Since its introduction nearly sixty 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 widely popular among adults and children alike, and is commonly used to treat pain, fever, and cold, cough, flu and allergy symptoms. Regardless of the popularity of the over-the-counter pain reliever 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. If you have taken Tylenol as a pain reliever or fever reducer and have since experienced liver damage side effects, contact a Tylenol attorney today for legal help.
As consumers become aware of the potential for Tylenol to cause severe liver damage in users, 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:
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 contained in hundreds of other medications that are available over the counter or in prescription-strength, 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 without having to worry about a risk of dangerous side effects. However, the truth is that recent reports have tied acetaminophen (Tylenol) to a potential increased risk of serious liver injuries, including liver damage and liver failure.
Many consumers may be unaware that 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 cause damage to the liver. In most cases, this by-product is converted into a harmless substance by a certain antioxidant in the body, but 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 a coma.
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.
According to the FDA, acetaminophen (Tylenol) is the leading cause of acute liver failure in the United States, and the pain reliever is responsible for more than 100,000 calls to poison centers, approximately 60,000 emergency room visits, and hundreds of deaths each year in the United States. The following are some recent legal actions taken against the makers of Tylenol, McNeil Laboratories and Johnson & Johnson.
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 22, 2013 – Plaintiffs involved in the Tylenol litigation request that 28 Tylenol liver failure lawsuits be centralized for pretrial proceedings as part of a multidistrict litigation (MDL) in Pennsylvania.
June 20, 2013 – Tylenol lawsuits filed over liver injury from the pain reliever are centralized in a federal MDL.
May 23, 2014 – A product liability lawsuit is filed against Johnson & Johnson on behalf of a women who used Alka-Seltzer Plus Cough & Cold formula with acetaminophen, and suffered a life-threatening skin reaction called Stevens-Johnson syndrome (SJS).
January 30, 2015 – The first in a group of early trials involving alleged injuries from Tylenol is scheduled for June 2015.
Based on ongoing reports of severe liver injury from Tylenol, the FDA eventually added a “black box” warning to the drug label, which is the strongest warning the agency can use for pharmaceutical drugs. According to the FDA, acetaminophen overdoses were most common in patients who: took more than 4,000 mg of Tylenol in a 24-hour period; took more than one type of medicine containing acetaminophen; or consumed alcohol while taking acetaminophen. Other important FDA warnings regarding the alleged risk of Tylenol side effects include the following:
January 13, 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 1, 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 3, 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 15, 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 1, 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 4, 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 7, 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.
Millions of American adults and children use Tylenol every week for common ailments like head and body aches, colds and fevers, under the impression that the over-the-counter medication is safe enough for regular use. However, research has found that taking the daily recommended dose of Tylenol for just two weeks can cause mild to moderate liver injury in some people. The following are some of the most important studies linking Tylenol use to a possible increased risk of liver damage, liver failure and other injuries:
July 5, 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.
2011 – 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 25, 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 17, 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 15, 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 26, 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 24, 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 28, 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.
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 link studies have drawn between Tylenol use and an increased risk of liver damage and liver failure requiring a transplant. According allegations raised in the Tylenol litigation, plaintiffs who have suffered liver injury side effects potentially caused by the pain reliever accuse McNeil Laboratories and Johnson & Johnson of the following:
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, even in recommended doses. If you or a loved one has suffered an alleged Tylenol side effect like acetaminophen overdose or liver failure, 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 collect by filing a Tylenol lawsuit against Johnson & Johnson and McNeil Laboratories. By hiring a Tylenol lawyer to represent your case, you can protect your legal rights and collect the compensation you deserve.