Hundreds of “Tylenol lawsuits” already have been filed against retailers and manufacturers alleging they sold products containing acetaminophen to pregnant women, knowing the medications could harm the developing fetus.
Attorney W. Mark Lanier described the lawsuits — which allege acetaminophen use during pregnancy can cause children to be born with autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) — as “some of the most important health litigation pending in the United States right now.”
Lanier, founder and CEO of the Houston-based Lanier Law Firm involved in several high-profile product litigation lawsuits, told The Defender:
“Autism and mental health development or mental development issues touch a huge number of Americans. We believe the science indicates that taking Tylenol can cause many of these problems, period. We think the science backs this up, we think the biology backs it up, and we are eager to prove that in a court.
“The goal here is not to take Tylenol off the market. The goal here is to put a warning on it so that doctors and expectant mothers are able to make an intelligent decision of what risks they will expose their child to during pregnancy.”
In January 2015, the U.S. Food and Drug Administration (FDA) issued an acetaminophen pregnancy warning, stating expectant mothers should be cautious when using such products. The FDA, however, claimed there is “not enough research” to confirm safety risks for unborn children from acetaminophen exposure.
However, numerous peer-reviewed scientific studies appear to show such a link:
Data from the ongoing Boston Birth Cohort Study, sponsored by the Johns Hopkins Bloomberg School of Public Health, has indicated that “exposure to acetaminophen in the womb may increase a child’s risk for attention-deficit/hyperactivity disorder and autism spectrum disorder.”
A July 2022 study of acetaminophen published in Minerva Pediatrics “offers 17 lines of evidence that the commonly used remedy for pain and fever may be contributing to the autism epidemic,” as previously reported by The Defender. Dr. William Parker, the lead researcher on the study, told The Defender at the time that “acetaminophen would never be approved for pediatric use by today’s regulatory standards.”
A February 2022 study published in the European Journal of Pediatrics found that acetaminophen use in infants and children has never been shown to be safe for their neurodevelopment.
In September 2021, a consensus of 91 scientists, clinicians, and public health professionals published in Nature Reviews Endocrinology journal called for the FDA’s 2015 recommendations to be updated. The consensus stated that “increasing experimental and epidemiological research suggests that prenatal exposure to [acetaminophen] might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive, and urogenital disorders.” This study also found that acetaminophen was, in fact, never assessed for impact on neurodevelopment.
A June 2021 study published in the European Journal of Epidemiology found that children exposed to Tylenol and acetaminophen during pregnancy were significantly more likely to develop ASD and ADHD symptoms.
A September 2020 study published in JAMA Pediatrics suggested that the use of Tylenol and acetaminophen during pregnancy may impair the brain of a developing fetus. This could result in ADHD symptoms and other neurological disorders.
A January 2020 study published in European Psychiatry found that girls whose mothers took acetaminophen during pregnancy were six times more likely to suffer from delayed language development and used fewer words than normal by the age of 30 months.
An October 2019 Johns Hopkins study funded by the National Institutes of Health (NIH) found that exposure to acetaminophen during pregnancy may increase a child’s risk of developing autism and ADHD, as the children that had the highest acetaminophen metabolite levels in their blood showed the highest risk of developmental disorders. This study was published in JAMA Psychiatry.
A November 2017 study published in Pediatrics, based on data from the Norwegian Mother and Child Cohort Study, found that there is a possible association between short-term acetaminophen use during pregnancy and the risk of giving birth to a child who will later develop ADHD.
An October 2017 NIH study linked acetaminophen use by pregnant women to “lower performance intelligence quotient (IQ) … autism spectrum disorder, neurodevelopmental problems (gross motor development, communication), attention-deficit/hyperactivity disorder, poorer attention and executive function, and behavioral problems in childhood.”
A 2017 study published in the Journal of International Medical Research by renowned autism researchers from Duke, Harvard, and the University of Colorado found that “the long-term effects of acetaminophen exposure on neural development have never been evaluated in humans.” The study’s authors stated that even at very low doses, acetaminophen “triggers immune system activation and oxidative stress responses” — both potential warning signs of autism.
An October 2016 study published in JAMA Pediatrics suggested that the side effects of acetaminophen, when used during pregnancy, may increase the risk of children being born with behavioral problems such as hyperactivity and emotional difficulties.
A June 2016 study published in the International Journal of Epidemiology found that acetaminophen use during pregnancy was linked to a higher risk of autism among males and an increased prevalence of ADHD cases among both boys and girls.
An October 2013 study in the International Journal of Epidemiology found that children whose mothers took acetaminophen products during pregnancy for more than 28 days exhibited poorer than normal gross motor development, communication, externalizing behavior, and internalizing behavior.
A May 2013 study funded by the NIH found a link between circumcision-related acetaminophen use and the increased prevalence of autism.
The authors of a new review of the drug acetaminophen (paracetamol), sold under the brand names Tylenol and Panadol, are sounding the alarm about the use of the drug in infants and children, citing the drug’s association with autism spectrum disorder (ASD).
“Our study shows that acetaminophen would never be approved for pediatric use by today’s regulatory standards,” Dr. William Parker, of WPLab, Inc., who led the research team that conducted the review on acetaminophen and autism, told The Defender.
The review, published in the July issue of Minerva Pediatrics, offers 17 lines of evidence that the commonly used remedy for pain and fever may be contributing to the autism epidemic.
The authors said their findings could have huge implications for preventing ASD, as acetaminophen is used so much in young children — in some populations, up to 90% of children receive acetaminophen in their early years.
The rate of ASD has skyrocketed in the last 40 years, and now affects 1 in 40 U.S. children. Acetaminophen became the drug of choice to treat fevers and pain in children in the early 1980s, after aspirin was associated with Reye’s syndrome. However, the use of acetaminophen in infants and children was never shown to be safe for neurodevelopment.
“The belief that acetaminophen is safe for children is an assumption based on the fact many studies show it does not cause liver damage in children when used at an appropriate dose,” said Parker.
Parker and his colleagues previously conducted a systematic review, published in February in the European Journal of Pediatrics, which showed the studies claiming acetaminophen is safe for children did not examine the effect of the drug on neurodevelopment — even though the brain is one of the primary target organs for the drug’s therapeutic effect.
The key to understanding the role of acetaminophen in ASD is that acetaminophen alone does not trigger ASD — the negative impact happens in the presence of oxidative stress, according to Parker and his colleagues.
Oxidative stress is an imbalance of free radicals and antioxidants in the body that can lead to cell and tissue damage.
The body’s cells produce free radicals during metabolism, the chemical reactions that produce energy in our cells. These free radicals cause damage to cells and contribute to chronic illnesses and the aging process.
Unlike many drugs, some of the acetaminophen an individual takes is converted by the body into a highly toxic metabolite, N-acetyl-p-benzoquinone imine(NAPQI).
Usually, NAPQI is rapidly neutralized (rendered harmless) by glutathione, and because most healthy children have lots of glutathione, they aren’t harmed by NAPQI.
However, under conditions of oxidative stress, glutathione is depleted so the body can’t adequately remove the NAPQI. Left unremoved, the NAPQI reacts with a wide range of proteins, causing permanent damage to the proteins and associated cells.
Many babies and children are exposed to excessive oxidative stress through a variety of environmental and genetic factors including infection, treatment with antibiotics, vaccination, psychological stress, jaundice, heavy metals, problems with vitamin B metabolism, EMF exposure, exposure to cigarette smoke or air pollution and exposure to organophosphates.
Sources
https://childrenshealthdefense.org/defender/tylenol-babies-children-vaccination-autism/
https://childrenshealthdefense.org/defender/tylenol-lawsuits-acetaminophen-pregnancy-autism-adhd/
https://childrenshealthdefense.org/defender/tylenol-lawsuits-acetaminophen-pregnancy-autism-adhd/
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