What is Tylenol?
Tylenol (acetaminophen) is a pain-relieving, fever-reducing medicine that has been sold in the United States since the 1950s. It is manufactured by McNeil-PPC, a part of Johnson & Johnson. Every year, over 28 billion doses of acetaminophen are purchased. It is also an ingredient in Vicodin, which has been the most-prescribed drug since 1997. Unlike other painkillers, Tylenol is not addictive and does not normally cause stomach irritation or ulcers (unlike NSAID painkillers like aspirin and ibuprofen).
What is the problem?
For more than 30 years, Tylenol-induced liver failures have become increasingly common. The first cases were identified in the 1970s. Over then next few decades, Tylenol was advertised with slogans like “The pain-reliever hospitals use most,” and “The one more pediatricians give their own children.” At the same time, the U.S. Food and Drug Administration (FDA) approved hundreds of over-the-counter medicines containing acetaminophen.
Not surprisingly, by the 1990s, liver failure from Tylenol was a major public health problem. Between 1998 and 2003, the percentage of liver failures attributed to acetaminophen grew from 28% to 51%, making it the leading cause of liver failure in the United States.
Tylenol Lawsuit Prompts FDA Warnings on Alcohol
The first major FDA warning for Tylenol came in 1998, when recommended against drinking 3 or more alcoholic beverages when using acetaminophen. The action was prompted by a lawsuit filed by Antonio Benedi, a former aide to President George H.W. Bush, who fell into a coma and needed a liver transplant after taking Tylenol with wine at dinner. He was awarded $8.8 million for his injuries.
FDA Warning for Tylenol Liver Injury
In January 2011, the FDA published a Safety Communication to warn about the risk of liver damage from Tylenol and sharply restrict doses. Prescription painkillers are limited to 325-mg of acetaminophen per pill. They also required a Boxed Warning about “severe liver injury.”
Statistics on Tylenol Liver Damage
- Tylenol is the #1 cause of liver failure in the United States
- 100,000+ calls to Poison Control Centers
- 78,000 emergency room visits
- 33,000 hospitalizations
- 1,600 liver failures
- 458 deaths
- 48% of overdoses were accidental, 44% suicides, the rest unknown
- 1,500 deaths from accidental overdoses from 2003-2013
Why Do Tylenol Overdoses Occur?
- General lack of awareness about the liver risks of Tylenol. The perception of Tylenol as “safe” is probably due to decades of marketing Tylenol as superior to other painkillers, combined with the easy availability of high-dose Tylenol (e.g, bottles containing 500 pills) over-the-counter.
- There is a small margin of safety between a normal dose and an overdose. Even slightly exceeding the maximum recommended amount of Tylenol can cause liver damage. To address this risk, drug-makers lowered the maximum dose from 4,000-mg/day to 3,000-mg/day in 2011.
- The toxicity level differs for everyone. Daily-doses as low as 2,500-mg have been linked to rare cases of liver damage. Genetic factors, pre-existing liver problems, poor nutrition, low body weight, and drinking alcohol increase the risk of liver toxicity from normal doses of Tylenol.
- It is easy to accidentally take more than one medicine containing Tylenol. Most people know that Tylenol contains acetaminophen, but did you know that over 600 other medicines also contain acetaminophen? These medicines include prescription painkillers (Vicodin, Percocet, etc.) and over-the-counter drugs for cough, cold, fever, flu, allergies, insomnia, headache, menstrual symptoms, and more.
- Symptoms of a Tylenol overdose can be easily mistaken for the flu. Nausea, vomiting, abdominal discomfort, and jaundice are common symptoms of a Tylenol overdose. However, they may not appear for several days after an overdose, even when serious liver damage is occurring.
Symptoms of Liver Damage
- Abdominal pain and swelling (upper-right side)
- Nausea, vomiting
- Loss of appetite
- Jaundice (yellowing of skin, eyes)
- Fatigue, sleepiness
- Diarrhea or indigestion
- Dark-colored urine
- Clay-colored stools
- Confusion or disorientation
What About Small Tylenol Overdoses?
In 2009, a study published in the British Journal of Clinical Pharmacology estimated that 25% of acetaminophen-induced liver injuries were “staggered overdoses” — small, repeated liver injuries from lower doses of acetaminophen, usually in the self-treatment of chronic pain. Unfortunately, nearly 40% of staggered overdose patients died, compared to 28% of singe-time overdose patients.
How Does Tylenol Damage the Liver?
When you take a dose of Tylenol, it is absorbed through the gastrointestinal system and released into the bloodstream. The blood is filtered by the liver, which metabolizes Tylenol into substances that can be excreted. About 90% is excreted in urine and bile. About 5-10% is metabolized into a highly-toxic byproduct called NAPQI (N-acetyl-p-benzoquinone imine).
Normally, the liver immediately detoxifies NAPQI by combining it with another substance in the liver called glutathione. When an overdose of Tylenol is ingested, the normal glutathione reserves are depleted and large amounts of NAPQI are produced. NAPQI is very reactive and will bind to proteins and nucleic acids, resulting in hepatocellular death and necrosis of liver tissue.
Treatment for Tylenol Liver Damage
Immediately after a Tylenol overdose, doctors may use a gastric lavage (stomach pump) and activated charcoal to eliminate medication that has not already been absorbed into the body. N-Acetyl-cysteine (NAC) has been used as an “antidote” in the treatment of Tylenol overdoses since the 1980s. NAC binds to NAPQI, the toxic byproduct of Tylenol, and helps the body excrete it in bile.
Healthcare professionals use the Rumack-Matthew nomogram to determine how much NAC to administer. If the patient’s values are above the threshold for hepatotoxicity, the patient is normally given NAC. If the antidote is given within 16 hours of an overdose, it can often prevent liver failure. NAC can also improve survival if given within 48 hours of an overdose.
If the patient develops acute liver failure, he or she will need a liver transplant to survive. Because healthy livers are in high demand, there is a long waiting list. Unfortunately, about one-fifth of people who need a new liver do not survive long enough to receive a transplant.
Tylenol Lawsuits Centralized in Federal Court
Instead of a Tylenol class action, lawsuits have been centralized in a federal Multi-District Litigation (MDL). Plaintiffs allege that over-the-counter Tylenol can cause liver damage, including liver failure, even when taken as directed. Since the Tylenol MDL was established in April 2013, more than 85 Tylenol lawsuits have been filed.
The litigation is expected to grow much larger in the coming years as more people come forward to seek justice for their injuries from Johnson & Johnson, McNeil-PPC, Inc., and other defendants. The cases are pending in the U.S. District Court for the Eastern District of Pennsylvania, overseen by Judge Lawrence F. Stengel:
- MDL No. 2436, In re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation
Tylenol Side Effects
- Liver damage
- Jaundice (yellowing of skin, eyes)
- Elevated liver enzymes in blood tests
- Liver failure
- Hepatic encephalopathy (brain damage)
- Allergic reactions
- Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis