Acetaminophen

Immunologist and Biochemist Speaks out About Dangers of Acetaminophen for Children

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Immunologist and Biochemist Speaks out About Dangers of Acetaminophen for Children

The use of acetaminophen in babies and in children would never have been approved if it had been tested using current safety standards, claims William Parker, Ph.D.

Parker, who is based in Durham, North Carolina, is an immunologist and biochemist. He conducted research and taught medical school students at Duke University for more than 25 years. He and his colleagues have been researching and writing about the effects of acetaminophen—which is the main ingredient in Tylenol—since 2015.

Acetaminophen Linked to Autism ‘With No Reasonable Doubt’

In one of his most recent studies, co-authored with six other Ph.D. scientists, Parker and his team concluded: “with no reasonable doubt” that acetaminophen causes autism in susceptible babies and children.

“Let me be clear,” Parker told us. “This is not a hypothesis. We have enough evidence for a conclusion on this issue.”

The peer-reviewed study was published in July 2022 in the Italian journal Minerva Pediatrics. The co-authors included two scientists in the pharmaceutical industry as well as Dr. Kate Reissner, a professor and neuroscientist at the University of North Carolina.

“Our published conclusion is based on 17 lines of evidence,” Parker explained. That evidence includes small but compelling studies in humans, numerous studies in animal models, and a series of clues that all point toward acetaminophen as a cause of autism.

“Under normal circumstances, if a drug causes permanent behavioral changes in laboratory animals, it will never be tested in humans,” Parker explained. “Those are called pre-clinical trials. If you fail in pre-clinical trials, then they would never try it in a baby human, if it’s hurting baby animals.”

Indeed, he has conducted his own studies in laboratory animals showing that acetaminophen is not safe, even when used as currently accepted for human babies. In addition, he pointed to a particularly compelling study by Henrik Viberg, a Swedish scientist, who showed that just two doses of acetaminophen at a very young age cause laboratory mice to lose their ability to learn later in life.

Why Do Pediatricians Still Recommend Infant Tylenol?

Given the growing body of scientific evidence linking acetaminophen to autism, as well as the continued rise in autism rates in the United States and other countries in the industrialized world, why do most pediatricians think acetaminophen is safe for babies and children?

“There are several reasons,” Parker explained when we asked him this question. “It’s thought to be safe by almost everyone, that leads to a consensus bias. Moreover, most children don’t become autistic after taking acetaminophen, which leads to an antidote bias. That’s: ‘hey my grandma smoked all her life and never got lung cancer and lived to 102, so smoking isn’t bad for you.’”

But the real reason, Parker said, is that public health authorities report that it is safe.

“The bottom line is that we just can’t expect a typical pediatrician will know anything regarding the safety of drugs for children beyond what they are told by regulatory agencies,” Parker said. “People assume that the doctors know the latest research, but that’s not their job.”

Parker pointed out that pediatricians are busy seeing patients. So, they rely primarily on regulatory agencies, in particular the FDA and the CDC, to tell them what is safe.

Most pediatricians are not aware that boys who are circumcisedhave twice the prevalence of infantile autism as boys who are not. The connection between circumcision, a surgical procedure that often involves the administration of acetaminophen, and autism are one of the 17 lines of evidence compiled by Parker and his team that led them to conclude that acetaminophen causes autism in susceptible children. But that clue is not common knowledge among pediatricians because neither the FDA nor the American Academy of Pediatrics have issued any warnings about it.

At a pediatric conference in Medford, Oregon, that Jennifer attended several years ago, this question was put to a pediatrician, a tongue-tie specialist based in Portland, Oregon. In his talk, as well as on his website, he specifically stated that parents may use Tylenol post-frenotomy.

Though he admitted publicly that he was aware of the evidence linking Tylenol to autism spectrum disorders, the doctor told the audience of about a hundred Oregon healthcare professionals that there was no other painkiller to recommend, as ibuprofen is not approved for children under six months.

Wrongly Assumed Safe

A team of researchers from Duke University and the University of Montreal reviewed the history of how and why acetaminophen was approved for use in infants, given its very concerning safety record. That peer-reviewed study, published in May 2022 in the European Journal of Pediatrics, explained that acetaminophen was assumed to be safe for babies and children in the 1960s and 1970s because it was found to be safe for a baby’s liver.

The underlying assumption, now known to be false, was that babies and children process drugs the same as adults do. Since acetaminophen damage manifests as liver damage in adults, investigators decided to check for liver function in babies as their only measure of safety. 

“In hindsight, the mistake is obvious,” Parker said. “Nobody ever checked to see if it was causing damage to the baby’s brain. But now we know it does if the child is susceptible.”

More Than a Decade of Research

Are Parker and the scientists working with him rushing to a premature conclusion? Are they overstating their concerns? Are they confusing correlation with causation?

In response to these questions, Parker laughed. Then he launched into a litany of facts:

  • The first paper that showed acetaminophen causes autism was published in 2008, well over a decade ago. 
  • His first review on the topic, with scientists and clinicians at Duke and Harvard, was published more than five years ago.  
  • Among other things, he points out that it took almost three years to complete and publish his study showing when, where, and how the tragedy happened.

“Scientists have been known to rush to a speedy conclusion on occasion,” Parker insisted. “This is not one of those occasions. This pile of evidence is so ripe that it will explode.”

Wrong Focus

In 2020, Johnson & Johnson was ordered to pay $6.3 million for misleading advertising on the packaging of infant Tylenol. Since then, at least 20 lawsuits against Tylenol have been filed, many of them highly publicized.

While the media attention surrounding these lawsuits is bringing important issues to light, Parker said, he believes that the lawsuits may also mislead the public.

Here’s why: these lawsuits are focused on acetaminophen use during pregnancy. But Parker and his colleagues believe that acetaminophen use in babies and in children probably is much more dangerous than acetaminophen use during pregnancy.

“Post-natal use probably causes five or six times more cases of autism than use during pregnancy,” he said.

Could We Make Tylenol Safe?

Parker said it’s very difficult to know in advance what children are more susceptible to brain injury from acetaminophen. He said genetic factors play a role.

Other doctors, including Ben Lynch in Washington and Paul Thomas in Oregon, have said that children who are homozygous for MTHFR mutations are more likely to have difficulty detoxifying. But, Parker said, a variety of other factors—including a depleted microbiome and co-existing autoimmune dysfunction—can stress the immune system.

In December 2015, two medical scientists from the University of Miami found that letting a fever “ride” was supported by several randomized controlled studies. Five months later, a long review article published in Nature Reviews Immunology showed that most fevers are protective, and many should be allowed to run their course. 

There are many natural alternatives to acetaminophen, some of which can be safely given to infants. But Parker also has another suggestion. He said that adding an antidote for the drug’s toxicity might be a way to make it safe.

One such antidote, acetylcysteine, Parker said, is usually well tolerated. “We shouldn’t assume it will work,” he said, “but we could test it easily enough.”

Acetaminophen Overdose Has Become a Leading Cause of Liver Failure in US

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Acetaminophen Overdose Has Become a Leading Cause of Liver Failure in US

In the United States, acetaminophen is widely available and included in hundreds of cold and cough medicines. Unfortunately, it can also be easily misused and has been responsible for deaths by suicide and unintentional poisoning.

Because of its potential dangers, acetaminophen is one of the most frequently banned or restricted drugs (pdf). Countries that have limited or banned drug combinations using acetaminophen include the UK, Norway, India, Algeria, and Kyrgyzstan.

Acetaminophen overdose is the leading cause of liver transplantation in the United States, according to a recently updated report by the National Institutes of Health. About 500 Americans die yearly of complications from acetaminophen toxicity. It also causes approximately 56,000 emergency department visits and 2,600 hospitalizations annually.

Why Is Acetaminophen Toxicity Rate So High?

“Acetaminophen is by far the No. 1 cause of acute liver failure in the United States,” Dr. Nima Majlesi, director of medical toxicology at Staten Island University Hospital in New York, told The Epoch Times.

He noted that most cases result from unintentional chronic acetaminophen overdoses, often due to misuse of medications such as Percocet, Vicodin, and Tylenol PM or taking multiple acetaminophen-containing products without recognizing the danger of high daily doses.

Acetaminophen is sold under many brand names and is an ingredient in a broad range of over-the-counter and prescription medications.

“Medications such as Percocet, Tylenol PM, Robitusson, and Nyquil all can contain acetaminophen,” Majlesi said. “In fact, acetaminophen has been reported to be present in about 600 different products.”

Even though acetaminophen is effective in treating symptoms such as pain and fever, high doses of the medication can be dangerous and cause potentially irreversible liver damage. When acetaminophen is taken in high doses, the liver may be unable to keep up with the breakdown process, and toxic byproducts can accumulate, causing damage to liver cells.

People should take medications as directed, but even then, there’s concern that not all doctors prescribing combination opioid/acetaminophen drugs ensure that patients understand not to take any other acetaminophen medication, according to Dr. Kevin Zacharoff, a chronic pain and substance-use expert.

“What that means is that a significant percentage of people who need liver transplants in the United States need them not because of IV drug abuse or anything else other than the fact that they were ‘poisoned’ in some way by too much acetaminophen,” Zacharoff said.

Accidental Deaths and Suicide

Acetaminophen is often combined with opioid drugs, such as Percocet, and prescribed for pain management. However, many people taking this type of medication are unaware of the presence of acetaminophen, Zacharoff said.

“I think if I said to you, ‘Make sure if I’m prescribing Percocet to you, that you don’t take any other medicine that has acetaminophen in it,’ you may or may not know that Tylenol is another word for acetaminophen,” he said.

People may also be unaware that Robitussin, a common cough medicine, often contains acetaminophen or that common allergy, sinus, and migraine medications may also contain acetaminophen.

“That sets the stage … for people to unintentionally be exposed to too much of it,” Zacharoff said.

The accessibility of the drug also makes it a potential means to commit suicide.

A recent study by the U.S. Centers for Disease Control and Prevention found a 30 percent increase in suicide attempts by poisoning among children in the United States aged 10 to 19 years between 2019 and 2021. The data reveal an even more alarming trend among younger children: Those aged 10 to 12 had a 73 percent increase, and adolescents aged 13 to 15 had a nearly 49 percent increase over that time.

In 2011, Johnson & Johnson, the manufacturer of Tylenol, announced a voluntary reduction of the maximum daily dose for their single-ingredient Extra Strength Tylenol products sold in the United States from eight pills per day (4,000 milligrams) to six pills per day (3,000 milligrams) to decrease the risk of unintentional overdose.

FDA Stance on Acetaminophen

In 2009, a U.S. Food and Drug Administration (FDA) advisory panel voted to recommend banning the combination of acetaminophen and opioid drugs under the brands Percocet and Vicodin and reducing the maximum daily dose of acetaminophen. However, the drug combination is still prescribed in the United States but with generic labels such as hydrocodone and acetaminophen or hydrocodone/APAP.

In 2022, the FDA took steps to address the dangers associated with acetaminophen, including limiting prescription acetaminophen products to 325 milligrams per dose and adding a box warning highlighting the drug’s potential to cause severe liver damage.

“If the FDA truly wanted to reduce the risk of chronic acetaminophen poisoning, it would eliminate all combination preparations and force people to take a pill for each individual medication they needed,” Majlesi said.

This would mean that patients take a single pill for every ingredient contained in their medication.

“This would eliminate much of the confusion that occurs and make medications much safer,” he said.

Acetaminophen May Not Even Help Treat Acute Pain

Acetaminophen has been used since 1878 and might have been assumed to be harmless, like aspirin, another old drug. Unfortunately, some research suggests that acetaminophen use is linked to increased rates of heart attack and kidney failure.

And in addition to the elevated risks of taking it in high amounts, the drug can cause liver failure, even in standard doses, according to research published in Drug Safety in 2013.

Much is still unknown about how acetaminophen acts in the body to relieve pain.

“Nobody really knows exactly how acetaminophen works in the treatment of pain,” Zacharoff said. “There is a fairly well-substantiated basis for acetaminophen being used to treat someone with a fever, as an antipyretic, similar to that of nonsteroidal anti-inflammatories (NSAIDs), but acetaminophen does not have any anti-inflammatory activity in and of itself.”

Growing evidence suggests that acetaminophen may not even work very well for people with chronic pain. In a review of two large clinical trials, researchers found that 4,000 milligrams per day were no better than a placebo for relieving short- or long-term acute lower back pain. The study also shows that acetaminophen was ineffective compared with a placebo in improving sleep quality.

Acetaminophen is often mistakenly considered a conventional NSAID, such as ibuprofen, naproxen, and diclofenac, but it isn’t.

“The pharmacology is very different,” Majlesi said.

He explained that while NSAIDs can cause gastrointestinal irritation, bleeding, and kidney issues when used excessively, acetaminophen can lead to liver failure with chronic overuse. In contrast to NSAIDs, the symptoms of toxicity from acetaminophen aren’t easily recognizable until severe damage has already occurred.

“It is much easier to overdose on acetaminophen because it is very well tolerated in higher doses and exists in combination preps much more frequently than NSAIDs,” Majlesi said.

How to Prevent Acetaminophen Overdose

“As a consumer, you should be aware of every medication that is going into your body,” Majlesi said. “If you are taking combination preparations, then know what each drug in the prep is and why you are taking it.”

He recommended that people stop using brand names when discussing their medications and focus on the generic names of each drug in their daily regimen.

“There is almost no reason anyone should be chronically using a combination preparation containing acetaminophen on a daily basis for more than one week,” Majlesi said.

For individuals in that situation, he recommended having an open conversation with their doctor to question the effectiveness of such a treatment regimen.

“I cannot think of any combination preparation containing acetaminophen that should be used chronically,” Majlesi said.

Acetaminophen, Key Ingredient of Tylenol, May Affect Heart Function

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New research in mice finds acetaminophen may disrupt heart pathways linked to energy, antioxidants, and protein breakdown.

Acetaminophen, Key Ingredient of Tylenol, May Affect Heart Function: Study

That daily backache medication you’ve been popping may be doing more harm than good.

A new study suggests that one of the world’s go-to pain pills, acetaminophen, can trigger unhealthy changes in heart tissue—even at standard adult dosages long considered perfectly safe. Acetaminophen is the active ingredient in Tylenol and many other pain killers.

The findings add to growing concerns over the medication’s wide range of potential side effects.

Acetaminophen Disrupts Crucial Heart Processes

Even moderate doses of acetaminophen are associated with potential risks over time, according to a new study that was presented at the American Physiology Summit in Long Beach, California.

Using mice as subjects, researchers administered water containing an acetaminophen dosage equivalent to 500 milligrams per day in adult humans. After seven days, significant changes were observed in the levels of proteins associated with various biochemical pathways crucial for heart function, including energy production, antioxidant usage, and the breakdown of damaged proteins.

The results suggest that even at concentrations typically considered safe for human use, acetaminophen can disrupt numerous signaling pathways within the heart.

“We expected two to three pathways to be altered, but we found over 20 different signaling pathways being affected,” Gabriela Rivera, a doctoral student at the University of California–Davis and the study’s lead author, said in a press release.

Immunologist and Biochemist Speaks out About Dangers of Acetaminophen for Children

Acetaminophen had been previously thought to carry a low risk of harmful side effects even when used as directed. This study helps with understanding its effects, which already include a risk of gastrointestinal problems, increased blood pressure, and liver toxicity (when used in large doses).

Prolonged High-Dose Use May Tax Body’s Detox Systems

The findings suggest that prolonged medium- to high-dose usage of acetaminophen could lead to heart issues due to oxidative stress or the accumulation of toxins produced during the breakdown of the medication, potentially overwhelming the body’s detoxification mechanisms.

The observed changes suggest that the hearts of mice treated with acetaminophen had increased stress and mitochondrial dysfunction, Ms. Rivera told The Epoch Times.

The findings highlight the importance of dosage and duration of use; long-term use at medium to high doses may pose greater risks than occasional or low-dose consumption.

The study used a “global proteomic approach,” which enabled the research team to observe the alterations in proteins inside the heart impartially, Ms. Rivera said. “Studies were also conducted on cardiac cells, which complement the proteomic studies,” she added.

A limitation of this experiment is that it was conducted in female mice only, so findings may not apply to the effects of regular acetaminophen usage in male mice or humans.

Acetaminophen Currently Considered Safe: Expert

Acetaminophen is a commonly used drug considered safe at low to moderate dosages of 660 to 1,000 milligrams every four to six hours.

There are no known cardiovascular risks associated with acetaminophen use based on current evidence, Dr. Samantha Lee, director of cardiac telemetry at Staten Island University Hospital, told The Epoch Times.

“A healthy adult can take a lot more acetaminophen than you might expect—up to 4,000 milligrams per day,” she said, though cautioning that an overdose can lead to liver injury.

Daily acetaminophen use could cause rebound headaches, known as medication overuse headaches, treatable by stopping the pain reliever, Dr. Lee noted.

When recommending pain relief for headaches and joint pains, Dr. Lee said she prefers acetaminophen over nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, which increase clot formation, blood pressure, and fluid retention, worsening cardiovascular outcomes.

“While this study shows acetaminophen may affect the signaling pathways in the heart of mice models, it does not prove any harmful cardiac side effects in humans,” Dr. Lee said, adding that, like arthritis, cardiac conditions are more common with age, so doctors need pain relief recommendations. “For me, that recommendation is still acetaminophen,” she said.

Acetaminophen Use in Pregnancy Linked to ADHD in Kids

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Summary: Researchers found a connection between the increased use of acetaminophen during pregnancy, particularly in the second trimester, and attention and behavior problems in young children. The research, part of the Illinois Kids Development Study, involved tracking prenatal chemical exposures and assessing the behaviors and traits of children at ages 2, 3, and 4.

While acetaminophen is deemed the safest painkiller during pregnancy, the study reveals a trend where higher usage, especially in the second trimester, corresponds to more attention-related problems and ADHD-type behaviors in children. However, the study’s authors emphasize the need for more research and caution against interpreting the findings as an indication of ADHD or other disorders.

Key Facts:

  1. The study links frequent acetaminophen use in pregnancy, especially in the second trimester, to attention problems in children.
  2. Over 300 children were assessed, showing a trend of more attention-related and externalizing behaviors with increased acetaminophen exposure.
  3. This research adds to existing concerns about acetaminophen’s impact on child development, yet more studies are needed for conclusive evidence.

Source: University of Illinois

A new study links increased use of acetaminophen during pregnancy – particularly in the second trimester – to modest but noticeable increases in problems with attention and behavior in 2-, 3- and 4-year-olds.

The study adds to a growing body of evidence linking the frequent use of acetaminophen in pregnancy to developmental problems in offspring.

The findings are detailed in the journal Neurotoxicology and Teratology.

This shows a pregnant woman.
The researchers also asked caregivers to answer dozens of standardized questions about their child’s behavior and ability to pay attention at ages 2, 3 and 4.

The research is part of the Illinois Kids Development Study at the University of Illinois Urbana-Champaign, which explores how environmental exposures influence child development. The study tracked hundreds of children, collecting data on their prenatal chemical exposures and asking caregivers to assess their behaviors and traits at ages 2, 3 and 4.

While acetaminophen is considered the safest painkiller and fever reducer available during pregnancy, previous studies have found evidence of a range of possible negative outcomes for children exposed to the drug in gestation, said Megan Woodbury, who led the research as a graduate student at the U. of I. with comparative biosciences professor emerita Susan Schantz, the principal investigator of the IKIDS program at Illinois. Woodbury is now a postdoctoral researcher at Northeastern University in Boston. Schantz is a faculty member of the Beckman Institute for Advanced Science and Technology at the U. of I.

A recent study led by Woodbury and Schantz linked higher acetaminophen exposure in pregnancy to language delays in children.

Some previous studies have found no relationship between acetaminophen use in pregnancy and attention and behavior in childhood, while other, usually larger studies found relationships between more frequent use of the medication during pregnancy and attention-related and behavioral problems in offspring.

Most of the latter studies were conducted in older children and questioned pregnant participants about their use of acetaminophen at most once per trimester.

The new study asked pregnant parents about their acetaminophen use six times over the course of the pregnancy – roughly once every four-to-six weeks – offering a more precise picture of the magnitude and timing of the drug exposures.

The researchers also asked caregivers to answer dozens of standardized questions about their child’s behavior and ability to pay attention at ages 2, 3 and 4. More than 300 children were assessed at age 2, with 262 assessed again at 3, and 196 at age 4.

“Our most important finding was that with increasing acetaminophen use by pregnant participants, especially during the second trimester, their children showed more attention-related problems and ADHD-type behaviors, which we call ‘externalizing behaviors,’ at every age we measured,” Woodbury said.

“The kinds of behaviors the caregivers reported included things like the child talking out of turn, not paying attention, not being quiet when they were supposed to be quiet, not sitting down when they were supposed to be sitting down, and being a little aggressive with other children,” Schantz said.

The findings are not an indication that the children have attention-deficit/hyperactivity disorder or that they will be diagnosed with ADHD at a later date, Schantz said. But the children seem to be having more trouble with attention than peers of the same age who were less exposed or not exposed to acetaminophen in the womb.

Woodbury, who herself is pregnant, says she does not want to scare others away from using acetaminophen in pregnancy when needed. Extreme headaches or other painful episodes and fevers can be debilitating and even dangerous, calling for use of the drug. She said she has turned to acetaminophen once per trimester so far. But she also chooses not to use it for minor aches, pains or slight fevers.

More research is needed to test whether more frequent use of acetaminophen during the second trimester of pregnancy may be particularly problematic for the developing brain, the researchers said.

The study also is limited as participants were mostly white, non-Hispanic and of higher economic status. Schantz and her team are working to broaden the cohort of participants in IKIDS to include pregnant people from a greater diversity of social, economic and racial backgrounds.

Funding: This research was supported by the Children’s Environmental Health and Disease Prevention Research Center funded by the National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency and the National Institutes of Health Environmental Influences on Child Health Outcomes program.

Abstract

The relationship of prenatal acetaminophen exposure and attention-related behavior in early childhood

Acetaminophen is currently the only analgesic considered safe for use throughout pregnancy, but recent studies indicate that prenatal exposure to acetaminophen may be related to poorer neurodevelopmental outcomes. Multiple studies have suggested that it may be associated with attention problems, but few have examined this association by trimester of exposure.

The Illinois Kids Development Study is a prospective birth cohort located in east-central Illinois. Exposure data were collected between December 2013 and March 2020, and 535 newborns were enrolled during that period. Mothers reported the number of times they took acetaminophen at six time points across pregnancy.

When children were 2, 3, and 4 years of age, caregivers completed the Child Behavior Checklist for ages 1.5–5 years (CBCL). Associations of acetaminophen use during pregnancy with scores on the Attention Problems and ADHD Problems syndrome scales, the Internalizing and Externalizing Behavior composite scales, and the Total Problems score were evaluated.

Higher acetaminophen exposure during the second trimester of fetal development was associated with higher Attention Problems, ADHD Problems, Externalizing Behavior, and Total Problems scores at ages 2 and 3. Higher second trimester exposure was only associated with higher Externalizing Behavior and Total Problems scores at 4 years.

Higher cumulative exposure across pregnancy was associated with higher Attention Problems and ADHD Problems scores at ages 2 and 3. Findings suggest that prenatal acetaminophen exposure, especially during the second trimester, may be related to problems with attention in early childhood.

Taking acetaminophen (Tylenol) while pregnant linked to ADHD symptoms in preschoolers

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 It’s no secret that pregnant women should avoid alcohol and cigarettes for the health of their baby. Some pregnancy symptoms such as back pain or headaches may make mothers want to take a Tylenol. Now, researchers from Penn State say it may be a good idea to stay away from Tylenol as well. Study authors report taking acetaminophen while expecting may lead to sleep and behavioral issues in children that are consistent with attention deficit hyperactivity disorder (ADHD).

Sold under a number of different names, acetaminophen is generally a mild drug which treats pain, fever, headaches, infections, colds, or allergies. Historically, doctors have considered the drug safe to take while pregnant for quite some time. Recent research, however, is starting to suggest that acetaminophen may affect child development and may have a connection to attention problems.

This latest research project appears to support those earlier preliminary findings. Study authors say their work is the first ever to observe a clear association between acetaminophen use while pregnant and subsequent child sleep challenges.

“Pregnant people experience pain, fever and other ailments that could be alleviated through the use of acetaminophen,” says lead study author Kristin Sznajder, an assistant professor of public health sciences, in a university release. “While the medication may provide relief in the moment, research increasingly indicates there may be downstream effects that could be detrimental to child development. More research is needed so appropriate recommendations can be made to pregnant people.”

4 in 10 pregnant women use mild pain relievers

The researcher team utilized data originally collected for a study of over 2,400 pregnant women who had never given birth. That prior study tracked those women and their children from the third trimester of pregnancy to three years postpartum. Participants completed surveys while pregnant regarding their medication use and frequency and stress levels. In all, 41.7 percent of women reported using acetaminophen during pregnancy.

Next, researchers interviewed the mothers multiple times after giving birth — one, six, 12, 18, 24, 30, and 36 months after their child was born. During the last interview, participants had to rate their child using a three-point scale describing how often they exhibit various neurodevelopmental and behavioral outcomes (very often true, somewhat or sometimes true, or not true). Examples include “can’t sit still or restless,” “avoids looking others in the eyes,” and “doesn’t want to sleep alone.” Scientists then combined the scores for each behavior to help determine if each child scored high in categories such as emotionally reactive, anxious or depressed, withdrawn, sleep problems, and aggressive behavior.

Using responses from the 99-item Child Behavior Checklist, the research team then evaluated if children born to mothers who used acetaminophen during pregnancy were more likely to have attention, sleep, or other neurobehavioral issues. Since women who used acetaminophen while pregnant were more likely to deal with depression or anxiety before becoming pregnant and were also more likely to report high levels of stress during pregnancy, researchers decided to account for stress, depression during pregnancy, and previous diagnoses of depression or anxiety during their statistical analyses.

Even after accounting for those confounding variables, children born to women who used acetaminophen were still significantly more likely to deal with sleep issues and attention problems than other children. More specifically, 22.7 percent of participants who used acetaminophen while pregnant said their child had sleep issues. Another 32.9 percent described their children as having attention problems. Conversely, among women who did not take acetaminophen while pregnant, only 18.9 percent said their child had trouble sleeping and 28 percent noticed attention problems.

Could pregnancy trimester be a factor?

Study authors say more research is necessary to totally understand the relationship between acetaminophen use while pregnant and behavioral outcomes among offspring. For instance, survey responses used for this project lacked data on the trimester of use, frequency of use, and dosage amount. Prof. Sznajder notes another study is already underway focusing on how the trimester, frequency, and dosage may influence behavioral offspring outcomes.

Right now, the research team can’t say what prenatal development processes prenatal acetaminophen use may be disrupting. However, a few possibilities include acetaminophen damaging the placenta, consequently disrupting fetal development, or acetaminophen damaging fetal liver cells, disrupting gut health, and influencing neurodevelopment.

“We should interpret these results with some degree of caution,” Prof. Sznajder concludes. “Although acetaminophen is generally considered safe for use during pregnancy, data from multiple studies suggest that there could be effects on childhood development by its use. It’s important we learn as much as we can about this subject so we can give expecting mothers data-driven recommendations to care for their children and themselves.”

Taking acetaminophen (Tylenol) while pregnant linked to language delays in children

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 Pregnant women should think twice before taking Tylenol, a new study warns. Researchers from the University of Illinois Urbana-Champaign find that using acetaminophen, a common over-the-counter pain reliever and fever reducer, during pregnancy could possibly lead to language development delays in early childhood.

Acetaminophen, better known by the brand name Tylenol, is widely regarded as the safest pain relief option during pregnancy. Between 50 and 65 percent of women in North America and Europe use the drug.

The study builds upon previous research that associated acetaminophen use during pregnancy with poorer child communication skills. However, this new study employed more precise methods of measuring language development.

Pregnant woman showing her bump

“The previous studies had only asked pregnant people at most once a trimester about their acetaminophen use,” says study author Megan Woodbury, who conducted the research as a graduate student at the University of Illinois Urbana-Champaign, in a university release. “But with IKIDS, we talked to our participants every four to six weeks during pregnancy and then within 24 hours of the kid’s birth, so we had six time points during pregnancy.”

Researchers engaged with participants regularly throughout their pregnancy and shortly after birth, providing a detailed timeline of acetaminophen use. They focused on language development in children at ages two and three, utilizing the MacArthur-Bates Communicative Development Inventories for assessing vocabulary, language complexity, and the length of children’s utterances.

Common OTC painkillers and pain medicine

The study found that increased acetaminophen use, particularly during the third trimester, correlated with lower vocabulary scores and shorter average utterance lengths in two-year-olds. At age three, greater use during the third trimester was linked to parents perceiving their children’s language abilities as lower than their peers, especially in male children. One notable result was that each instance of acetaminophen use in the third trimester was associated with an almost two-word reduction in vocabulary in two-year-olds.

“This suggests that if a pregnant person took acetaminophen 13 times – or once per week – during the third trimester of that pregnancy, their child might express 26 fewer words at age 2 than other children that age,” notes Woodbury, now a postdoctoral researcher at Northeastern University in Boston.

Researchers stress the importance of this period for fetal brain development, noting the critical development of hearing in the second trimester and the initiation of language development in the third trimester.

“It’s thought that acetaminophen exerts its analgesic effect through the endocannabinoid system, which is also very important for fetal development,” explains Woodbury.

A mother holding a crying toddler
A mother holding a crying toddler

Despite these findings, researchers caution against outright avoidance of acetaminophen during pregnancy, especially when needed for serious pain or high fever, as conditions like very high fever can be dangerous.

“There aren’t other options for people to take when they really need them,” says Susan Schantz, professor emerita of comparative biosciences at University of Illinois Urbana-Champaign and IKIDS principal investigator. “But perhaps people should use more caution when turning to the drug to treat minor aches and pains.”

Language Delays Linked to Acetaminophen Use During Pregnancy

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Summary: A new study reveals a potential link between acetaminophen use during pregnancy and language delays in early childhood.

The research involved continuous monitoring of pregnant women’s acetaminophen use and precise language development assessments in their children at ages 2 and 3. Increased acetaminophen use, especially during the third trimester, was associated with smaller vocabularies and shorter utterances in 2-year-olds.

Each use of acetaminophen in the third trimester was linked to a two-word reduction in vocabulary in 2-year-olds, raising concerns about its impact on fetal brain development.

Key Facts:

  1. The study tracked acetaminophen use throughout pregnancy and assessed language development in children at ages 2 and 3.
  2. Increased acetaminophen use during the third trimester was associated with significant language delays in 2-year-olds, especially in males.
  3. Fetal brain development, particularly language development, occurs during the second and third trimesters, making this period critical for potential impacts.

Source: University of Illinois

Acetaminophen is considered the safest over-the-counter pain reliever and fever reducer available during pregnancy. Studies have shown that 50%-65% of women in North America and Europe take acetaminophen during pregnancy.

A new study from researchers at the University of Illinois Urbana-Champaign explored the relationship between acetaminophen use during pregnancy and language outcomes in early childhood. It found that increasing acetaminophen use was associated with language delays.

This shows a pregnant woman.
The findings need to be tested in larger studies, the researchers said. Until then, people should not be afraid to take acetaminophen for fever or serious pain and discomfort during pregnancy. Credit: Neuroscience News

The findings are reported in the journal Pediatric Research.

Earlier studies have found associations between acetaminophen use during pregnancy and poorer child communication skills. But those studies used measures of language development that were less precise than the methods applied in the current study, said Megan Woodbury, who led the research as a graduate student with U. of I. comparative biosciences professor emerita Susan Schantz.

The work was conducted as part of the Illinois Kids Development Study, which explores how environmental exposures in pregnancy and childhood influence child development. Schantz is the IKIDS principal investigator. Woodbury is now a postdoctoral researcher at Northeastern University in Boston.

“The previous studies had only asked pregnant people at most once a trimester about their acetaminophen use,” Woodbury said. “But with IKIDS, we talked to our participants every four to six weeks during pregnancy and then within 24 hours of the kid’s birth, so we had six time points during pregnancy.”

The language analyses involved 298 2-year-old children who had been followed prenatally, 254 of whom returned for further study at age 3. 

For the 2-year-olds, the researchers turned to the MacArthur-Bates Communicative Development Inventories, which asks a parent to report on the child’s vocabulary, language complexity and the average length of the child’s longest three utterances.

“We wanted to collect data at that age because it’s the period called ‘word explosion,’ when kids are just adding words every day to their vocabulary,” Schantz said.

The vocabulary measure asked parents to select words their child had used from a list of 680 words.

The parents assessed their child again at 3 years, comparing their language skills to those of their peers.

The analysis linked acetaminophen use in the second and third trimesters of pregnancy to modest but significant delays in early language development.

“We found that increased use of acetaminophen – especially during the third trimester – was associated with smaller vocabulary scores and shorter ‘mean length of utterance’ at two years,” Woodbury said.

“At age three, greater acetaminophen use during the third trimester was related to parents ranking their kids as lower than their peers on their language abilities,” Schantz said. “That outcome was seen primarily in male children.”

The most dramatic finding was that each use of acetaminophen in the third trimester of pregnancy was associated with an almost two-word reduction in vocabulary in the 2-year-olds.

“This suggests that if a pregnant person took acetaminophen 13 times – or once per week – during the third trimester of that pregnancy, their child might express 26 fewer words at age 2 than other children that age,” Woodbury said.

Fetal brain development occurs throughout pregnancy, but the second and third trimesters are especially critical times, Schantz said.

“Hearing is developing in the second trimester, but language development is already starting in the third trimester before the baby is even born,” she said.

“It’s thought that acetaminophen exerts its analgesic effect through the endocannabinoid system, which is also very important for fetal development,” Woodbury said.

The findings need to be tested in larger studies, the researchers said. Until then, people should not be afraid to take acetaminophen for fever or serious pain and discomfort during pregnancy. Conditions like a very high fever can be dangerous and using a drug like acetaminophen will likely help.

“There aren’t other options for people to take when they really need them,” Schantz said. “But perhaps people should use more caution when turning to the drug to treat minor aches and pains.”

Pregnant Acetaminophen Users Risk ADHD in Offspring

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Pregnant Acetaminophen Users Risk ADHD in Offspring

Acetaminophen (the active ingredient in Tylenol and Excedrin) is the most common over-the-counter pain medication. A new, long-term study found that pregnant women who take the drug may be placing their unborn children at risk of developing attention deficit disorders.

In the report, “Acetaminophen Use During Pregnancy, Behavioral Problems, and Hyperkinetic Disorders,” published in JAMA Pediatrics, researchers found a compelling pattern of pregnant mothers taking acetaminophen and offspring who are later diagnosed with attention deficit hyperactivity disorder (ADHD), exhibiting ADHD-like behaviors, or taking ADHD medication.

Researchers looked at data on 64,322 children and mothers who were enrolled in a Danish study tracking pregnancies and children, from 1996 to 2002.

A series of computer-assisted telephone interviews taken throughout each pregnancy found that more than one-half of all the mothers reported using acetaminophen. Researchers discovered that children born to mothers taking the medication had up to a 37 percent higher risk of ADHD by age seven.

Mothers who continued to take acetaminophen into the second and third trimesters had the strongest associations with ADHD. According to the report, risks were elevated by 50 percent or more when the mothers used the painkiller for more than 20 weeks into their pregnancy.

According to the National Institutes of Health, ADHD is one of the most common childhood disorders. Symptoms include difficulty staying focused and uncontrollable hyperactive behavior.

The jury is still out about what causes ADHD—and why there are now so many cases. Some doctors insist that the epidemic is merely the result of better diagnosing, while others point to various environmental and genetic factors.

According Dr. Beate Ritz, professor and vice chair of the Epidemiology Department at the University of California, Los Angeles’ (UCLA) School of Public Health and one of the senior authors of the report, the impetus for the study was the drug’s emerging reputation as a hormonal disrupter.

“We know ADHD has to do with the balance of certain brain circuitry and systems that are interacting with each other,” she said. “If we disturb that, we could see how that would lead to some kind of neurodevelopmental disorder or shift.”

The preponderance of ADHD in boys, and general fetal sensitivity to hormonal changes, got researchers thinking about how a widely used hormonal disrupter might affect a developing fetus. Ritz’s colleague, Dr. Jørn Olsen, another senior author and chair of the UCLA Epidemiology Department, has seen previous patterns of fetal hormonal disturbance, with pregnant women and acetaminophen use showing a greater risk for children with undescended testicles.

Safety Reputation

In the 1950s, acetaminophen was a new over-the-counter alternative to remedy pain and headaches, but over the years it has come to dominate the market—not only due to its effectiveness but also its reputation for safety. Since the 1970s, doctors have favored the well-tolerated acetaminophen over aspirin or other painkillers, particularly for pregnant women.

While it may be the safest analgesic in the modern medical arsenal, acetaminophen still carries significant risks that some say require more caution.

In September 2013, ProPublica and NPR collaborated on a report on acetaminophen and found that for more than 30 years, the U.S. Food and Drug Administration (FDA) had either “delayed or failed to adopt measures designed to reduce deaths and injuries” related to the drug.

In that report, the big issue was dosage, which the FDA found to be a “persistent, important public health problem.” While relatively safe at recommended doses, even slight overdoses have been shown to cause liver damage, resulting in about 150 deaths a year, according to the Centers for Disease Control.

Fetal Vulnerability

The FDA recently announced that it will review its over-the-counter drug policy. However, the safety issue becomes even more complicated in regard to acetaminophen as a hormonal disrupter—where even relatively small doses may have a profound effect on the body’s endocrine system, especially in the midst of development.

“We know that during development the fetus actually prepares itself for the environment he or she may encounter after being born,” said Ritz. “That’s very true with nutrition, but there are also certain chemicals, stress hormones that the mother has in her body that can program the brain.”

Instead of traditional measures of toxicity where a high enough dose threshold triggers damage to cells, endocrine disruptive chemicals can interfere in delicate hormonal processes with doses previously considered benign. As a young life builds fine details of its neurological system toward the later stages of fetal development, the body can be particularly vulnerable to a chemical influence disrupting the process, according to Ritz.

“That can happen at much lower doses than what we would normally expect for toxicity,” said Ritz.

UCLA researchers want to see more tests with variations in the study design to see if the pattern holds up. But until that’s available in another decade or so, Ritz urges caution to pregnant mothers.

“I would want to be careful,” she said, adopting a pregnant mother’s perspective. “‘I had to deal with my headache in a different way, but at least I didn’t put my fetus at risk.’”

Surprising Side Effects of Tylenol

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Extra Strength Tylenol is displayed in a drugstore in Washington, on July 5, 2006. (Brendan Smialowski/Getty Images)

Extra Strength Tylenol is displayed in a drugstore in Washington, on July 5, 2006.

You know Tylenol can relieve a headache, but are you aware it can cause other side effects, such as increased risk of death or heart toxicity?

Have you ever popped a Tylenol to push through that annoying headache and get on with your day? Most of us have. Each week, millions of Americans take one of the 600 medicines that contain acetaminophen, Tylenol’s active ingredient, for various aches and pains. Acetaminophen is the most common drug ingredient in the US, but this ‘harmless drug’ is linked to over 110,000 injuries and deaths per year.

How can Tylenol, which is doled out like candy, be bad for you? Amazingly, no one really knows how acetaminophen works, but people do know that this drug gets to your brain. Tylenol in your brain is concerning because it depletes glutathione, an antioxidant that is especially necessary for brain health. Our bodies depend on antioxidants to balance oxidative damage and inflammation. If you’re popping a Tylenol with your morning antioxidant-rich smoothie, Tylenol may rob you of the smoothie’s benefits!

(Niloo/Shutterstock)

Beyond Liver Damage

Most people have heard that Tylenol can damage the liver (has anyone ever drunkenly warned you to take a Motrin, not a Tylenol, to prevent a hangover?). But since everything in our bodies is connected, it’s not surprising that Tylenol can do damage beyond your liver. A recent study showed that people who took Tylenol had increased risks of death, heart toxicity, gastrointestinal bleeding, and kidney damage. Importantly, people who took more Tylenol suffered more damage.

It’s also scary how Tylenol affects mood. After swallowing 1000 mg of Tylenol, people exhibited less empathy and blunted positive emotions. For reference, 1000 mg is two extra-strength Tylenol tablets, and the ‘safe’ range is 3000 mg per day. This means that popping two Tylenols can affect you physically and emotionally!

If you’re pregnant or looking to become pregnant, please be especially careful about taking Tylenol. Research has shown that children exposed to acetaminophen in the womb had behavioral, communication, and motor skill problems. Another study linked prenatal acetaminophen exposure with increased ADHD-like behaviors and medication use.

What About Other Painkillers?

Hopefully you’re convinced to think twice before taking a Tylenol, but what about other pain-relievers like Motrin, Aleve, or Advil? These non-steroidal anti-inflammatory drugs (NSAIDs) must be safe, since thirty million people take them every day! Not so fast…

Women who recognize the importance of hormonal balance should be wary. NSAIDs can mess with ovulation, especially progesterone levels, after only 10 days of use. Additionally, NSAIDs injure the small intestine; in one study, 71% of NSAID users showed small intestinal damage, compared to 10% of non-users [5]. Damaged intestines can lead to intestinal permeability, or “leaky gut.” Leaky gut has been linked to depression, ADHD, and allergies.  NSAIDs can cause leaky gut and harm your microbiome, the trillions of beneficial bacteria that live in and on us. Disrupting our bacteria can do more damage than we realize!

How Can I Relieve My Headache?!

Now that you know the surprising dangers of Tylenol and other NSAIDs, what should you take for headaches and other aches and pains? Turmeric, the yellow root found in curry powder, contains a powerful anti-inflammatory and pain reliever called curcumin. This has been used in Ayurvedic and Chinese medicine as a treatment for pain, digestive disorders, and wound healing for centuries. Many studies show the beneficial effects of curcumin; curcumin works as well as ibuprofen to alleviate pain from knee osteoarthritis and PMS. Next time you have a headache, try 1-2 grams of curcumin – or a turmeric latte!

What is the role of Ibuprofen and Acetaminophen in migraine management?

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Acetaminophen (Paracetamol) and non-steroidal anti-inflammatory drugs (NSAID) like Ibuprofen have been shown to effectively relieve migraine pain. The commonly used dosage of these drugs to treat migraine are as follows:

DrugDose (adults)Maximum daily dosage (adults)
Ibuprofen400 mg2400 mg
Acetaminophen1000 mg4000 mg[1]

In children and teenagers, Ibuprofen and Acetaminophen can be administered. For children aged 12 years and above, Acetaminophen also in combination with Metoclopramide can be used.[1]

Ibuprofen: 

  • It is rapidly absorbed by the gastrointestinal tract
  • Rapid onset of action
  • In comparison to the tablet formulation, the solubilised liquid-containing capsules show a faster onset of action and a superior response rate for headache relief at 1 hour.
  • Short half-life (2 hours) and thus multiple doses are required. 
  • Higher doses are not more effective than the standard 400-mg dose.
  • Less gastric irritation.[2]

Acetaminophen (mild or moderate migraine attack):

  • For acute migraine headaches, Paracetamol 1000 mg alone is helpful, and the addition of 10 mg Metoclopramide provides short-term efficacy.
  • Acetaminophen causes fewer gastric side effects
  • Does not affect platelet function
  • Short half-life of 2-3 hours and thus multiple doses are required.
  • To minimise hepatotoxic side effects, the total daily dose should not exceed 4000 mg.

Acetaminophen can also be used with other medications. When given in comparable doses, the combination of Aspirin, Paracetamol, and caffeine has been shown to be more effective. To avoid the medication-overuse headache, Acetaminophen or NSAIDs should be used for not more than 14 days per month when used alone; the use of a combination of these drugs should be limited to 10 days a month.

MedicationFormulationTmax (h)Elimination half-life (h)Usual dose (mg)Dosage intervalMaximum daily dose (mg/day)
IbuprofenOral tablets1-224004 h2400
 solubilised liquid-containing capsules<124004 h2400
AcetaminophenOral tablets0.5-1210004 h4000