down is definitely advised,” he said.
A single extra-strength dose, which is 500 mg, should be “more than adequate,” he added, but said it can be repeated if needed.
“As always, we want our patients to consult with their health care provider before using any medications, but all of the data shows that it’s safe and there is no data that shows Tylenol causes autism,” Dr. Veronica Gillispie-Bell, a board-certified obstetrician-gynecologist, told CBS News.
She shared concerns over the FDA initiating a label change on Tylenol and acetaminophen to warn of a possible association with autism.
“I think it will make our moms scared to take Tylenol, and the repercussions, again, for those moms that are having fever and those moms that are having pain, those repercussions can be very detrimental. And it’s really shameful when we know that Tylenol is safe and again we have no studies showing that it causes autism,” Gillispie-Bell said.
contributed to this report.
