Did You Suffer Side Effects of Tylenol?
People who take the popular over-the-counter pain reliever Tylenol may have an increased risk of suffering liver damage and liver failure possibly requiring a transplant. Some scientific research has also shown that children born to women who took Tylenol during pregnancy may be significantly more likely to develop autism or ADHD in childhood.
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Tylenol Lawsuits
People who take the popular over-the-counter pain reliever Tylenol may have an increased risk of suffering liver damage and liver failure possibly requiring a transplant. Some scientific research has also shown that children born to women who took Tylenol during pregnancy may be significantly more likely to develop autism or ADHD in childhood.
Since its introduction nearly 70 years ago, Tylenol has become one of the best-selling pain-relieving medications in all of North America. The brand name Tylenol (acetaminophen) is owned by McNeil Laboratories, which is a subsidiary of pharmaceutical giant Johnson & Johnson. Although McNeil originally marketed Tylenol Elixir to children, the medication quickly became popular among adults and children alike and is now commonly used to treat pain, fever, cold, cough, flu, and allergy symptoms. However, Tylenol has become the subject of significant scrutiny in recent years, due to concerns about potential overdose and liver failure side effects associated with the medication and its active ingredient, acetaminophen. And even more so because of the alleged potential for Tylenol use in pregnancy to increase the risk of autism and/or ADHD in exposed children. If you took Tylenol as a pain reliever or fever reducer and experienced one of these side effects, fill out the form or call our consumer advocates right away to discuss your options.
Tylenol Alternatives for Pain Relief
As consumers become aware of the potential for Tylenol to cause severe liver damage in users and to possibly increase the risk of autism and/or ADHD in children exposed in utero, more and more people are turning to alternative treatment methods to reduce fever, treat coughs and colds, and relieve minor head and back pain, rather than exposing themselves to alleged Tylenol side effects. Some common natural or holistic alternatives to Tylenol for pain relief include the following:
- Capsaicin – Derived from hot chili peppers, topical capsaicin may be a helpful method of relieving pain for some people. It works by depleting the compound that conveys the pain sensation from the peripheral to the central nervous system.
- Ginger – Ginger extract contains phytochemicals, which can stop inflammation and may therefore help relieve joint and muscle pain in some people.
- Turmeric – Turmeric is a spice that can be used to relieve heartburn, inflammation, and pain from arthritis.
- Acupuncture – Acupuncture is believed to decrease pain by promoting the release of chemicals called endorphins that block the sensation of pain.
- Massage and/or chiropractic treatment – Chiropractic treatment is the most common non-surgical method of relief for back pain and massage is becoming more and more popular among people suffering from chronic neck and back problems.
- Nutritional supplements – There is some evidence indicating that nutritional supplements like glucosamine, chondroitin, and fish oils may be beneficial for pain relief.
What is Tylenol?
Tylenol (acetaminophen) is one of the best-selling medications in the world, commonly used over the counter as a treatment for mild to moderate pain, fever, coughs, colds, and the flu. The active ingredient in Tylenol, acetaminophen, is also found in more than 600 other medications that are available over the counter or in prescription-strength formulations, including Benadryl, Excedrin, Dayquil, Theraflu, Robitussin, Percocet, and Vicodin. Tylenol was initially approved by the FDA in 1951, and because it has been on the market in the United States for more than six decades, most people assume that the pain reliever is safe to use and does not carry any risk of dangerous side effects. However, the truth is that recent reports have tied acetaminophen (Tylenol) to a potentially increased risk of serious side effects, including liver damage and liver failure, as well as an alleged risk of autism spectrum disorder (ASD) and/or attention-deficit/hyperactivity disorder (ADHD) in children when used during pregnancy.
Alleged Side Effects Leading to a Tylenol Injury Lawsuit
Many consumers are unaware that a Tylenol overdose possibly leading to liver failure can occur as a result of a one-time unintentional acetaminophen overdose, resulting in symptoms like nausea, vomiting, diarrhea, sweating, irritability, and appetite loss. In fact, experts have warned that even healthy people taking Tylenol as recommended may be at risk of suffering life-threatening Tylenol side effects like overdose and liver failure. Acetaminophen is metabolized in the liver, which results in a by-product that can damage the liver. In most cases, this by-product is converted into a harmless substance by a certain antioxidant in the body. However, taking large doses of Tylenol can cause this antioxidant to become overwhelmed, potentially resulting in irreversible damage to liver cells indicative of liver failure. Common symptoms of liver failure include jaundice, swollen abdomen, bleeding easily, and sometimes even coma.
Consumers may also be shocked to learn that, while Tylenol is widely regarded as a safe medication for use in pregnancy, more than two dozen studies published in recent years have established a possible connection between using acetaminophen (Tylenol) while pregnant and the development of autism and/or ADHD in children. A growing number of families nationwide are now pursuing legal claims against Johnson & Johnson and other acetaminophen manufacturers and retailers, alleging that their children’s diagnosis of autism or ADHD was caused by Tylenol or acetaminophen use and could have been avoided had consumers been properly warned about this potential side effect risk.
Link Between Tylenol and Liver Failure
According to reports, acetaminophen (Tylenol) causes three times as many instances of liver failure as all other drugs combined and accounts for 39% of all cases of liver failure in the United States. In a 2006 study published in the Journal of the American Medical Association, researchers warned that even healthy adults taking the maximum daily recommended dose of Tylenol for just two weeks had abnormal liver test results. Furthermore, the FDA’s Adverse Events Reporting System received 404 reports of acute liver failure in 2005, a significant increase from the 89 reports received in 1995, and the drug most commonly associated with these acute liver failure reports was acetaminophen (Tylenol). Information about Tylenol overdose and liver failure side effects finally led to the FDA recommending stronger warning and dose limits on drugs containing acetaminophen, including Tylenol, in 2009.
Link Between Tylenol and Autism, ADHD
For decades, pregnant women have been taking Tylenol to relieve pregnancy-related pain, mild fevers, and minor discomforts, including headaches and backaches. After all, Tylenol has long been regarded as safe for pregnant women and developing babies and it remains the most widely used medicine during pregnancy. As many as 65% of American women say they took Tylenol or another acetaminophen-containing medication while pregnant, many at their healthcare provider’s recommendation. Sadly, it appears that Tylenol may not be as safe as once believed, considering emerging research highlighting the possible fetal risks associated with maternal Tylenol use, including a potential increased risk of developing autism and/or ADHD in childhood.
Lawsuits Against Tylenol for Liver Injury, Liver Failure, and Autism/ADHD
2007 – A Philadelphia judge upholds a $5 million jury verdict brought against Johnson & Johnson in a case involving a one-year-old child who died from liver failure after taking Infants’ Tylenol.
2012 – McNeil and J&J face a lawsuit filed by a Florida woman who, after taking Tylenol as directed for a few days, was rushed to the hospital, where she was diagnosed with liver failure. She required an almost two-week stay at the hospital in order to recover from the acetaminophen overdose.
January 2013 – Plaintiffs involved in the Tylenol litigation request that 28 Tylenol injury lawsuits be centralized for pretrial proceedings as part of a multidistrict litigation (MDL) in Pennsylvania.
June 2013 – Tylenol lawsuits filed over liver injury from the pain reliever are centralized in a federal MDL.
May 2014 – A product liability lawsuit is filed against Johnson & Johnson on behalf of a woman who used Alka-Seltzer Plus Cough & Cold formula with acetaminophen and suffered a life-threatening skin reaction called Stevens-Johnson syndrome (SJS).
January 2015 – The first in a group of early trials involving alleged injuries from Tylenol is scheduled for June 2015.
June 2022 – A mother in Washington state files one of the first Tylenol lawsuits against Walmart on behalf of her minor daughters, both of whom she alleges suffered side effects of acetaminophen use during pregnancy. “Increasing experimental and epidemiological research shows that prenatal exposure to [acetaminophen] alters fetal development, which significantly increases the risks of neurodevelopmental disorders, including but not limited to, ASD and ADHD,” her lawsuit states. According to the claim, both of her daughters have developed ADHD and one was being tested for autism at the time the complaint was filed.
October 2022 – The Judicial Panel on Multidistrict Litigation (JPML) creates an acetaminophen ASD/ADHD multidistrict litigation (MDL) in the U.S. District Court for the Southern District of New York, stating that all Tylenol autism lawsuits filed in federal courts nationwide will be transferred there.
January 2023 – A Tylenol lawsuit filed against CVS Pharmacy, Walgreens, and Walmart alleges that the defendants were negligent in failing to warn the plaintiff or her healthcare providers about the potential link between acetaminophen use during pregnancy and autism.
January 2023 – The federal judge overseeing the Tylenol autism and ADHD litigation orders plaintiffs to submit an example of a warning that could have been added to the acetaminophen label informing users about the potential fetal risks of using Tylenol during pregnancy
February 2023 – In an attempt to avoid liability for Tylenol autism and ADHD claims, Johnson & Johnson files a motion to dismiss all federal Tylenol lawsuits. The healthcare giant claims in the motion that failure to warn claims are preempted by federal law.
April 2023 – The Tylenol MDL judge rejects Johnson & Johnson’s motion, finding that the manufacturer could have added warnings about the link between maternal Tylenol use and possible injury to the fetus without violating federal law.
May 2023 – Johnson & Johnson files a motion for certification of an interlocutory appeal, asking a higher court to review the matter.
June 2023 – To date, there are more than 130 acetaminophen ASD/ADHD lawsuits pending in the federal MDL in New York.
FDA and Tylenol Side Effects
January 2011 – The FDA confirms the link between Tylenol and severe liver injury and adds a “black box” warning, the strongest warning the agency can use for pharmaceutical drugs, to all prescription medications containing acetaminophen
January 2011 – A press release issued by the FDA requires manufacturers of prescription combination products containing acetaminophen to limit the amount of acetaminophen in their medications to no more than 325 mg per tablet or capsule. The agency also required manufacturers to update the warning labels on their medications to include the risk of severe liver injury from acetaminophen overdose.
August 2013 – The FDA issues a drug safety communication warning consumers and the medical community about the risk of rare but serious Stevens-Johnson syndrome skin reactions from normal doses of Tylenol.
September 2013 – A red cap and new warnings will be added to Tylenol (acetaminophen) products in an effort to reduce the risk of accidental overdoses, liver failure, and liver damage side effects.
January 2014 – The FDA warns against the use of prescription combination medications that contain more than 325 mg of acetaminophen per tablet, indicating that there is no available data to show that taking more than 325 mg of acetaminophen provides additional benefits that outweigh the added risk of liver damage.
May 2014 – According to a safety reminder issued by the FDA, doctors and pharmacists should no longer prescribe or dispense prescriptions for combination painkillers containing more than 325 mg of acetaminophen per tablet.
June 2014 – The FDA issues a warning notifying consumers that there is no reliable method of predicting who may be susceptible to liver damage side effects from Tylenol. According to reports, acetaminophen overdose is the most common cause of drug-related liver injury in the United States.
October 2014 – Federal regulators recommend clearer labels on over-the-counter liquid acetaminophen medications for kids, to reduce the rate of liver injury side effects from accidental overdoses.
January 2015 – In light of growing concerns about the safety of prescription and over-the-counter (OTC) pain medicines taken by pregnant women, the FDA warns that “the use of pain medicines during pregnancy should be carefully considered.” The agency also urges pregnant women to “always discuss all medicines with their health care professionals before using them.”
April 2023 – The federal judge presiding over the acetaminophen autism/ADHD MDL asks the FDA to review the proposed acetaminophen pregnancy warning presented by the plaintiffs and submit comments by July 2023.
Tylenol Side Effect Studies
July 2006 – A study published in the Journal of the American Medical Association examined 145 patients administered either a placebo or 4,000 mg of Tylenol (the maximum daily recommended dose), once per day for two weeks. According to their findings, study participants who were administered Tylenol had 33-44% higher levels of a liver enzyme called ALT, which is indicative of liver damage.
February 2012 – According to a study published in the British Journal of Clinical Pharmacology, 70% of the 663 people hospitalized for acute liver toxicity associated with acetaminophen between 1992 and 2008, took a single large dose, and 25% took staggered doses that resulted in an acetaminophen overdose. Two-thirds of the study participants received treatment without a liver transplant and survived, 25% died without receiving a transplant, and 15% received a liver transplant and died.
May 2012 – Researchers warn that roughly 2.5% of hospital patients are administered unsafe doses of Tylenol on at least one day during their hospital stay.
September 2012 – Research published in the American Journal of Epidemiology warns that women who take large amounts of Tylenol may face an increased risk of experiencing hearing loss.
July 2013 – A study published in Liver Transplantation has found that people who overdose on Tylenol (acetaminophen) and suffer acute liver failure have a poorer prognosis than people who develop non-drug-induced liver failure.
September 2013 – Researchers from ProPublica find that accidental overdoses from Tylenol result in approximately 150 deaths every year. According to the report, between 2001 and 2011, roughly 1,567 deaths were associated with accidental Tylenol overdoses.
February 2014 – A study published in JAMA Pediatrics indicates that women who use Tylenol (acetaminophen) during pregnancy may have a higher risk of giving birth to a baby with attention-deficit hyperactivity disorder (ADHD), or a brain and behavior disability called hyperkinetic disorder (HKD).
July 2014 – The medical journal The Lancet publishes a study indicating that Tylenol (acetaminophen) is no better than a placebo at treating lower back pain, suggesting that the risk of liver damage from Tylenol may outweigh the benefits of the pain reliever.
April 2018 – According to a meta-analysis of 132,738 mother-child pairs published in the American Journal of Epidemiology, “Acetaminophen use during pregnancy is associated with an increased risk for ADHD, ASD, and hyperactivity symptoms.”
October 2019 – The journal JAMA Psychiatry publishes a study in which researchers find a connection between cord plasma biomarkers of fetal exposure to acetaminophen and a “significantly increased risk of childhood attention-deficit/hyperactivity disorder and autism spectrum disorder.”
May 2021 – A meta-analysis of six European population-based cohorts finds that children born to women who took Tylenol while pregnant were 19% more likely to develop autism and 21% more likely to develop ADHD.
September 2021 – A Consensus Statement published in Nature Reviews Endocrinology calls for precautionary action in light of research suggesting that “prenatal exposure to APAP [acetaminophen] might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders.”
Why We Think Manufacturers Should Be Held Liable for Acetaminophen Side Effects
In addition to Tylenol, acetaminophen can be found in more than 600 prescription and over-the-counter medications, and the pain reliever has generated more than $1 billion a year for McNeil Laboratories and its parent company, Johnson & Johnson. This is in spite of the potential connection studies have drawn between: 1. Tylenol use and an increased risk of liver damage and liver failure requiring a transplant, and 2. the risk of autism spectrum disorder or attention-deficit/hyperactivity disorder from Tylenol use in pregnancy. According to allegations raised in the ongoing Tylenol litigation, plaintiffs who have suffered side effects potentially caused by acetaminophen accuse Johnson & Johnson and other manufacturers/retailers of the following:
- Manufacturing a defective medication and selling it to consumers
- Failing to provide adequate warnings about the alleged risk of liver failure and autism/ADHD from Tylenol use
- Allowing consumers to believe for years that Tylenol was safe for regular use, including during pregnancy
- Knowing about the potential for Tylenol to cause liver damage and autism/ADHD side effects, but withholding this crucial information from the public
July 2006 – A study published in the Journal of the American Medical Association examined 145 patients administered either a placebo or 4,000 mg of Tylenol (the maximum daily recommended dose), once per day for two weeks. According to their findings, study participants who were administered Tylenol had 33-44% higher levels of a liver enzyme called ALT, which is indicative of liver damage.
February 2012 – According to a study published in the British Journal of Clinical Pharmacology, 70% of the 663 people hospitalized for acute liver toxicity associated with acetaminophen between 1992 and 2008, took a single large dose, and 25% took staggered doses that resulted in an acetaminophen overdose. Two-thirds of the study participants received treatment without a liver transplant and survived, 25% died without receiving a transplant, and 15% received a liver transplant and died.
May 2012 – Researchers warn that roughly 2.5% of hospital patients are administered unsafe doses of Tylenol on at least one day during their hospital stay.
September 2012 – Research published in the American Journal of Epidemiology warns that women who take large amounts of Tylenol may face an increased risk of experiencing hearing loss.
July 2013 – A study published in Liver Transplantation has found that people who overdose on Tylenol (acetaminophen) and suffer acute liver failure have a poorer prognosis than people who develop non-drug-induced liver failure.
September 2013 – Researchers from ProPublica find that accidental overdoses from Tylenol result in approximately 150 deaths every year. According to the report, between 2001 and 2011, roughly 1,567 deaths were associated with accidental Tylenol overdoses.
February 2014 – A study published in JAMA Pediatrics indicates that women who use Tylenol (acetaminophen) during pregnancy may have a higher risk of giving birth to a baby with attention-deficit hyperactivity disorder (ADHD), or a brain and behavior disability called hyperkinetic disorder (HKD).
July 2014 – The medical journal The Lancet publishes a study indicating that Tylenol (acetaminophen) is no better than a placebo at treating lower back pain, suggesting that the risk of liver damage from Tylenol may outweigh the benefits of the pain reliever.
April 2018 – According to a meta-analysis of 132,738 mother-child pairs published in the American Journal of Epidemiology, “Acetaminophen use during pregnancy is associated with an increased risk for ADHD, ASD, and hyperactivity symptoms.”
October 2019 – The journal JAMA Psychiatry publishes a study in which researchers find a connection between cord plasma biomarkers of fetal exposure to acetaminophen and a “significantly increased risk of childhood attention-deficit/hyperactivity disorder and autism spectrum disorder.”
May 2021 – A meta-analysis of six European population-based cohorts finds that children born to women who took Tylenol while pregnant were 19% more likely to develop autism and 21% more likely to develop ADHD.
September 2021 – A Consensus Statement published in Nature Reviews Endocrinology calls for precautionary action in light of research suggesting that “prenatal exposure to APAP [acetaminophen] might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders.”
Non Tylenol Lawsuit Drug Topics
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What should you do? If you or your child has suffered liver damage, autism, ADHD, or another serious side effect, you should contact an attorney as soon as possible to discuss filing a Tylenol lawsuit.
Start Your Claim Now!
Drug companies like McNeil are responsible for the safety and effectiveness of their medications and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, many consumers remain unaware of the risk of liver failure side effects allegedly associated with the use of Tylenol or the risk of autism/ADHD in children exposed to acetaminophen (Tylenol) in pregnancy, even in recommended doses. If you or a loved one has suffered an alleged Tylenol side effect like acetaminophen overdose, liver failure, autism, or ADHD, contact a reputable Tylenol attorney today to discuss your options for legal recourse. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can pursue by filing a Tylenol lawsuit. By hiring a Tylenol lawyer to represent your case, you can protect your legal rights and pursue the compensation you deserve.
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