What pregnant people should know about acetaminophen
By Deidre McPhillips, CNN
(CNN) — Pregnant people should not be afraid to take Tylenol, experts say, rebuking unproven claims made by the Trump administration that it can cause autism.
At a news briefing Monday, President Donald Trump repeatedly issued a broad warning: “If you’re pregnant, don’t take Tylenol. When you have your baby, don’t give your baby Tylenol at all unless it’s absolutely necessary.”
But years of research have led major medical organizations in the United States to support the use of acetaminophen, or Tylenol, to treat pain and fever during pregnancy, with recommendations reflecting that the benefits outweigh any potential risks.
“Today’s White House event on autism was filled with dangerous claims and misleading information that sends a confusing message to parents and expecting parents and does a disservice to autistic individuals,” Dr. Susan Kressly, president of the American Academy of Pediatrics, said in a statement.
There are significant limitations to the conclusions that can be drawn from the research on the link between Tylenol and autism, experts say, and no new research was presented at Monday’s briefing. Acetaminophen is still widely considered among the best and safest options to treat pain and fever during pregnancy.
The American College of Obstetricians and Gynecologists says that acetaminophen is safe to use during pregnancy and recommends it as a first-line treatment – and the group confirmed Monday that it does not plan to change that guidance.
The Society for Maternal-Fetal Medicine also reaffirmed its guidance that acetaminophen is an “appropriate medication to treat pain and fever during pregnancy.”
Pregnant patients should discuss any medication use during pregnancy with their provider, the organization says, but “the weight of evidence is inconclusive regarding a possible causal relationship between acetaminophen use and neurobehavioral disorders in the offspring.”
The body of research exploring the link between autism and acetaminophen use during pregnancy is not conclusive, and there’s even less research looking at autism prevalence relative to acetaminophen use during infancy or early childhood.
Excessive use of acetaminophen poses serious risks to infants and children, so parents should consult dosing guidelines carefully and check with their pediatricians before use. But the identified risks are related to liver damage, not autism.
“The most important thing that was said during that conference today is that autism is complex with a multi-factorial etiology, and that is the truth,” Dr. James McPartland, a child psychologist and director of the Yale Developmental Disabilities Clinic, told CNN. “What that means is that autism is complicated, and there’s not one cause.”
Risks vs. benefits
Earlier this year, researchers from the University of South Florida and the University of British Columbia compiled a review of studies on the most commonly used pain medications during pregnancy and the potential risk to the fetus.
Some drugs have been found to carry risk. Using the steroid prednisone during pregnancy, for example, may cause a cleft lip or palate birth defect. Ibuprofen such as Advil and other nonsteroidal anti-inflammatory drugs, or NSAIDs, should only be used in the second trimester, according to ACOG guidance. Research suggests that taking ibuprofen during the first trimester can cause miscarriage and has been linked to multiple birth defects. Some links to birth defects were also found when taken during the third trimester.
Trump said Monday that there is “no downside” to not taking Tylenol during pregnancy, but it is widely understood that leaving pain or a fever untreated during pregnancy also carries serious risk.
A research review published in the journal Pediatrics found that a fever during the first trimester could be especially dangerous, raising the risk of congenital heart defects, neural tube defects and oral clefts by up to three times.
Fever during pregnancy – especially high-grade fevers – can affect the fetus’ brain development, and some studies have identified the fever itself as a risk factor for neurodevelopment disorders such as autism.
Experts say that much more research is needed on the topic, and there is also some evidence that taking medicine to reduce fever could have a protective effect.
Some people may want to avoid medication during pregnancy as much as possible, and many may opt to manage through a mild headache or other pain without taking anything, said Dr. Allison Bryant, an ob/gyn and maternal-fetal medicine specialist with Massachusetts General Hospital.
But sometimes, providers might advise pregnant patients to take acetaminophen so they can be sure the pain can be treated and doesn’t signify a more serious underlying condition, she said.
“If someone has a headache in pregnancy, we oftentimes want to know that that headache will go away,” Bryant said. “We sometimes use acetaminophen in a diagnostic way to know that it’s not a headache associated with high blood pressure. So we want people not to be afraid to use it in those contexts when it’s recommended.”
The best of limited options
At Monday’s briefing, health officials announced that the US Food and Drug Administration will issue a notice to physicians “about the risk of acetaminophen during pregnancy” and work to change the safety label on products like Tylenol.
The US Department of Health and Human Services will advise clinicians to “prescribe the lowest effective dose for the shortest necessary duration and only when treatment is required,” Secretary Robert F. Kennedy Jr. said.
This is generally in line with existing guidance from medical organizations.
“Existing guidance suggested to use Tylenol – and any drug – during pregnancy as sparingly as possible. So what was discussed today is actually very, very much in alignment with what’s existed for a long time,” McPartland said. “Pregnant women should be consulting with their obstetricians to determine what’s appropriate for them given the risk factor associated with being ill during pregnancy.”
Nuanced conversations are important because recommendations for treating pain or fever in a pregnant patient will be different than they are for people who are not pregnant, said Bryant, who also leads ACOG’s clinical consensus committee on obstetrics.
“The options are pretty limited, and the risk can be real,” she said.
Experts broadly agree that acetaminophen is one of the best options to manage pain and fever during pregnancy – it’s an easily accessible over-the-counter drug that most pregnant people report using.
Decades of research from large and case-control studies have found acetaminophen to be “generally safe” when taken as recommended during pregnancy, the recent review of studies found.
But more recent work that has focused potential links between acetaminophen use during pregnancy and neurodevelopmental outcomes including autism “suffer from serious biases,” the researchers said.
The Society for Maternal-Fetal Medicine reviewed these studies before publishing its current guidance and also found significant limitations. Many studies are based on self-reported use of acetaminophen without details on size of the dose or duration of use. Some also rely on self-report of a neurodevelopmental disorder in the child without clinical confirmation.
The question then becomes whether acetaminophen itself is linked to autism or if the underlying pain or fever that led the pregnant person to take acetaminophen is the stronger link, Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told CNN on Monday.
“In these trials where you’re looking back on things, you don’t really get that clear causality relationship,” Fleischman said. “I think it’s really premature to go out and say we found a cure, because even in the one or two studies that suggest a relationship, that relationship is very small and really, I would say, poorly designed studies that came to those results.”
Communication is key
Guidance from the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and others are meant to serve as evidence-based resources to support informed conversations between providers and their patients.
“As with all medication use during pregnancy, communication regarding the risks versus the benefits of prescription and over-the-counter medications use should occur between patient and provider,” the Society for Maternal-Fetal Medicine’s publication committee says in a statement.
It’s common for pregnant people to feel a lot of pressure to do things just right, and that stress can be a lot to handle, said Dr. Elizabeth Werner, a clinical psychologist with Columbia University who specializes in working with people during pregnancy and postpartum. Clinical studies involving pregnant people provide loose associations more often than causal links, she said, and that uncertainty can raise confusion and anxiety.
“You’re trying to make sure that you’re doing the best that you can during your pregnancy, so it can be very stressful when you don’t know what it is you’re actually supposed to be doing or not supposed to be doing,” she said.
Considering the sources of information becomes really important.
“I really recommend that people speak with their doctor and parse through information along with a doctor who knows the specifics of their life and their situation so they can make an educated decision about how best to proceed with something like medical treatment that they may need,” Werner said.
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