Medical experts are pushing back against President Donald Trump’s unproven claim linking the use of common pain reliever Tylenol during pregnancy to autism in children, expressing concern that fear of the drug could prompt expectant mothers to skip treating fevers, a known risk factor for birth defects.
During a White House event on Monday, Trump repeatedly instructed pregnant women to stop taking the over-the-counter medication.
“Don’t take Tylenol. Don’t take it. …Fight like hell not to take it,” Trump said during the event. He also advised expectant mothers to “tough it out” if they experience pain or fever, claiming that there was “no downside” to avoiding the drug.
Following Trump’s comments, obstetrician-gynecologists in Columbus and elsewhere in Indiana have reported a noticeable increase in patients asking about the link between the drug and autism.
Tylenol is an over-the-counter pain reliever and fever reducer. Its active ingredient is acetaminophen, according to the Mayo Clinic.
“Research has not found a causal relationship between acetaminophen use and autism,” said Dr. Jasmine Johnson, an assistant professor of obstetrics and gynecology in the division of maternal-fetal medicine at the Indiana University School of Medicine. “…(Research) has been consistent to show that acetaminophen use and pregnancy does not cause autism. And the Society of Maternal-Fetal Medicine, the American College of Obstetrics and Gynecology and the American Academy of Pediatrics all affirmed this as well.”
Medical experts say acetaminophen has been and continues to be the standard of care for treating fever, headaches and general pain during pregnancy, though they stressed it should always be taken in moderation and after discussion with a doctor.
“(Acetaminophen) is still considered the standard of care when used in moderation and for clinically appropriate reasons in pregnancy,” said Dr. Brendan Barker, an obstetrician-gynecologist at OB/GYN Associates in Columbus. “The problem is that in pregnancy, untreated fever or untreated headaches can have detrimental effects.”
There can be downsides to avoiding Tylenol when a pregnant woman really needs it, according to medical experts. Untreated fevers can increase the risk of birth defects, premature birth and miscarriages, according to the Society for Maternal-Fetal Medicine.
“My concern would be that pregnant patients wouldn’t have these discussions with their obstetrician-gynecologists where we can kind of dive into the research and evidence behind each of these studies, and they would just at face value stop utilizing these medications, and we could start to potentially see downstream negative effects,” Barker said.
Trump’s comments came during a White House event in which his administration announced a wide-ranging effort to study the causes of autism.
Autism spectrum disorder is a condition that affects how people perceive and interact with others, often leading to challenges in communication and social relationships, according to the Mayo Clinic. It is not an illness or disease. The word “spectrum” refers to the wide variation in symptoms and their severity.
Decades of research indicate that there is no single root cause of autism, according to the Cleveland Clinic. Because the condition is complex and symptoms vary, researchers believe multiple factors may be involved, including genetics and environmental factors.
While the number of children diagnosed with autism spectrum disorder is climbing, researchers say the increase could be due to more effective ways to identify and report cases, an actual rise in the condition’s occurrence or a mixture of the two, according to the Mayo Clinic.
In 2000, the Centers for Disease Control and Prevention put the diagnosis rate at 1 in 150. In 2018, it was 1 in 44. The latest count, based on 2022 data, is 1 in 31.
Scientists say the explanation is that decades ago diagnosis was rare, given only to kids with severe problems, The Associated Press reported. Diagnosis of “autism spectrum disorder” began jumping as scientists learned the developmental disorder encompasses a wide range of traits and symptoms. And as educational and other services grew, more parents began seeking diagnoses to help their kids.
On Monday, the U.S. Food and Drug Administration also said it will add a warning label to acetaminophen, citing a “possible association” between autism and acetaminophen use during pregnancy. However, regulators didn’t go as far Trump in a letter to doctors this week that instead they “should consider minimizing” acetaminophen’s use in pregnancy.
“It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the FDA said in a statement on Monday in which it announced the label change. “It is also noted that acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children. Additionally, aspirin and ibuprofen have well-documented adverse impacts on the fetus.”
Some studies have raised the possibility of a link between autism risk and using acetaminophen during pregnancy — but more haven’t found a connection, according to wire reports.
These are observational studies that compare health records about prenatal acetaminophen and autism traits in children, according to wire reports. However, those kinds of studies can’t tell if the painkiller really made any difference – or if instead it was the fever or other health problem that prompted the need for the pill.
The Coalition of Autism Scientists notes that use of during pregnancy hasn’t increased in recent decades like autism rates have.
For its part, New Jersey-based Kenvue Inc., the maker of Tylenol, rejected Trump’s comments, telling The Republic in a statement that, “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 about the health risks and confusion this poses for expecting mothers and parents.”
Several major medical organizations and scientific groups also pushed back against Trump’s comments, including the American College of Obstetricians and Gynecologists, American Academy of Pediatrics and the Society for Maternal-Fetal Medicine.
“Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children,” American College of Obstetricians and Gynecologists President Dr. Steven J. Fleischman in a statement. “It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data. 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.”
The American Academy of Pediatrics, which does what, also issued a statement on Monday, noting that studies have found no evidence that taking acetaminophen during pregnancy causes autism.
“Decades of research have found that acetaminophen is safe for children when administered as recommended,” according to the AAP. “Misleading claims that the medicine is not safe and is linked to increased rates of autism send a confusing, dangerous message to parents and expectant parents and does a disservice to autistic individuals. …Research does not show a causal link between acetaminophen use in children and autism. Similarly, studies have found no significant or confirmed associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD or intellectual disability.”
The Society for Maternal-Fetal Medicine also reiterated its recommendation that “acetaminophen is an appropriate medication to treat pain and fever during pregnancy.”
“In response to today’s White House press conference announcement, the Society for Maternal-Fetal Medicine reiterates its recommendation advising both physicians and patients that acetaminophen is an appropriate medication to treat pain and fever during pregnancy,” the Society for Maternal-Fetal Medicine said in a statement. “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.”
Barker said “just like any medication in pregnancy, (Tylenol use during pregnancy) should a consideration of benefits versus risk” and after discussion options with a doctor.
“(Tylenol) has been studied in pregnancy for multiple decades,” Barker said. “This is not a new medication that recently hit the market. It’s been studied extensively both in pregnancy and outside of pregnancy for multiple decades. …Tylenol is certainly considered safe in pregnancy when take as needed, in moderation and certainly after consultation with your physician.”
