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Tag: acetaminophen

  • Texas attorney general sues Tylenol makers, claiming links to autism

    (CNN) — Texas Attorney General Ken Paxton has filed a lawsuit against the companies Johnson & Johnson and Kenvue, claiming that they “deceptively” marketed Tylenol to pregnant mothers and that the medication is tied to an increased risk of autism. Kenvue said in a statement that the medication is safe and the company will “vigorously defend” against the claims.

    The lawsuit, dated Monday and filed in the District Court of Panola County, Texas, comes about a month after President Donald Trump publicly claimed that the use of Tylenol during pregnancy can be associated with an increased risk of autism in the child, despite decades of evidence that the medication is safe.

    “Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks. These corporations lied for decades, knowingly endangering millions to line their pockets,” Paxton, the state’s Republican attorney general, who is also running for US Senate, said in a news release Tuesday. “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”

    The lawsuit claims that Johnson & Johnson and Kenvue violated the Texas Deceptive Trade Practices-Consumer Protection Act because they knew that acetaminophen, the active ingredient in Tylenol, “is dangerous to unborn children and young children” and “they hid this danger and deceptively marketed Tylenol as the only safe painkiller for pregnant women,” according to the lawsuit.

    The state’s lawsuit has requested a jury trial and, in part, calls for the companies to “destroy any marketing or advertising materials in their possession that represent, directly or indirectly, that Tylenol is safe for pregnant women and children.” The lawsuit also calls for the companies to pay civil penalties to the state in the amount of $10,000 per violation.

    “Nothing is more important to us than the health and safety of the people who use our products. We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children,” Kenvue said in an emailed statement Tuesday.

    “We will vigorously defend ourselves against these claims and respond per the legal process. We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support,” the statement said in part. “We also encourage expecting mothers to speak to their health professional before taking any over-the-counter medication, including acetaminophen, as indicated on our product label for Tylenol®.”

    In a statement, a Johnson & Johnson company spokesperson said it “divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

    Texas Attorney General Ken Paxton filed a lawsuit that says makers of Tylenol “deceptively marketed” the medication as the “only safe painkiller for pregnant women.” Credit: Mandel Ngan/AFP / Getty Images via CNN Newsource

    Experts have said there are multiple causes of autism, and the science showing a connection between autism and Tylenol is not settled.

    “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement in September.

    “Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated. Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it,” he said. “The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.”

    Jacqueline Howard and CNN

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  • Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism

    (CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children.

    Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and that “adoption of the proposed labeling revisions would be arbitrary, capricious, and contrary to law.”

    Tylenol generates $1 billion annually for the company and is considered the company’s biggest-selling brand, according to the brokerage Morningstar.

    The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”

    The push for a label change came after President Donald Trump held a news conference last month in which he told pregnant women who are in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is the one over-the-counter pain reliever considered safe for pregnant people to take.

    The president claimed without evidence that Tylenol use during pregnancy was linked to a “very increased risk of autism.”

    “Fight like hell not to take it,” Trump urged.

    Most people use acetaminophen at some point during their pregnancy, studies show. Other common pain or fever treatments like ibuprofen or regular-dose aspirin can increase the risk of serious complications when used during pregnancy.

    Untreated pain or fever can be dangerous for the mother and the fetus, possibly leading to problems like miscarriage, birth defects or high blood pressure.

    Beginning the process to change the safety label on acetaminophen products was just one action the Trump administration planned to take.

    US Health and Human Services Secretary Robert F. Kennedy Jr. said at the news conference last month that his agency would launch a public service campaign about the issue.

    The FDA also sent a letter to physicians saying that the choice to take Tylenol “still belongs with parents” but that use during pregnancy may cause an “increased risk of neurological conditions such as autism and ADHD in children.”

    However, the letter also noted that “a causal relationship has not been established” and that studies about a link are “contradictory.”

    The Informed Consent Action Network, an anti-vaccine nonprofit with close ties Kennedy, said in a letter dated the day of Trump’s news conference that it had filed a citizen’s petition with the FDA. Such filings are a way for individuals, industry or consumer groups to ask the agency to take action on a specific issue.

    The petition says that because of the “urgent public health implications,” the FDA should act quickly to add a more detailed warning to the labels of over-the-counter drug products that contain acetaminophen to spell out that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder.”

    On Friday, Kenvue asked the FDA to deny the petition, saying that suggested changes to the label are unsupported by scientific evidence “and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy.”

    The company said it met with Kennedy in early September, after the HHS secretary reached out to say he believed there was a connection between acetaminophen use during pregnancy and autism, and it told him there was no such link.

    An HHS spokesperson said Monday that the FDA doesn’t comment on product-specific matters.

    The FDA website on acetaminophen has not changed to reflect the Trump administration’s views. It says it was last updated in August and specifies, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”

    Acetaminophen has been studied for decades to find any problems it may cause in pregnancy, according to the American College of Obstetricians & Gynecologists. Not one reputable study has concluded that acetaminophen use in any trimester of pregnancy causes neurodevelopmental disorders in children.

    That group points to a study published last year of more than 2 million children that found no significant associations between acetaminophen use during pregnancy and children’s risk of autism, ADHD or intellectual disability.

    Another study published in August analyzed 46 studies on acetaminophen use during pregnancy and neurodevelopmental disorders. Six of the studies specifically examined acetaminophen use and autism. Overall, the analysis concluded that there was “strong evidence of an association” between acetaminophen use during pregnancy and autism, but the authors were careful to say that the paper could only show an association, the research could not show that acetaminophen caused autism.

    “We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote in that analysis.

    After the Trump news conference, medicine regulatory agencies for the European Union and the United Kingdom and Health Canada quickly issued statements confirming that taking the over-the-counter pain-reliever during pregnancy remains safe.

    Jen Christensen and CNN

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  • Does circumcision lead to autism? No study shows that

    Circumcision doesn’t typically come up at White House Cabinet meetings, but Health and Human Services Secretary Robert F. Kennedy Jr. recently brought up the procedure in the context of autism.

    “There’s two studies that show children who are circumcised early have double the rate of autism, and it’s highly likely because they’re given Tylenol,” said Kennedy, who like President Donald Trump cited shaky research about the drug and autism when warning pregnant women against taking Tylenol. 

    Circumcision is the removal of penis foreskin, a typically elective procedure performed on infants largely for religious and cultural reasons.

    We looked at the studies, one from 2013 and one from 2015. 

    Neither showed that circumcision causes autism. Neither had data on whether acetaminophen, the active ingredient in Tylenol, was given to the patients in the studies.

     The two papers found some association between circumcision and autism, but both had significant limitations, including small sample sizes.

    Authors of both papers advised further research would be needed to confirm a relationship.

    Decades of research shows that acetaminophen is safe for infants and children when used as recommended and under a pediatrician’s guidance. No research shows taking acetaminophen as a child causes increased autism risk.

    Acetaminophen is not universally recommended for circumcisions. Infant circumcision is typically performed with a local anesthetic. Some hospital guidelines advise parents that they can give infants acetaminophen as needed for pain in the days following the procedure. 

    Asked about Kennedy’s statements on circumcision, a Health and Human Services Department spokesperson pointed us to the secretary’s Oct. 10 X post in which he pointed to the 2015 study and an unpublished research paper from 2025. 

    Unpublished article is not new research, a review of existing studies

    The 2025 paper Kennedy referenced in his X post has not been peer-reviewed. It’s considered a pre-print, which means it hasn’t been vetted by other scientific experts in the field, a standard process for scholarly research that aims to ensure its quality and rigor prior to publication. The paper was authored by researchers at WPLab, a North Carolina company that promotes a link between acetaminophen and autism. In September, The Atlantic reported that WPLab CEO William Parker, a retired Duke University associate professor, has been in frequent contact with Kennedy. 

    The WPLab paper starts by saying in its abstract that “overwhelming evidence” shows acetaminophen exposure in babies “triggers many if not most cases of autism spectrum disorder.” The company makes similar statements about causation in several other papers, but that view does not reflect scientific consensus. 

    The premise of the article posted this summer is that “evidence that acetaminophen triggers autism” has been “ignored and mishandled” in existing published research. It is a critique and analysis; it doesn’t represent any new scientific research. It points to the 2013 and 2015 studies about circumcision and autism, but misrepresents the scope of the 2015 study’s findings. It does not explain that the 2013 study was a basic population-level look at circumcision rates and autism rates. 

    2013 study was a ‘hypothesis generating’ exercise that compared circumcision rates with autism rates

    Authored by UMass-Lowell epidemiologists, the 2013 peer-reviewed study aimed to see if there was an association (not causation) between giving young infants acetaminophen and developing autism. The study was described by the authors as a “hypothesis generating exploratory analysis,” meaning it wasn’t intended to reach a final conclusion about a link.

    Circumcision was not the focus. Data about the procedure was analyzed as if it were a proxy for giving Tylenol to a baby. But the study did not confirm whether the drug was given in the cases it cited. 

    The study looked at nine countries. For each country, it collected two pieces of data — the percentage of the population that was circumcised and its prevalence of autism in men. In some cases, the circumcision rate was estimated based on the number of Jewish and Muslim men in a country.

    It used those few pieces of data to calculate a correlation. 

    “You can’t really do a correlation with any level of legitimacy from a statistical point of view on such a small sample size,” said Helen Tager-Flusberg, professor emerita at Boston University and founder of the Coalition of Autism Scientists. 

    The study said there was a positive association between a population’s circumcision rates and its autism rates, but cautioned there were “significant limitations” to the study and that “correlation is not causation and as such no causal inference is intended.” The authors called for more research to “confirm or disprove this association.” 

    Despite having no data on whether kids represented in the data were given acetaminophen, the study linked the finding to the drug’s use by looking at data from before 1995, around the time when acetaminophen became a tested treatment for circumcision-related pain. The study found a slightly weaker correlation pre-1995.

    2015 study was in Denmark where circumcision is rare, didn’t assess acetaminophen use 

    The 2015 Danish study explored whether being circumcised meant a boy was more likely to be diagnosed with autism before age 10. The study did not examine acetaminophen use.

    The study found that the risk of autism was 46 to 62% increased in boys who were circumcised, but this finding needs a lot of context. 

    First, circumcision in Denmark is rare and happens mostly among Jewish and Muslim families. But the study had only circumcision data from hospitals and doctor’s offices, meaning it didn’t count procedures that happened in home religious ceremonies.

    Additionally, because circumcision and autism diagnoses are both uncommon, those groups’ sample sizes were small. In a study of 342,877 boys born between 1994 and 2003, fewer than 1% (3,347 boys) were circumcised and around 1.5% (5,033 boys) had autism. Just 57 boys had both. 

    “We’re talking about a relatively small number of children out of this very large Danish population,” Tager-Flusberg said. When the study broke the samples down by faith groups, or eliminated incomplete data from the analysis, its findings were more dramatic but based on even smaller numbers. The 62% increased risk of autism finding was based on just 24 boys. Other researchers in the field publicly criticized the study for issues with its methods.

    In 2019, one of the study’s authors, Morten Frisch proposed that the Danish Parliament should prohibit circumcision until the age 18.  

    Although the 2015 study did not look at acetaminophen use, the WPLab paper cited it as “some of the most compelling ‘standalone’ evidence that acetaminophen triggers autism in susceptible babies and children” — a statement Kennedy quoted from in his X post. 

    “Neither of these studies take into consideration a whole range of potential cultural demographic or other confounding variables that one must always be aware of when looking at associations between some sort of risk factor and autism,” Tager-Flusberg said.

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  • Read labels, ask doctors: How to give Tylenol to your child

    It isn’t often that President Donald Trump issues parenting advice. But in late-September, he repeatedly warned parents to stop giving Tylenol to young children. 

    “When you have your baby, don’t give your baby Tylenol at all unless it’s absolutely necessary,” he said during a Sept. 22 press conference focused on the administration’s actions to address increasing autism diagnoses.

    Trump’s recommendation is at odds with medical research, pediatric advice and U.S. public health guidance. During the same Sept. 22 remarks, Trump told pregnant mothers to avoid taking Tylenol because of what he described as a risk that its active ingredient acetaminophen could cause autism in their children. That’s scientifically unproven, and there’s no proof of a connection between childhood acetaminophen use and autism either.

    Trump’s statements may leave parents newly uncertain about how to respond when their children have fevers or pain. Pediatricians told us that Tylenol is safe for children when taken as directed. Parents should always read medicine labels, consult their doctors and take measures to make sure they are administering acetaminophen as indicated and in its appropriate doses. 

    Here are answers to some basic questions: 

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    What is acetaminophen?

    Acetaminophen is widely used to reduce pain and fever. It is an active ingredient in some brand-name over-the-counter medications including Tylenol, Dayquil, Dimetapp, Robitussin and Sudafed. It has some risks, and those risks have made headlines: Too much acetaminophen can cause overdose and severe liver damage.

    Acetaminophen does not reduce inflammation, unlike over-the-counter pain relievers such as ibuprofen, which is found in Advil and Motrin, and naproxen, found in Aleve. Those inflammation reducers are known as nonsteroidal anti-inflammatory drugs, often referred to as NSAIDs.

    What do doctors say about acetaminophen’s safety?

    Acetaminophen is safe, doctors say, when taken as recommended and under a pediatrician’s guidance. This finding is supported by decades of research. 

    Soon after Trump’s statements, the American Academy of Pediatrics affirmed acetaminophen’s safety when taken as directed and turned to social media to get the word out. “There is no causal link between acetaminophen and autism,” it wrote on Facebook. 

    Pediatricians echo that message.

    Babies under 3 months old have immature immune systems, so parents should talk to their doctors before administering any medication, UC Davis Health’s Children’s Hospital pediatrician Dr. Lena van der List said. Once babies reach 3 months, parents should be able to give them acetaminophen for moderate pain and to reduce fevers of 100.4 F or higher. 

    “Used with proper guidance and for the correct indications, Tylenol has a place in routine pediatric care,” said Dr. Flor Muñoz, Baylor College of Medicine associate professor of pediatrics and infectious diseases.

    How can I make sure I am giving Tylenol appropriately to my child?

    Read ingredient labels on over-the-counter medications. Don’t combine medications that, taken together, exceed the appropriate doses of acetaminophen. Measure medicine using marked medicine cups or syringes. When giving acetaminophen orally, don’t give more than four doses in 24 hours. 

    Even in adults, using multiple acetaminophen-containing products such as cough medicine, menstrual relief medication or headache medicine can lead to overdoses, Rand said. 

    “It’s a great idea to keep a log of the date and times the medication was administered,” van der List said.

    How do I decide if acetaminophen is the right call? 

    Evaluate how sick your child looks, feels and behaves. 

    “If your child has a fever but is still able to sleep, drink fluids to stay hydrated and is generally comfortable — then it’s O.K. to forgo fever-reducing medications, such as acetaminophen,” van der List said. 

    Children should see a doctor for any fever that persists for five days. If you don’t have a clear reason for administering the medication, avoid giving it to a child over a longer period. 

    “If it’s a fever, great, that’s an appropriate use for acetaminophen,” van der List said. “If it’s vague symptoms, like your infant waking up nightly crying for weeks that you have attributed to ‘teething pain,’ this may be a time to check in with your health care provider as there may be something aside from pain contributing.”

    Has the federal government changed its guidance on acetaminophen’s safety for children? 

    Official public health communications remained the same as before Trump’s comments, as of Oct. 3. The U.S. Food and Drug Administration describes acetaminophen as “safe and effective when used as directed.” Health officials from the FDA and Health and Human Services Department have not announced actions related to childhood acetaminophen use. 

    Medline Plus, a website that is part of the National Institutes of Health’s National Library of Medicine and that provides advertising-free health information, echoes the FDA when describing acetaminophen dosage for children. It recommends checking with a physician before giving acetaminophen to children under 2 years old and advises reading drug labels to determine the appropriate dosages based on children’s weight. 

    Apart from a Trump Truth Social post, the administration’s written communication has focused on acetaminophen use during pregnancy. When we asked the White House and HHS if its official guidance is that children should not take acetaminophen, the agency did not answer that question.

    Are there any risks if I don’t give my feverish child acetaminophen? 

    There can be risks, yes. Children who have high fevers and significant pain from a sore throat, for example, are at risk of becoming dehydrated without adequate treatment. 

    “Dehydration is serious and if severe enough can lead to organ damage,” van der List said. “Dehydration may require hospitalization for intravenous fluids and management of electrolyte changes, hypoglycemia and organ dysfunction.”

    Rand said that from about the age of 6 months to 5 years old, fevers can cause febrile seizures in about 3% to 4% of children. Such seizures usually last less than one to two minutes; they can be frightening, but they don’t typically lead to long-term complications.

    “If this occurs, you should contact a doctor for evaluation but also treat the fever to make the child more comfortable,” Rand said.

    Is there anyone who shouldn’t take acetaminophen? 

    People with liver disease or hepatitis can’t process acetaminophen very easily, making them more vulnerable to liver damage from the medication. 

    In rare cases, acetaminophen can cause serious skin reactions, Stevens-Johnson Syndrome and acute generalized exanthematous pustulosis. Symptoms include red skin, rash and blisters. If a skin reaction occurs when your child is taking an acetaminophen-containing medication, the FDA advises that you stop using that medication and seek medical attention immediately. People who have had a serious skin reaction after taking acetaminophen should avoid the medication going forward, the agency said.

    People with acetaminophen allergies should also avoid taking the drug.

    Trump warned parents against giving Tylenol with vaccines. Is this something I should avoid?

    After a vaccine, acetaminophen might be warranted to treat symptoms such as fever, discomfort or irritability and persistent crying that signal pain, Muñoz said.

    But Rand said parents should avoid giving it to a child before the vaccine is given. “There is some evidence to show it may reduce the immune response,” she said. 

    Does taking acetaminophen increase my child’s risk of autism?

    No research shows taking acetaminophen as a child causes increased risk of autism. A 2021 study in the European Journal of Epidemiology looking into the matter did not find an association between exposure to acetaminophen after a child is born and autism.

    Researchers say that there is no single factor that can explain all autism diagnoses. Autism is a complex neurological condition that influences how someone acts and communicates. Research signals that genetics play a significant role in the likelihood someone will have autism.

    Higher paternal age and maternal use of a drug called valproate, which is used to treat epilepsy and bipolar disorder, increases risk, research has found. Low birth weights and a mother’s fever or illness during pregnancy have also been linked to autism, the Autism Science Foundation said. 

    A 2022 European Journal of Pediatrics review of existing research concluded that acetaminophen “has been proven safe for liver function in infants and in small children, even at doses higher than those currently recommended,” but was “never shown to be safe for neurodevelopment.” It did not prove acetaminophen was unsafe for neurodevelopment.

    RELATED: RFK Jr.’s statements about autism and environmental toxins conflict with ample research

    RELATED: Research doesn’t show using Tylenol during pregnancy causes autism. Here’s what else you should know

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  • ONA Condemns President Trump’s Statements On Acetaminophen And Pregnancy – KXL


    The Oregon Nurses Association disputes President Trump’s claim about acetaminophen and pregnancy. Acquired Through MGN Online on 04/08/2020

    PORTLAND, OR – The Oregon Nurses Association has issued a statement condemning President Trump’s recent comments advising that pregnant women “avoid Tylenol at all costs” and announcing plans for the Food and Drug Administration to require new warning labels against the use of acetaminophen in pregnancy.  ONA said the president’s claims are not supported by scientific evidence and risk undermining public trust in evidence-based care.

    “The President’s statements appear to be yet another ideologically driven attack on public health designed to score cheap political points,” they said.

    According to ONA statement, there is no causal link between acetaminophen use during pregnancy and autism or other neurodevelopmental disorders, such as autism, and that suggesting otherwise spreads misinformation, creates unnecessary fear among pregnant patients and families, and may lead to the undertreatment of pain and fever during pregnancy, which can create health risks for mothers and babies.

    “We call on President Trump, his allies in Congress, and the Secretary of Health and Human Services to respect science, protect public health, and support the frontline caregivers who care for patients and families across the country,” ONA officials wrote. “Spreading unsubstantiated claims on issues as sensitive as maternal and child health is not good for patients, not good for caregivers, and not good for Oregonians.”

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    Tim Lantz

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  • Science in the Spectacle

    On Monday, September 22nd, millions of Americans tuned in to watch our nation’s leaders announce a correlation between the common pain reliever acetaminophen (Tylenol) and autism. As no surprise, the language was unprofessional and accusatory. The press conference was chaotic, but behind the chaos, some good points were made.

    The central claim was simple: studies have raised questions about whether prenatal use of acetaminophen may increase the risk of autism or ADHD in children. The reality is far more complicated. The science is not settled. Some research suggests a weak association, while others find no link. No causal connection has been proven. What is certain is that millions of pregnant women rely on acetaminophen as one of the few safe over-the-counter options. The stakes of this announcement were enormous.

    Instead of offering clarity, it produced confusion. Pregnant women across the country were left wondering whether to throw away the only medication their doctors had long assured them was safe. Wondering if they were the reason their child has autism. Families who already distrust government health guidance now feel more justified in ignoring medical advice. Meanwhile, pharmaceutical companies are demonized without evidence, as though medicine itself were the enemy.

    This is the wrong way to communicate science.

    We’ve seen this play out before. From the mixed messaging during COVID to the ever-shifting vaccine guidance, Americans have been whiplashed by a stream of warnings and politically charged statements. Each time, trust erodes more. Announcing an unsettled scientific finding with the flourish of a campaign rally doesn’t inform people; it terrifies them.

    To me, the CDC isn’t just a federal agency; it’s my neighbor. I walk past its gates on my way to class. Inside those buildings, scientists are undertaking some of the most challenging work in the world. Outside those gates, their voices are drowned out by politicians who treat public health like a prop. That disconnect, between the science and the show, is exactly why trust in health institutions is in freefall. To be clear: it is right for the government to investigate potential risks to maternal and child health. It is right to be cautious, to study the data, to give families the best information available. But how we share that information matters. Panic is not prevention.

    Warning without context is not protection.

    So what should have happened? First, the announcement should have come from scientists. The CDC and FDA should be leading these conversations, explaining clearly what we know, what we don’t, and what research is underway. Second, the message should have included practical guidance for patients: Talk to your doctor. Don’t stop medications abruptly. Watch for further updates as studies progress. Finally, the rollout should have modeled humility, the courage to say, “We’re still learning.” That kind of honesty builds trust, not fear.

    Millions tuned in hoping to learn whether Tylenol is safe. What they got instead was another reminder of how fragile trust in public health has become. We deserve better than a circus.

    The opinions expressed in this commentary are those of the writer and not necessarily those of the The Atlanta Voice.

    Caroline Rubin

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  • Trump is wrong about Tylenol use in pregnancy

    Obstetricians have long advised their pregnant patients that Tylenol is the safest option to reduce fever or pain. President Donald Trump stood before a national audience on Sept. 22 and contradicted that.

    “Don’t take Tylenol,” Trump said during an hourlong White House press conference that included his leading health appointees. “There’s no downside. Don’t take it. You’ll be uncomfortable. It won’t be as easy, maybe, but don’t take it. If you’re pregnant, don’t take Tylenol.” 

    His advice has no clear basis in research and contradicts longstanding science and medical guidance. And there are downsides to avoiding acetaminophen, the active ingredient in Tylenol, when it is needed. Untreated fever during pregnancy can harm a mom and baby, medical experts warn. Untreated pain is a drawback, too. 

    Trump’s advice is based on the unproven idea that acetaminophen use during pregnancy increases a child’s risk of autism — a stance that he and Robert F. Kennedy Jr., the longtime anti-vaccine activist Trump tapped as health secretary, touted throughout their address.

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    Although some studies have found that children exposed to acetaminophen during pregnancy were more likely to have autism symptoms or be diagnosed with autism, other studies found no such association. Association is not the same as causation. That means that research showing an association between Tylenol and autism doesn’t mean the medication caused autism. 

    The U.S. Food and Drug Administration’s Sept. 22 press release on the topic said as much. 

    “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,” it said. “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.” 

    The White House declined to provide data showing there are no downsides to avoiding Tylenol use. It provided a statement from White House Press Secretary Karoline Leavitt in which she cited “a connection” between acetaminophen use during pregnancy and autism as the reason for the guidance.

    “The Trump Administration does not believe popping more pills is always the answer for better health,” Leavitt said.

    Leavitt also shared on X a statement from Dr. Andrea Baccarelli, a dean at Harvard T.H. Chan School of Public Health, who said his research “found evidence of an association” between prenatal acetaminophen exposure and neurodevelopmental disorders in children. Baccarelli warned of the risks of high fever and advocated for cautious acetaminophen use during pregnancy — not blanket avoidance.

    RELATED: Fact-checking Trump’s claims on Tylenol, autism and vaccines

    Acetaminophen is safe during pregnancy. Untreated fevers are not.

    Maternal and prenatal care groups, including the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, support the use of acetaminophen during pregnancy.

    They reiterated this support again in response to or in expectation of Trump’s remarks. 

    There’s good reason for that: Acetaminophen is one of few safe options pregnant patients have to treat fever and manage pain. 

    Trump acknowledged this during the press conference. 

    “Sadly, first question: What can you take instead?” he said. “There’s not an alternative.” He said that other medicines such as aspirin and Advil “are absolutely proven bad.”

    President Donald Trump speaks at the White House, Sept. 22, 2025, alongside others. From left: National Institutes of Health Director Dr. Jay Bhattacharya, FDA Commissioner Dr. Marty Makary, HHS Secretary Robert F. Kennedy Jr., Centers for Medicare & Medicaid Services administrator Dr. Mehmet Oz, Dr. Dorothy Fink, acting assistant secretary for health, and Jackie O’Brien. (AP)

    In 2023, the FDA advised that nonsteroidal anti-inflammatory drugs, or NSAIDs, which includes common pain relievers such as Advil, Aleve — also known as ibuprofen or naproxen, respectively — and aspirin shouldn’t be used during pregnancy after 20 weeks of gestation.

    Those medications aren’t recommended during pregnancy because they could harm fetal development, Dr. Salena Zanotti, an obstetrician and gynecologist, told Cleveland Clinic earlier this year. 

    Untreated fevers during pregnancy come with their own risks.

    In a Sept. 22 statement, Dr. Steven J. Fleischman, ACOG’s president, said the Trump administration’s anti-Tylenol advice sends a “harmful and confusing message” to pregnant patients.

    “Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it,” Fleischman said. 

    Dr. Christopher Zahn, ACOG’s chief of clinical practice, said pregnant patients should talk with their doctors about the benefits and risks of available treatments. Avoiding treating medical conditions that call for acetaminophen is “far more dangerous than theoretical concerns based on inconclusive reviews of conflicting science,” Zahn said.

    Similarly, the Society for Maternal-Fetal Medicine said that untreated fever and pain during pregnancy carries “significant maternal and infant health risks.” 

    “Untreated fever, particularly in the first trimester, increases the risk of miscarriage, birth defects, and premature birth, and untreated pain can lead to maternal depression, anxiety, and high blood pressure,” it said. 

    The research on this goes back more than a decade: A 2014 Pediatrics review of available evidence on fevers during pregnancy found “substantial evidence” that maternal fever might negatively affect fetal health in the short and long term, including increasing the risks of neural tube defects, congenital heart defects and oral clefts.

    The U.S. Centers for Disease Control and Prevention also says that fever during pregnancy has been linked to adverse outcomes including birth defects. 

    MotherToBaby, a nonprofit organization that provides information about the benefits or risks of medications and other exposures during pregnancy and while breastfeeding, warns that a fever-caused increase in body temperature during early pregnancy carries risks, including a small chance for birth defects. Some studies also found that fevers are associated with increased chances of a child having attention-deficit/hyperactivity disorder or autism.

    Kenvue, Tylenol’s parent company, said acetaminophen is “the safest pain reliever” option available throughout an 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’s statement said. “High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.”

    Tylenol, responding to the news attention on Instagram, cited the ACOG position on acetaminophen use during pregnancy and highlighted a section of the Tylenol label that encourages people who are pregnant or breast feeding to talk to a health professional.

    “Your doctor is the best person to advise whether taking medication is right for you based on your specific health needs,” the video said.

    Our ruling

    Trump said “there’s no downside” to avoiding Tylenol use during pregnancy. 

    Researchers have long documented health risks associated with untreated fevers during pregnancy. They can lead to increased risk of birth defects and other pregnancy complications, particularly in the first trimester. Untreated pain can lead to maternal depression, anxiety and high blood pressure. These risks outweigh conflicting research into possible links between the drug and autism, according to maternal and fetal health organizations. 

    Doctors and researchers have found acetaminophen to be a safe pain and fever reducer during pregnancy. By comparison, other over-the-counter pain relievers come with documented risks, making Tylenol one of the only options available to pregnant mothers. 

    We rate Trump’s statement Pants on Fire!

    RELATED: Research doesn’t show using Tylenol during pregnancy causes autism. Here’s what else you should know 

    RELATED: RFK Jr.’s statements about autism and environmental toxins conflict with ample research

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  • Trump’s misleading claims about Tylenol and autism

    President Donald Trump warned U.S. women to stop taking Tylenol in pregnancy or risk giving their children autism. The advice came with no clear scientific basis during an hourlong press conference as he stood beside the nation’s top health officials, including the anti-vaccine activist he appointed to lead U.S. health policy.  

    “Taking Tylenol is not good,” Trump said Sept. 22 at the White House with U.S. Health and Human Services Secretary Robert F. Kennedy Jr. beside him.

    Pregnant women have relied on acetaminophen — the active ingredient in Tylenol and other medications — for decades to relieve pain and reduce fever. It’s often the only medication OB-GYNs recommend to their patients experiencing high fevers. Untreated fevers can pose health risks for pregnant women and their developing babies. 

    As PolitiFact has reported, research so far does not provide conclusive support for Trump’s warning. Some studies have found an association between acetaminophen use during pregnancy and autism prevalence, while others have found none. None of the research has proven it causes autism in children. Autism was first identified in 1943, more than a decade before the U.S. Food and Drug Administration approved Tylenol for use over-the-counter.

    Trump touted the promise of leucovorin in treating autism. The drug is a form of vitamin B9, also known as folate, traditionally used to combat the toxic effects of certain cancer drugs. He also repeated a number of other wrong or misleading statements about autism and vaccines.

    Trump: “Since 2000, autism rates have surged by much more than 400%.”

    Autism prevalence among children has increased over the years, but Trump’s statement  misses important context about the reasons behind the rise, including the increase in autism screening, diagnosis and awareness.

    In 2000, the U.S. Centers for Disease Control and Prevention estimated 1-in-150 8-year-olds had autism. In April, the CDC announced that prevalence had risen to 1-in-31. This represents a roughly 383% increase.

    Scientists, including the CDC, have largely attributed the rise to better screening, changes in diagnostic requirements, wider access to services and increased public awareness.

    The CDC based its most recent finding on 2022 surveillance data from 16 sites across 15 states and territories. Autism’s prevalence varied widely by location. The report’s 52 authors attributed those inconsistencies to different ways autism is evaluated and identified, the availability of screenings and financial barriers that can limit families’ access to services.

    In the mid-1990s, researchers began to see autism as a condition that presents in a broad spectrum of symptoms with varying degrees of severity. By 2013, clinicians formally adopted a single autism spectrum disorder diagnosis that includes people with a range of treatment needs.

    Autism advocates have raised awareness of the condition. As more services have become available to autistic children, families increasingly seek out formal testing. A child’s autism spectrum disorder diagnosis makes special education services more accessible and insurance coverage more likely.  

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    Trump: “There are certain groups of people that don’t take vaccines and don’t take any pills that have no autism,” including the Amish and Cubans.

    We rated a similar claim about the Amish Pants on Fire in 2023. Studies have documented cases of autism among Amish children.

    The Amish, a Christian group known for rejecting modern conveniences and technological innovation, tend to have lower-than-average vaccination rates. However, some still vaccinate their children, with rates varying among settlements and different vaccines. 

    University of Maryland genetic epidemiologist Braxton Mitchell, who has studied Lancaster, Pennsylvania’s large Amish communities, previously told PolitiFact that childhood vaccines, which include shots for rotavirus, polio, tetanus and whooping cough, are more accepted among Amish people than other vaccines. 

    Trump also said “there’s a rumor” that Cubans don’t have Tylenol and “have virtually no autism.” 

    Acetaminophen is sold in Cuba under the name “paracetamol,” although shortages of the drug sometimes arise, according to The Latin Times. 

    Cuba also has documented cases of autism. A 2017 report in a peer-reviewed journal focused on Cuban health included a government estimate that 1-in-2,500 Cuban children have autism. That’s likely an undercount because of poor data and surveillance, it said. 

    Trump: “Hepatitis B is sexually transmitted. There’s no reason to give a baby that’s almost just born hepatitis B.”

    That’s misleading. 

    Hepatitis B can be transmitted sexually, but it’s not the only way. It can be spread through direct contact with blood or from a mother to child during delivery. More mundane household contact can also result in transmission. Small amounts of dried blood on innocuous household items such as nail clippers, razors or toothbrushes could be enough. 

    Around half of people with hepatitis B are unaware they are infected and contagious. The vaccine dose is given to newborns within 24 hours of delivery because hepatitis B infections are extra dangerous for babies. Infected infants have a 90% chance of developing the disease’s more dangerous chronic form, which can cause cirrhosis and liver cancer. A quarter of those babies will go on to die prematurely from the disease when they become adults. 

    Trump: “Don’t take Tylenol. There’s no downside…don’t take it if you’re pregnant.”

    This is wrong. Acetaminophen reduces fever, and fever during pregnancy has been linked to birth defects and other health problems.

    Untreated fever and pain during pregnancy has significant maternal and infant health risks, including miscarriage and preterm birth, according to the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists.

    Doctors have also said that abstaining from needed medication could leave pregnant women in a negative emotional and mental state with worsening underlying conditions.

    Trump: “Now, you know what mercury is, you know what aluminum is. Who the hell wants that pumped into a body?”

    Vaccine critics often cite aluminum and mercury as problematic vaccine ingredients. But these blanket statements leave out important details about the chemistry and the quantity used. Health officials warn pregnant and breastfeeding women against consuming too much mercury, which can be found in seafood in safe and hazardous levels. But those warnings are about methylmercury, which is different from the kind of mercury used in vaccines. 

    Thimerosal, a preservative that prevents bacteria and fungal growth in multi-dose influenza vaccine vials, contains ethylmercury. Unlike methylmercury, which can accumulate and cause harm, ethylmercury is broken down by the body and excreted quickly making it less likely to cause harm.

    Thimerosal was removed from most vaccines, including all childhood vaccines, as of 2001, according to the CDC. Numerous scientific studies have found no link between thimerosal and autism.

    Some vaccines contain a small amount of aluminium to enhance the body’s immune response. Although large amounts of aluminum can be harmful, vaccines contain less aluminum than infants get from their natural surroundings. 

    According to the Children’s Hospital of Philadelphia, babies get about 4.4 mg of aluminum from vaccines in their first six months; they get around 7 mg from breastmilk and around 38 mg from formula in the same time. 

    Trump: Questioning how vaccines are administered to children, “Maybe it’s the doctors they get, maybe more money.”

    Trump advocated for childhood vaccines to be split up into multiple doses — a practice that exists for most childhood vaccines. As he spoke, he questioned if doctors have a financial incentive when it comes to administering vaccines. 

    A close look at the process by which vaccines are administered shows pediatric practices make little profit — and sometimes lose money — on vaccines.

    Pediatric practices might make money providing vaccines to privately-insured children, but many also participate in a program that vaccinates children for free. Overall, most practices likely break even or lose money.

    Doctors told us that evidence-based science and medicine and a desire to keep kids healthy drives doctors’ childhood vaccination recommendations.

    Staff Writer Madison Czopek contributed to this report.

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  • Trump and RFK Jr. Blame Tylenol For Autism in New Report, but Experts Push Back

    President Donald Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. have officially found scapegoats to blame for rising rates of reported autism cases. In a report published today by HHS, the government has linked the use of acetaminophen (better known as Tylenol) during pregnancy to the neurodevelopmental condition.

    Trump made the announcement at a news conference Tuesday afternoon, though the Wall Street Journal was the first to break the news on the expected findings earlier this month. The report singles out acetaminophen use and folate deficiency as possible autism causes and even suggests a specific drug used to improve the latter—leucovorin—as a potential autism treatment.

    “Taking Tylenol is not good—I’ll say it, it’s not good,” Trump stated decidedly during the conference, though he went on to admit that there are no safer alternative over-the-counter painkillers for pregnant women to take. RFK Jr., meanwhile, stated that the FDA will be taking formal steps to add a safety label to acetaminophen products warning of its supposed autism risk, while HHS will be conducting a public health campaign to highlight the link.

    Outside experts are dubious about the report, however, arguing that its findings are based on weak and mixed evidence, at best.

    Why Tylenol is a red herring

    Perhaps the biggest red flag surrounding this report is Trump and RFK Jr.’s grandiose language advertising it. Both men have crowed about finding the singular cause or answer to autism spectrum disorder.

    “I’ve been waiting for this meeting for 20 years.” Trump said during the news conference. “And it’s not that everything is 100% understood or known. But I think we’ve made a lot of strides.”

    Actual scientists, however, have long known that autism is generally triggered by a mix of genetic and environmental influences—influences that aren’t easily untangled.

    The rate of reported autism cases in children has gone up over time. Many experts have argued that a greater awareness of autism symptoms and broader criteria in how autism is diagnosed are largely responsible for this increase. But Trump, RFK Jr., and others have refused to accept this conclusion, and have instead looked to point a finger at some external culprit in the environment.

    Some environmental factors could be contributing slightly to more autism cases, such as people having children at an older age than before, but there are good reasons why Tylenol is unlikely to be a good villain for the Trump administration to blame.

    “There’s nothing new here. They are reviewing existing literature, and they’re doing it badly,” David Mandell, an autism researcher and psychiatric epidemiologist at the University of Pennsylvania, told Gizmodo. Mandell is also an executive committee member of the Coalition of Autism Scientists, an organization that formed in response to RFK Jr.’s initial announcement earlier this April that he would supposedly uncover the causes of autism.

    Some studies, including a review published last month, have suggested that prenatal exposure to acetaminophen could increase the risk of several neurodevelopmental disorders, such as autism and attention-deficit/hyperactivity disorder (ADHD). Importantly, though, many other studies haven’t, including studies that have tried to account for the weaknesses in the data being analyzed.

    In a 2024 study, researchers in Sweden and the U.S. looked at the health outcomes of all children born in Sweden between 1995 and 2019. At first, they did find a small signal of potential autism risk in kids whose mothers reported using acetaminophen during pregnancy. This signal disappeared entirely when they only focused on comparing siblings to each other, however. Since siblings share many of these influences, this type of study can better isolate and cut down on potential noise in the data that could lead researchers down the wrong path.

    Indeed, based on their results, the researchers concluded that the link between Tylenol and disorders like autism was probably a “noncausal association.”

    Some research has also suggested that acetaminophen use among pregnant women in the U.S. and Canada has actually declined slightly since the early 2000s, Mandell notes, the opposite trend you’d expect to see if the drug was truly driving higher autism rates.

    Notably, other countries have already tried to distance themselves from the U.S.’s new stance on Tylenol. The UK’s health regulators issued a statement today reassuring its residents that the use of acetaminophen (called paracetamol in Europe) during pregnancy is safe and that there is no evidence of it causing autism.

    The tenuous case for leucovorin

    The link between folate deficiency/leucovorin and autism in the new report is built on less shaky, but still tenuous, ground.

    Folate is also known as vitamin B9, and expectant mothers need adequate levels of it to support their child’s health during pregnancy and prevent certain birth defects. That’s why women are recommended to regularly take folic acid (another form of vitamin B9 that breaks down into folate in the body) supplements while pregnant.

    Research has suggested that some children with autism also tend to have trouble moving folate into their brains (usually due to an autoimmune issue), which then causes a condition called cerebral folate deficiency (CFD). Importantly, people can have CFD but still have normal folate levels in their blood. Leucovorin is a different form of vitamin B9 (folinic acid) that’s most commonly used to counteract the toxic effects of some chemotherapy treatments. But the drug can also bypass the typical method for folate delivery, meaning it can raise folate levels in the brain and treat CFD.

    Based on this early research, some scientists have been excited about the potential of leucovorin to help children with both autism and CFD. Some clinical trials have yielded promising results, while some parents have claimed that leucovorin dramatically improved their children’s communication and developmental skills. All that said, the trials have been small to date, with the largest so far involving 80 children (a similar trial of 80 children is expected to be completed next year) and the smallest only having 19 children.

    Leucovorin could absolutely turn out to be an effective treatment for the subset of children who seem to have both conditions, but Mandell is worried about the Trump administration rushing through the scientific process in hopes of securing good publicity. When I asked if the administration is putting the cart ahead of the horse with leucovorin, Mandell replied, “We don’t even know if there is a cart yet.”

    Mandell also cautions that both researchers and the autism community have had their hopes raised—only to be dashed—by early, promising studies in the past. Over 20 years ago, he notes, much was made about the potential of secretin, a neurotransmitter that helps regulate digestion, to treat autism symptoms. Case reports and small trials appeared to show a positive effect from secretin, only for multiple larger trials to later find nothing of the sort.

    This cautionary tale has not stopped Trump and Kennedy from quickly moving to promote and even approve leucovorin for autism via the FDA. The FDA is publishing a Federal Register notice outlining a label update for leucovorin, according to HHS, which will formally authorize a prescription version of the drug for treating autism.

    “If folinic acid gets an FDA indication for autism, it would be the drug with the weakest evidence to support its FDA indication of any drug that I can think of,” Mandell said.

    Mandell and others have also noted some groups close to Trump world could potentially profit handsomely if leucovorin becomes popularized as an autism treatment. Mehmet Oz, the current administrator of the Centers for Medicare & Medicaid Services, was previously an advisor to the supplement company iHerb, for instance, which has several listings for folinic acid supplements on its website. Oz himself pledged to resign from the company and divest his restricted stock units from iHerb upon becoming CMS chief.

    The future of autism research

    The government’s approach to autism and research is now taking shape. That said, under the Trump administration, the National Institutes of Health has actually cut funding this year from its existing autism-related efforts, either due to negligence or as part of a larger crusade to tear down anything in the government that even acknowledges racial and other disparities for being too “woke.”

    Mandell and other experts worry that the administration’s new focus on acetaminophen and leucovorin will only lead to more wasted resources and fearmongering about an important intervention. Compared to aspirin and NSAIDs, Tylenol is considered a safer OTC pain and fever reliever for pregnant women, and it’s estimated more than half of women worldwide take the drug at least once during pregnancy.

    Unfortunately, the scapegoating may not be over yet.

    The HHS report notably doesn’t focus on vaccination, which Kennedy, other antivaccination proponents, and even Trump have long tried to blame for rising autism rates. Extensive scientific research over the years has and continues to find no such link between vaccines or their ingredients and autism. But HHS has reportedly hired well-known antivaxxer David Geier to conduct a new study reexamining this debunked connection.

    During the news conference, Trump tried to relitigate the case for separating out the measles, mumps, and rubella combination vaccine (a common goal of the anti-vaccination movement), arguing that taking too many vaccines at once is dangerous to people’s health, a claim with little backing. RFK Jr. also made it clear during the conference that HHS will be investigating the purported link between vaccines and autism, somehow framing it as a matter of “believing all women”—referring to the mothers who believe vaccines cause autism.

    Acetaminophen may be the first fake bogeyman that Trump and Kennedy will formally blame for autism, but it seems unlikely that it will be the last.

    Ed Cara

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  • WATCH LIVE: Trump administration suggests Tylenol during pregnancy causes autism, a link experts say is unproven

    By ALI SWENSON and AMANDA SEITZ

    WASHINGTON (AP) — President Donald Trump suggested Monday that the use of Tylenol during pregnancy may contribute to rising autism rates in the U.S., a potential link experts have studied and say is unproven.

    Associated Press

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  • 5 things to know about autism and Tylenol during pregnancy

    For years, Tylenol has generally been considered safe for treating pain and fever — even during pregnancy, when doctors discourage patients from using many medications. 

    Doctors might even recommend taking Tylenol for pain or fever during pregnancy, because left untreated, they can pose their own health risks. 

    But recent news reports about the federal government connecting Tylenol to autism have drawn fresh questions about the drug, and concerns. 

    A few things are clear.

    After years of research, no study has shown that acetaminophen, the main ingredient in Tylenol, causes autism. There’s no known single cause of autism, a neurological condition that influences how someone acts and communicates.

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    But some scientific terms, like “association,” can confuse the issue. There’s some research that says there’s an association between taking acetaminophen during pregnancy and autism. There’s also some research that says there’s not an association. 

    But either way, there’s an important caveat: “Association” is not the same as causation. That means that research showing an association between the medication and autism doesn’t mean the medication caused autism. 

    Here’s what else you should know.

    #1: Doctors say it’s safe to use acetaminophen to reduce fever and pain during pregnancy. 

    After the Wall Street Journal reported on Health Secretary Robert F. Kenndy Jr.’s plans to link Tylenol to autism, leading maternal and prenatal care organizations reiterated their longstanding support for using acetaminophen during pregnancy. 

    The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine said acetaminophen is a safe way to treat pain and fever when used in moderation. 

    “Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief,” said Dr. Christopher Zahn, ACOG’s chief of clinical practice. 

    In fact, Dr. Salena Zanotti, an obstetrician and gynecologist, told Cleveland Clinic earlier this year that acetaminophen is considered the safest drug to take during pregnancy for fever and pain. 

    “When you’re pregnant, it’s riskier to have an untreated fever than it is to take acetaminophen,” Zanotti said.

    Other common pain relievers such as ibuprofen or naproxen — often sold as Advil or Aleve, respectively — aren’t recommended during pregnancy because they could harm fetal development, Zanotti said. The Food and Drug Administration said as much in 2023, advising that such nonsteroidal anti-inflammatory drugs, or NSAIDs, shouldn’t be used during pregnancy after 20 weeks of gestation.

    #2: Having an untreated fever while pregnant can harm a baby. 

    Ignoring medical conditions such as fever that could be treated with acetaminophen during pregnancy is “far more dangerous than theoretical concerns based on inconclusive reviews of conflicting science,” Zahn said. 

    The Centers for Disease Control and Prevention says that fever during pregnancy has been linked to adverse outcomes including birth defects. 

    Untreated fever and pain during pregnancy has maternal and infant health risks, including preterm birth, according to the Society for Maternal-Fetal Medicine. 

    Generic acetaminophen capsules in Santa Ana, California. (AP)

    #3: Research has not shown that using acetaminophen during pregnancy causes autism. 

    No study has shown using acetaminophen during pregnancy causes developmental disabilities — including autism. 

    But the language used in scientific research can be confusing. Words like “correlation,” “association,” and “increased risk,” in studies about acetaminophen use during pregnancy do not mean that the medication caused a disability like autism.  

    “Both ‘association’ and ‘increased risk’ are very different from ‘proven causal link,’” said Christopher J. Smith, chief science officer at Southwest Autism Research & Resource Center.  

    The FDA, the Society for Maternal-Fetal Medicine and ACOG have all reviewed the available research on acetaminophen use during pregnancy and subsequent neurodevelopmental issues in children and found no evidence proving the medication caused those disabilities, Zahn said.

    “The vast majority of the studies done on acetaminophen use in pregnancy are inconclusive and unable to confirm a causal relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues,” he said.  

    #4: Some research has shown possible associations between prenatal acetaminophen exposure and childhood development — but here’s what that means.

    For more than a decade, scientists have investigated potential associations between using acetaminophen during pregnancy and developmental disabilities. 

    Some studies have found positive associations between acetaminophen and autism, meaning children whose mothers took the drug during pregnancy were more likely to later have autism symptoms or be diagnosed with autism. 

    A 2025 Mount Sinai study that reviewed some existing research concluded the available evidence supported an association between prenatal acetaminophen exposure and increased incidence of neurodevelopmental disorders. 

    But the largest study on this topic, from 2024, found no evidence supporting an increased risk of autism, attention-deficit/hyperactivity disorder or intellectual disability associated with acetaminophen use during pregnancy. 

    The 2024 study is one of the two highest quality studies on the topic, Zahn said, and neither found an association between acetaminophen use and adverse neurodevelopmental outcomes.

    What does this mean for confused parents? Associations between acetaminophen and autism are “based on limited, conflicting, and inconsistent science and is premature given the current science,” according to the Autism Science Foundation.

    There’s yet another wrinkle: the potential for “publication bias,” a phrase that describes when scientific publications avoid publishing findings that don’t show significant associations. That means studies that don’t find an association between autism and acetaminophen are less likely to be accepted for publication, said Dr. Judette Louis, dean of Old Dominion University’s medical school and chair of the Society for Maternal-Fetal Medicine publications committee. 

    #5: An association between prenatal acetaminophen exposure and autism might be explained by other factors. 

    Research has shown that genetics plays a role in autism. Hundreds of genes have been linked to autism, as have some environmental factors such as how old parents are when a child is conceived, low birth weights, and fever or illness during pregnancy, the Autism Science Foundation said.

    Brian Lee, a Drexel University epidemiology professor, coauthored the 2024 study, which evaluated data on nearly 2.5 million births in Sweden from 1995 to 2019 to assess acetaminophen use during pregnancy and the risk of autism. The study initially replicated a small statistical association between acetaminophen use and the risk of autism and ADHD, Lee said.

    “However, when we did a sibling analysis that compared siblings (born to the same mother), the association completely went away,” he said. “We do the sibling analysis because it allows us to control for genetic and environmental factors that we do not otherwise have data on.”

    The sibling analysis showed that other factors caused the initial statistical association, Lee said. The paper highlighted the possibility that genetics acted as a variable that could predict both a mother’s use of pain relief medication and a child’s risk of autism.  

    A mother’s genetic predisposition for autism and ADHD, which is also genetic, is associated with “greater pregnancy pain, more headache and migraine, and more use of pain-relieving medications,” Lee said. In other words, mothers who are genetically predisposed toward autism or ADHD are more likely to have conditions that cause them to use acetaminophen — and that same genetic predisposition could be what increases the likelihood of a child having those conditions.

    Another consideration: Many studies rely on parents self-reporting acetaminophen use, so the data could be unreliable. 

    Someone might be more likely to remember taking acetaminophen during pregnancy if their child has autism or ADHD, for example — especially if they think there could be a connection between the drug and the diagnosis, according to Dr. Erin Clark, a University of Utah obstetrics and gynecology  professor. A person might also be less likely to remember taking acetaminophen during pregnancy if their child hasn’t received such a diagnosis.

    Zoe Gross, director of advocacy at the Autistic Self Advocacy Network, said other considerations might explain any association between acetaminophen and autism. Conditions that cause someone to take acetaminophen during pregnancy — such as fever or migraine — might increase the likelihood that a child will be autistic. 

    RELATED: RFK Jr.’s statements about autism and environmental toxins conflict with ample research

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  • FDA-Mandated Tweak to Common Rx Painkillers May Have Saved Lives

    FDA-Mandated Tweak to Common Rx Painkillers May Have Saved Lives

    By Alan Mozes 

    HealthDay Reporter

    WEDNESDAY, March 8, 2023 (HealthDay News) — Acetaminophen, a popular over-the-counter medication for millions struggling with pain and fever, can also be found in prescription painkillers that combine acetaminophen and an opioid into one pill.

    The problem? The U.S. Food and Drug Administration has long known that high dosages of acetaminophen (Tylenol) can harm the liver. So, in 2011 the FDA set new safety limits on exactly how much acetaminophen could be packed into any prescription painkiller.

    Now, a new study shows the move likely saved lives.

    Ever since the FDA announced the regulatory change, which slashed the limits on acetaminophen from up to 750 milligrams (mg) to up to 325 mg, there has been an 11% to 16% annual drop in the number of hospitalizations and acute liver failure cases involving the combo painkiller. One such combo is Vicodin, which contains hydrocodone and acetaminophen.

    “This suggests that the mandate was likely the largest driver in the decreases in acute liver failure cases and hospitalizations in combination acetaminophen-opioid products,” said study author Dr. Jayme Locke, director of the University of Alabama at Birmingham’s Comprehensive Transplant Institute.

    The report was published in the March 7 issue of the Journal of the American Medical Association. Locke and her colleagues stressed that their investigation does not definitively prove that the FDA mandate directly caused acetaminophen-opioid drug complications to plummet.

    “Certainly, other factors could have played a role,” Locke noted. “For example, the mandate may have brought the issue of acetaminophen toxicity to the forefront for both providers and patients,” presumably leading some to cut down on acetaminophen dosages on their own.

    At the same time, she pointed out that the FDA mandate did not place any new limits on over-the-counter acetaminophen dosing. Not surprisingly, “similar [downward risk] trends were not observed in acetaminophen alone,” Locke said.

    According to the study authors, the intended purpose of combining acetaminophen with an opioid was to enable doctors to expose patients to lower doses of each of the two drugs. Given the burgeoning opioid addiction crisis, that approach made sense.

    But researchers started to warn that at such high doses acetaminophen was proving toxic to the liver.

    In fact, the new report highlights one 2005 study that found more than 4 in 10 of all acute liver failure cases linked to acetaminophen use ended up being traced back to acetaminophen-opioid painkillers.

    In 2009, such red flags prompted an FDA advisory panel to recommend an outright ban on such combo drugs. In the end, the FDA chose the dosage limit route.

    To see if the new limit had a protective impact, Locke’s team analyzed figures compiled by the National Inpatient Sample (NIS) and the Acute Liver Failure Study Group (ALFSG).

    NIS data provided details on roughly 473 million hospitalizations between 2007 and 2019. ALFSG data focused on adult patients who were treated for acute liver failure between 1998 and 2019.

    The investigators then stacked pre-FDA mandate liver failure and hospitalization risk up against post-mandate risk. And what they saw was a dramatic drop in risk, coinciding with the FDA’s 2011 mandate.

    For example, NIS data revealed that while roughly 12 out of 100,000 hospitalizations involved combo drug toxicity just before the FDA move, that figure dropped to just above 4 in 100,000 by 2019. And while the risk for being hospitalized with combo drug toxicity had been increasing 11% a year up to the time of the FDA’s new limit, that figure actually flipped to an 11% drop per year after the limit was announced.

    ALFSG figures revealed a similar dynamic: 27% of acute liver failure cases were attributed to the drug combo at the time of the FDA move, but that figure dropped to 5% by 2019.

    Locke said the study did not identify what percentage of combo drug users struggled with a substance use disorder before or after the FDA move. Nor did the team assess whether the new acetaminophen limit in any way reduced the potency of acetaminophen-opioid combinations.

    But based on the evidence, Locke said her team is “pleased with the effectiveness of the mandate at decreasing acute liver failure cases.”

    Dr. Marc Ghany, section chief of clinical hepatology research at the liver diseases branch at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, co-authored an editorial accompanying the study.

    Ghany suggested that the FDA’s mandate can only go so far, given that combination acetaminophen-opioid formulations only account for about 20% of total acetaminophen use in the United States.

    He pointed out that the study found “the rate of hospitalizations for individuals using non-prescription, over-the-counter acetaminophen-only products actually increased over the same period.”

    The challenge now, said Ghany, is what to do about toxicity risk among the vast majority of patients who use over-the-counter acetaminophen.

    “Efforts to improve consumer education on the risks of acetaminophen injury, and to provide simple and clear information of the risks of liver injury on the product label continue. But this alone may be insufficient, given the general belief among consumers that over-the-counter medications are safe,” he noted.

    “The only way to protect against acetaminophen-related liver injury and death,” said Ghany, “would be to develop safer, more effective pain relievers.”

    More information

    There’s more on acetaminophen at the U.S. National Institutes of Health.

     

    SOURCES: Jayme Locke, MD, MPH, director, UAB Comprehensive Transplant Institute, chief, division of transplantation, and professor of surgery, University of Alabama at Birmingham; Marc Ghany, MD, MHSc, section chief, clinical hepatology research section, liver diseases branch, U.S. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md.; Journal of the American Medical Association, March 7, 2023

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