Tylenol-brand medications  are popular over-the-counter (OTC) drugs  marketed by Johnson & Johnson’s McNeil Consumer Healthcare division. Tylenol, Extra-Strength Tylenol and other medications included in this product line contain acetaminophen, a painkiller that can cause severe liver injuries, including liver failure, if taken in inappropriate doses.

Tylenol Brand Medications

The first Tylenol product was introduced in 1955 as Tylenol Elixer for Children. Since then, medications bearing the name Tylenol have become ubiquitous in U.S. homes, with Americans purchasing 28 billion doses in 2005 alone. Some of the OTC drugs that are currently sold under the Tylenol-brand name include:

  • Tylenol Regular Strength
  • Tylenol Extra Strength
  • Tylenol Arthritis Pain
  • Tylenol Extended Relief
  • Tylenol Cold & Flu
  • Tylenol Cold Max
  • Tylenol Cold & Head
  • Tylenol Sinus & Headache
  • Tylenol Sinus Severe
  • Tylenol PM
  • Infants Tylenol
  • Children’s Tylenol

Concerns Surrounding Acetaminophen

According to data from the U.S. Food & Drug Administration (FDA), acetaminophen, the active ingredient in Tylenol products, was the leading cause of acute liver failure in the U.S. between 1998 and 2003. From 1990 to 1998, the ingredient was cited as the cause of 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths annually.

Symptoms of a severe acetaminophen overdose include:

  • Loss of appetite
  • Nausea, and vomiting,
  • Abdominal pain
  • Convulsions
  • Diarrhea
  • Irritability
  • Jaundice
  • Coma

McNeil Announces New Liver Warnings for OTC Tylenol Products

In August 2013, McNeil Consumer Healthcare announced that it would add  more prominent liver damage warnings to the labels of Tylenol products. The new red-lettered warning labels first began appearing on bottles of Extra Strength Tylenol that October. Read More

Consumer Reports Investigation Highlights Acetaminophen Dangers

In November 2014, a Consumer Reports investigation highlighted the dangers associated with acetaminophen. Among other things, the investigation found that acetaminophen overuse sends more than 80,000 people to the emergency room every year. The article also detailed research that suggests exceeding just 4,000 milligrams of acetaminophen for only a few days can result in serious liver damage and other complications. However, Consumer Reports noted that daily limits recommended for many OTC acetaminophen products come very close to this threshold. Read More

FDA Actions to Mitigate Acetaminophen Liver Risks

In recent years, the FDA has taken a number of actions to mitigate the risk of acetaminophen-related liver injury:

  • January 2014: The FDA finalized new guidance for the use of acetaminophen in prescription medications. However, these new guidelines do not apply to over-the-counter medications like Tylenol. Read More
  • Man 2014: An FDA alert notes that cases of serious liver damage have occurred among consumers who used an OTC acetaminophen medication concurrent with a prescription drug that also contained the ingredient. According to the agency, this scenario has been responsible for a significant proportion of acetaminophen-related liver failure cases in the U.S., some of which have resulted in liver transplantation and death. Read More
  • October 2014: The FDA issues draft guidance for over-the-counter liquid pediatric medications that contain acetaminophen in order to reduce the risk of serious liver injury and death. The guidance includes voluntary labeling and formulation recommendations meant to “avoid confusion and the potential for dosing errors” Read More

Tylenol Liver Damage Lawsuits

In April 2013, all federally-filed Tylenol liver damage claims were centralized in the U.S. District Court, Eastern District of Pennsylvania, for the purpose of coordinated pretrial proceedings. All of the claims pending in the proceeding accuse Johnson & Johnson and McNeil of failing to provide consumers with adequate warnings regarding the association between Tylenol and liver injury. As of March 2016, more than 200 Tylenol lawsuits had been filed in the litigation. (In Re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation, MDL No. 2436)

  1. FDA (2009) “Acetaminophen Overdose and Liver Injury — Background and Options for Reducing Injury” http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
  2. Bloomberg News (2013) J&J Adds Warning to Tylenol Caps on Acetaminophen Risk http://www.bloomberg.com/news/articles/2013-08-29/j-j-adds-warning-to-tylenol-caps-on-acetaminophen-risk
  3. Consumer Reports (via 5 ABC News) (2014) “Warning about Acetaminophen: Consumer Reports investigates” http://www.newsnet5.com/money/consumer/consumer-specialist/warning-about-acetaminophen-consumer-reports-investigates
  4. LA Times (2014) “Acetaminophen in Rx drugs: For liver’s sake, lower the dose, says FDA” http://www.latimes.com/science/sciencenow/la-sci-sn-extra-strength-acetaminophen-fda-20140428-story.html
  5. FDA (2014) “Sometimes Drugs and the Liver Don’t Mix” http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm398855.htm
  6. FDA (2014) “Guidance for Industry” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417568.pdf
Last Modified: April 13, 2016

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