What Is Tylenol?
Tylenol (acetaminophen) is one of the most common medications taken during pregnancy and one of the most common over-the-counter medications in the U.S. About two-thirds of all pregnant women in the U.S. may have taken Tylenol during their pregnancy. In some cases, women take it multiple times or for extended periods of time.
How Does Tylenol Work?
Acetaminophen, the active ingredient in Tylenol, works to block pain by preventing the creation and action of inflammatory chemicals called prostaglandins. Reducing these chemicals helps to reduce pain and reduce fever caused by inflammatory processes during illnesses such as infections.
Who Makes Tylenol?
Tylenol is manufactured by Johnson & Johnson, the largest consumer health and drug products manufacturer in the world. It was introduced as an elixir for children in 1955 by McNeil Laboratories which was acquired by Johnson & Johnson just 4 years later. By 1961, after adult regular-strength Tylenol tablets were released, it had become the best-selling pain reliever on the market.
Currently, brand-name Tylenol garners about $1 billion in annual sales for Johnson & Johnson.
What Are the Side Effects of Tylenol?
Like all medications, Tylenol may cause side effects. Most of these are mild to moderate and will go away with time.
Common side effects of Tylenol include:
- Loss of appetite
Other side effects may indicate more serious concerns including liver damage. More severe side effects include:
- Loss of appetite
- Dark urine
- Clay-colored stools
Liver damage may occur when too much Tylenol is taken or the medication is taken over too long of a period of time.
Is Tylenol Considered Safe During Pregnancy?
Though doctors warn that no medication can be considered completely “safe”, Tylenol is listed as Pregnancy Category B indicating that either:
- Animal studies do not show fetal risk but there are no studies in humans
- Animal studies show fetal risk but human studies do not show risk
Tylenol has generally been considered “safe” and thought to be much safer than other pain relievers and fever reducers including ibuprofen and aspirin which have been linked to birth defects of the heart and blood vessels.
Though newly published research has revealed possible links to autism, ADHD, and other birth defects, prompting experts to recommend warning labels for Tylenol, it is still listed as Category B in Pregnancy.
Has Tylenol Been Linked to Birth Defects?
Tylenol has generally been considered safe during pregnancy and is used by more than half of pregnant women. Recent evidence suggests that the medication may not be “risk-free” and that use during pregnancy may be associated with developmental birth defects including:
- Undescended testicles
- Abnormal urethral opening
- Reproductive disorders
- Autism Spectrum Disorder
- Other developmental disorders such as ADHD
How Has Tylenol Use During Pregnancy Been Linked to Autism?
Recent studies show that prenatal exposure to Tylenol (acetaminophen) has been linked to an increased risk of a child developing autism spectrum disorder (ASD) or autism.
A September 2021 issue of the medical journal Nature Reviews Endocrinology included a consensus statement from 91 researchers and medical experts who warn against Tylenol or acetaminophen use during pregnancy due to increased risk of autism and other neurological disorders. The longer or more often Tylenol was used, the higher the chance of autism.
What Studies Link Tylenol Use to Autism Spectrum Disorder?
One study, published in the European Journal of Epidemiology was performed at the University of Barcelona and looked at medical records of over 73,000 mother-child pairs. Separately, a consensus statement regarding paracetamol or acetaminophen, from 91 medical experts was published in the medical journal, Nature Reviews Endocrinology in September 2021. The experts had examined 29 observational and retrospective studies which examined records of over 220,000 mother-child pairs.
The researchers concluded that a link between substantial prenatal Tylenol use and an increased risk of the development of autism in children. Women who used Tylenol regularly or for extended times during pregnancy may have up to 20% increased risk of autism in those children.
The consensus experts determined that more Tylenol use was generally linked to greater autism risk. In addition, other examinations have linked Tylenol use to other neurodevelopmental disorders such as a 21% increased risk of attention deficit hyperactivity disorder (ADHD)
What Is Autism Spectrum Disorder?
Autism or autism spectrum disorder (ASD) is one of the fastest-growing developmental disorders affecting children. Estimates show that in 2018, 1 in 44 children were diagnosed with ASD. This is twice as many as were estimated to have ASD in 2008, just 10 years earlier.
Children diagnosed with autism spectrum disorder “ASD” or children on the “spectrum”, may have a range of disability from mild to severe.
Symptoms or characteristics of ASD include:
- Social difficulties
- Communication deficits
- Repetitive behaviors
- Limited interests or activities
- Functional impairment in school, work, or other areas
ASD symptoms are usually recognized before age two and are not generally considered controllable with diet or medications.
Are There Any Tylenol Autism Lawsuits?
Johnson & Johnson has faced multiple lawsuits filed by people and loved ones of those who have been harmed by Tylenol use due to liver injury. Claimants and settlements of liver injury lawsuits include people who experienced liver failure or were forced to undergo transplant surgery, people who died, and the parents of multiple children and infants who died due to Tylenol injury.
Johnson & Johnson may also be facing numerous lawsuits over claims of autism spectrum disorder (ASD) associated with Tylenol use during pregnancy. Parents or caregivers whose children were diagnosed with autism or autism spectrum disorder (ASD) after the mother took Tylenol during pregnancy may be eligible for compensation.
How Do I Find a Tylenol Attorney?
If you or someone you love have experienced liver damage or other severe side effects related to Tylenol, you should seek legal advice. Seeger Weiss, LLP, has an experienced team of attorneys who will offer you a free consultation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.