Tylenol and Autism link?

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A new study out of Spain has uncovered what it calls a potential link between pregnant women using the drug acetaminophen — which many people know by the brand name Tylenol — and then their child developing autism or attention-deficit/hyperactivity disorder (ADHD).

Researchers from the University of Barcelona studied health data from more than 73,000 mother-child pairs across Europe. They found that unborn children exposed to acetaminophen were 19% more likely to be on the autism spectrum and 21% more likely to show signs of ADHD.

The researchers did warn that this study is just a possible link. Readers should not take their findings as definitive proof.

FULL QUESTION
Does Tylenol have links to Autism?

Is Tylenol a threat for pregnant people and tied to asd [autism] and adhd?

FULL ANSWER
Readers have asked whether Tylenol (acetaminophen) is connected to autism or ADHD, also known as attention-deficit/hyperactivity disorder. One person forwarded a sponsored Facebook post from the page “Child Autism & ADHD from Tylenol during pregnancy” stating that “parents of children with autism or ADHD whose mother took Tylenol while pregnant may be eligible for legal compensation.” The page continues to run similar advertisements, as do various other pages. Parents have filed lawsuits against retailers of acetaminophen, stating that their children developed autism or ADHD due to exposure to acetaminophen taken during pregnancy.

Some studies have indeed shown a relationship between acetaminophen taken during pregnancy and autism or ADHD in children, but they do not demonstrate that the acetaminophen use caused the elevated rates of autism and ADHD, researchers say. For example, a pregnant person who takes acetaminophen may have a child with ADHD or autism because of other factors, such as genetics.

Experts agree that acetaminophen has a role in pregnancy but that it should be used only when necessary and in consultation with a doctor. Avoiding use of acetaminophen for fever or pain during pregnancy may have negative consequences. For instance, an uncontrolled fever in early pregnancy can harm brain development.

A Food and Drug Administration spokesperson told us via email that the available evidence is “too limited to make any recommendations based on these studies at this time.”

The American College of Obstetricians and Gynecologists said in a 2021 statement that studies “show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and fetal developmental issues.” An ACOG representative told us that the statement is the most up-to-date communication on the topic. And a 2017 Society for Maternal-Fetal Medicine statement, which a representative also confirmed to be the most up-to-date document, found the evidence on a causal link between acetaminophen and neurobehavioral disorders to be “inconclusive.”

Studies of Acetaminophen During Pregnancy Have Weaknesses
Acetaminophen, called paracetamol outside the U.S., is used widely during pregnancy to treat pain and fever. It is an ingredient in many over-the-counter and prescription medications, including Tylenol, DayQuil, NyQuil, Excedrin, Sudafed, Mucinex, Midol, oxycodone, Vicodin and others.

As we said, some studies have found that women who reported using acetaminophen during pregnancy were more likely than those who didn’t to have children who later developed autism or ADHD. A 2018 paper published in the American Journal of Epidemiology that aimed to comprehensively analyze data from multiple studies, for example, found a 34% and 19% higher risk of ADHD and autism, respectively, in children whose mothers took acetaminophen in pregnancy compared with those whose mothers did not.

But this doesn’t necessarily mean acetaminophen is to blame for the conditions. These studies were observational, meaning that researchers simply noted levels of acetaminophen exposure, generally based on reports from the parents in the studies. Randomized controlled trials — in which one group receives a medication or treatment and another group receives a placebo or standard care — are the gold standard for determining whether a causal relationship exists.

It is possible that people who take more acetaminophen are more likely to have characteristics that predispose them to have a child with autism or ADHD — including the illnesses or other health conditions that might have prompted a pregnant person to take acetaminophen in the first place.

The authors of the 2018 study recognized this issue, writing that the results “should be interpreted with caution given that the available evidence consists of observational studies and is susceptible to several potential sources of bias.”

Sura Alwan, a birth defects epidemiologist and co-director of the Teratogen Information System at the University of Washington, told us in an email that genetic factors might also help explain the results, adding that not all studies have found an association between prenatal acetaminophen and neurodevelopmental outcomes like autism and ADHD.

In any case, she said, the studies “do not necessarily imply a causal link, which means that there isn’t enough evidence to say that taking acetaminophen causes those behavioral or cognitive concerns.”

Some researchers do think the associations are worrisome enough to caution women taking acetaminophen during pregnancy. In 2021, an international group of scientists, clinicians, and public health professionals published what they called a “consensus statement” in Nature Reviews Endocrinology, which made news for calling for “precautionary action” based on data indicating acetaminophen might alter fetal development, with an increasing impact with increasing duration of exposure.

“We recognize that limited medical alternatives exist to treat pain and fever; however, we believe the combined weight of animal and human scientific evidence is strong enough for pregnant women to be cautioned by health professionals against its indiscriminate use, both as a single ingredient and in combination with other medications,” the researchers wrote.

The statement proved controversial, however, with other groups of scientists pushing back to add context and explain why acetaminophen might not have caused the links seen in the studies.

“In my opinion, the level of evidence out there is poor, and I do not believe that there is any causal or any other association between at least short-term use of acetaminophen during pregnancy and ensuing increased risk of childhood ADHD or ASD [autism],” Dr. Per Damkier, a professor and clinical pharmacologist at Odense University Hospital and University of Southern Denmark, told us in an interview. Damkier was one of the scientists who pushed back at the consensus statement.

Multiple factors contribute to autism and ADHD. These conditions “are variable in clinical presentation, very difficult to assess and associate with a single causal factor,” Alwan said.

Damkier emphasized that many studies do not adequately take into account whether the parents had ADHD or autism, which run in families. He pointed to one study that suggested accounting for ADHD in parents likely weakens the relationship between this disorder and acetaminophen.

Many studies also rely on questionnaires filled out by parents, Damkier said. These may identify children at increased risk of ADHD or autism but do not replace an official diagnosis.

Finally, Damkier said that even if you accepted the analyses in the studies showing increased risk as valid, “which you should not,” the risk levels — typically 20% to 30% increased risk during childhood — represent a “weak association,” especially since there is typically a fair to moderate degree of uncertainty surrounding the numbers.

A Closer Look at Cord Blood
A 2019 JAMA Psychiatry study, which is cited in legal advertisements, did not rely on self-reported data, instead looking at concentrations of broken down acetaminophen components in blood collected at Boston Medical Center from umbilical cords at birth and stored for future study.

The children with acetaminophen exposure in the top third — meaning the highest concentrations of the drug components in cord blood — had 2.86 times higher odds of an ADHD diagnosis and 3.62 times higher odds of an autism diagnosis compared with children with exposure in the bottom third. “Our findings support previous studies regarding the association between prenatal and perinatal acetaminophen exposure and childhood neurodevelopmental risk and warrant additional investigations,” the authors wrote.

The authors themselves noted some limitations of the paper at the time of publication. The cord blood measurements did not give a sense of acetaminophen exposure throughout pregnancy, instead showing recent use by people who had just given birth. Further, “caution is needed to apply our findings to other populations with different characteristics,” they wrote. Finally, one author pointed out in a press release that the study does not show that Tylenol causes ADHD or autism.

Damkier and others said that some observations and the characteristics of the children in the study appeared unusual, making it hard to draw general conclusions. Every cord blood sample showed acetaminophen exposure, he noted, and there were extremely high rates of ADHD and autism among the children. The study also lacked information on the mothers’ use of drugs or history of psychiatric disease.

[b%]Acetaminophen Treats Pain and Fever During Pregnancy[/b]
Expert groups said that acetaminophen can have benefits for pregnant people experiencing pain or fever, and there may not be good alternatives. The ACOG statement reads: “ACOG and obstetrician-gynecologists across the country have always identified acetaminophen as one of the only safe pain relievers for pregnant individuals during pregnancy.”

Nonsteroidal anti-inflammatory drugs, such as ibuprofen and aspirin, can have risks during pregnancy. Taking these drugs during later portions of pregnancy can lead to problems including insufficient amniotic fluid volume and premature closing of a major blood vessel in the fetus. Opioids can also harm the fetus and lead to withdrawal at birth, as well as pose risks for the mother.

Avoiding acetaminophen could have consequences for both mother and child. Fever early in pregnancy can lead to defects in the neural tube affecting the formation of the brain or spinal cord, Alwan said, noting that it is “critically important to treat fever in pregnancy.”

The Society for Maternal-Fetal Medicine statement calls acetaminophen “a reasonable and appropriate medication choice for the treatment of pain and/or fever during pregnancy.”

The authors of the 2021 Nature Reviews Endocrinology statement suggested doing more research into acetaminophen during pregnancy and cautioned women to “forego APAP [acetaminophen] unless its use is medically indicated; consult with a physician or pharmacist if they are uncertain whether use is indicated and before using on a long-term basis; and minimize exposure by using the lowest effective dose for the shortest possible time.”

This advice is in line with longstanding recommendations for pregnant people. “ACOG’s clinical guidance remains the same and physicians should not change clinical practice until definitive prospective research is done. Most importantly, patients should not be frightened away from the many benefits of acetaminophen. However, as always, any medication taken during pregnancy should be used only as needed, in moderation, and after the pregnant patient has consulted with their doctor,” the ACOG statement said.

“It is important for pregnant women and all women of reproductive age who may become pregnant to always consult their health care provider to find the best treatment option for pain or fever in pregnancy, which may be taking the recommended dose of acetaminophen and making sure to stay well hydrated and getting lots of rest,” Alwan said. People with questions about medications during pregnancy or breastfeeding can contact organizations like MotherToBaby, she added.

An FDA spokesperson told us in an email: “The FDA is aware of and understands the concerns arising from reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, we evaluated research studies on acetaminophen published in the medical literature and determined that they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. We urge pregnant persons to always discuss all medicines with their health care professionals before using them. Acetaminophen labels contain the following information regarding pregnancy: ‘If pregnant or breast feeding, ask a health professional before use.’ The FDA continues to review the published literature and to monitor the potential impacts of acetaminophen.”

The spokesperson concluded by sharing a link to a 2015 Drug Safety Communication describing an FDA review of the risks of pain medicine during pregnancy. The document noted that severe and persistent pain, when not treated effectively, can lead to depression, anxiety and high blood pressure for the pregnant individual.

Editor’s note: SciCheck’s articles correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

With a growing number of Tylenol lawsuits being pursued by families that allege inadequate pregnancy warnings were provided about the risk autism and attention deficit hyperactivity disorder (ADHD), the U.S. government indicates that the FDA will submit it’s views on the labeling for over-the-counter acetaminophen products by September 15.

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the widespread belief that it was safe for unborn children. However, lawsuits now allege that the drug makers have failed to disclose information about the growing evidence that in utero exposure to acetaminophen may cause autism or ADHD.

Earlier this year, plaintiffs in the litigation submitted a template of proposed acetaminophen pregnancy warnings that could have been provided for consumers, recommending pregnant women the use of the lowest effective dose for the shortest possible time.

Although plaintiffs’ lawyers maintain that it is not necessary for families to provide any specific alternate language as a required element of their claims, the government’s input may play a crucial role in nearly 200 lawsuits being pursued against Johnson & Johnson, as well as major retailers who sold generic versions of the pain medication, including Walmart, CVS, Walgreens, Costco and others.

Each of the complaints raise similar allegations, indicating that information has been available to the manufacturers for decades about the link between autism and Tylenol, as well as ADHD, and other developmental problems. However, rather than warning about the acetaminophen risks, the drug has been actively promoted as safe for use by pregnant women.

FDA to Weigh in on Tylenol Lawsuit Label Warning Dispute
In April 2023, Judge Cote invited the U.S. Food and Drug Administration (FDA) to weigh in on the proposed warnings and provide the views of the U.S. government, including whether regulators think the plaintiffs’ proposed language should be added to acetaminophen labels and whether the current science warrants such warnings or advice for pregnant women regarding the risk of autism or ADHD. The Court asked for the FDA to submit comments by July 28, 2023, or as soon thereafter as possible.

This week, the U.S. Attorney for the Southern District of New York, Damian Williams, sent a response letter (PDF) on behalf of the FDA, indicating the agency needs more time to put together its response.

“The United States appreciates the Court’s consideration and had hoped to submit a response by July 28, but respectfully requests an enlargement of this date until September 15, 2023,” according to the letter. “The United States requires additional time to complete internal deliberations on this matter, especially given the schedules and availability of a number of key agency personnel whose input is needed.

In an order (PDF) issued on the same day, Judge Cote agreed to extend the deadline for any FDA opinion the Tylenol pregnancy warnings until September 15.

August 2023 Tylenol Autism and ADHD Lawsuit Update
While litigation continues to grow, Judge Cote has indicated the MDL will prioritize the early pretrial proceedings on discovery that focuses on the strength of the evidence that Tylenol causes autism and ADHD, and has appointed a special master to oversee discovery issues that arise.

A series of hearings are expected later this year, known as Dauberthearings, where the Court will evaluate the strength and reliability of proposed expect testimony submitted by each side.

Unless the drug makers are able to entirely dismiss the lawsuits at this stage, it is expected that Judge Cote will then establish a “bellwether” process, where a small group of representative cases will be selected for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Kenvue Inc (KVUE.N) cannot immediately appeal a federal judge's order allowing lawsuits claiming that its popular over-the-counter painkiller Tylenol can cause autism in children of mothers who take it during pregnancy, the judge has ruled.

U.S. District Judge Denise Cote in Manhattan on Thursday ruled that Kenvue, formerly Johnson & Johnson's (JNJ.N) consumer health unit, had not shown any basis for allowing the unusual step of an appeal to the 2nd U.S. Circuit Court of Appeals before final judgment in the case.

Nothing is more important to us than the health and safety of the people who use our products," a company spokesperson said in a statement. "The totality of scientific evidence shows there is no causal link between acetaminophen use during pregnancy and fetal developmental issues."

J&J still owns a majority of Kenvue, but is in the process of spinning it off.

A federal judicial panel last October consolidated dozens of lawsuits alleging that acetaminophen, the active ingredient in Tylenol and generic versions of the drug, can cause autism spectrum disorder and attention deficit hyperactivity disorder. As of July 17, 188 cases were pending.

In addition to Kenvue, lawsuits named retailers and pharmacies that sell Tylenol, including CVS Health, Rite Aid Corp, Safeway Inc, Target Corp and Walgreens Boots Alliance. They alleged the defendants failed to warn consumers about the risks.

The lawsuits cited recent studies that have found a higher risk of autism and ADHD in children exposed to acetaminophen in the womb.

In April, Cote denied Kenvue's motion to dismiss one of the lawsuits on the grounds that the U.S. Food and Drug Administration's approval of Tylenol's label preempted any state law claims. Had she ruled in the company's favor, it would have ended the entire litigation.

Later, she denied another motion to dismiss on the grounds that the claims lacked scientific support.

In denying Kenvue's motion for an immediate appeal, which the retailers supported, Cote said the company "has not pointed to any authority to suggest that there is any ground for a difference of opinion" on the preemption issue.

She said that the question of whether the plaintiffs had adequate scientific support could not be decided in a motion to dismiss, but would have to wait until a hearing on what expert testimony could be allowed in the litigation. Motions on which experts can be included are due next month.

It's more likely that Tylenol/paracetamol/acetaminophen reduces the risk of autism. Stress during pregnancy is a major risk factor for autism. Paracetamol could help reduce stress, thereby reducing the risk of autism.

Warning! Whoever reads the above paragraph, please don't misinterpret it as a recommendation to take paracetamol during pregnancy. Taking paracetamol during pregnancy is a bad idea and I certainly do NOT recommend it.

Tylenol should have been pulled from sale decades ago due to being incredibly dangerous and remarkably ineffective as a pain reliever.

Unlike most medications even slight overdoses on multiple occasions can lead to liver failure. Most other medications won't do that without a larger overdose.

I personally won't touch the stuff due to a genetic liver disease, but other people probably shouldn't either

Among the many safety concerns about medication use during pregnancy, health experts have long disagreed about acetaminophen (aka Tylenol) as a fever and/or pain reducer. Several past studies have shown potential links between acetaminophen use and neurodevelopmental concerns, such as language delays, autism, and ADHD. But one new study is squashing those worries, with researchers finding no substantive evidence after analyzing decades worth of data.

The study, published in the journal JAMA on Tuesday, April 9, was led by scientists from the Karolinska Institute in Sweden and Drexel University. Researchers analyzed medical data from about 2.5 million children born in Sweden between 1995 and 2019—from the prenatal period and beyond—finding no concrete link between acetaminophen use during pregnancy and developmental concerns.

Though the statistical model did find a “marginally increased risk” of autism, ADHD, and other intellectual disabilities, researchers also conducted a sibling analysis, looking at data from pairs of full biological siblings (i.e., those with the same parents) and found no real risk. The researchers note that sibling analyses are important because siblings share both genetic and environmental factors, which can help eliminate variables that might skew data in a clinical trial.

The study’s extensive time frame, large number of participants, and sibling analyses all help strengthen the results, refuting recent studies linking acetaminophen use during pregnancy to an increased risk of ADHD, childhood behavioral problems, language delays, and autism spectrum disorder. The findings also corroborate the stances shared by the US Food and Drug Administration and the European Medicines Agency, both of which call the OTC med low-risk for pregnant people.

acetaminophen synergistically boosts the effect of narcotics which it is often paired with in combo medications such as vicoden/lorcet.

that was very clever thinking on the part of those old chemists.

Not all of the effects, just the pain killing effects.

Acetaminophen blocks pain signals, morphine and other opioids alter how we perceive them. When acetaminophen is blocking some of them, the opioid has weaker signals to act on, the end result is a more effective painkiller than either on it's own.