TYLENOL & Liver Failure

Popular Over-the-Counter Pain Reliever Tylenol Linked to Liver Failure

Tylenol has been the over-the-counter medication of choice for many to treat headaches, tooth aches, muscle pain, and flu symptoms like fever. Yet, despite its popularity among consumers, Tylenol has experienced a long and troubling history dotted with recalls and links to serious side effects.

In the past couple of years, recalls have been issued for Tylenol products over strange smells in the medication, faulty mechanisms in the packaging, or inappropriate dosage amounts. Studies have also shown a connection between the use of Tylenol and life-threatening liver failure.

The Facts: Tylenol (Acetaminophen)

• Tylenol (acetaminophen) is manufactured by Johnson and Johnson. It received FDA approval in 1951.
• Between 2009 and June 2012, there were more than a dozen Tylenol recalls, including children’s products. The products were recalled over strange odors, bacterial contamination, labeling problems, dosing problems, and problems with equipment used to manufacture the drugs.
• The FDA issued a “Black Box” warning – its highest possible warning – for some Tylenol prescription medications in June 2009 about the increased risk of liver damage.
• The FDA announced in January 2011 that it would ask all manufacturers of products containing acetaminophen to limit the dose to no more than 325 mg per capsule or tablet (to be effective in 2014). The FDA also issued a boxed warning for acetaminophen products about the risks of liver injury.
• In March 2011, the FDA and the Justice Department took control of three Johnson and Johnson Tylenol factories and began a criminal investigation of safety at the plants.

Tylenol Recalls

A number of recalls have been issued over the last several years for Tylenol products. These include:

• September 2009: Children and infant’s Tylenol; possible bacterial contamination
• November 2009: Tylenol Arthritis Pain Caplets; strange odor and taste
• December 2009: Tylenol Arthritis Pain Caplets (second wave)
• January 2010: various Tylenol and Motrin products; musty odor
• March 2010: Children’s Tylenol; labeling problem
• April 2010: Children and infant’s Tylenol products; quality control problems
• June 2010: Extra-strength Tylenol and Benadryl; musty odor
• July 2010: Children's Tylenol, Tylenol Extra Strength, Tylenol PM, Benadryl, Motrin; contamination
• October 2010: Tylenol 8-hour Caplets, 50-count bottles; musty odor
• November 2010: Tylenol Cold Multi-Symptom Liquid; labeling errors
• January 2011: Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol treatments for upper respiratory conditions; equipment cleaning problems
• March 2011: Tylenol 8-Hour Extended Release caplets; musty odor
• May 2011: Tylenol eight-hour extended-release caplets; musty or moldy odor
• June 2011: Tylenol Extra Strength Caplets; strange odor
• August 2011: Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps
• February 2012: Infants’ Tylenol; faulty dosing mechanism

Click here for a complete list of recalled products.

The FDA took over three Tylenol plants in March 2011 after a series of recalls prompted an investigation into the manufacturing process. In addition, the FDA charged two executives of subsidiary McNeil PPC for failing to comply with federally mandated manufacturing practices.

The FDA investigation found more than 20 violations of manufacturing protocols at the plants, including sanitation issues and safety practices.

Tylenol and Liver Failure

In addition to the safety issues posed by the recalled Tylenol products, there have been several studies indicating a link between the use of acetaminophen and liver failure.

In 2009, the FDA issued its strongest possible warning – a “Black Box” warning – for prescription medications that combine acetaminophen with another drug, such as Tylenol 3 with codeine, because of the increased risk of liver damage. It followed up with a request for a boxed warning on all products containing acetaminophen that highlighted the risk of liver injury.

A 2011 study in the British Journal of Clinical Pharmacology found that taking Tylenol or other products with acetaminophen repeatedly – known as “staggered overdose” – can result in liver failure.

A 2012 study in the Journal of General Internal Medicine found that almost 25 percent of U.S. adults don’t understand how much Tylenol is safe to take, leading to potential overdose. The study also found that nearly 50 percent of adults don’t realize how many over-the-counter medications contain acetaminophen, putting them at risk of overdose by taking too many of these drugs.

North Carolina Tylenol Lawyers

If you took one of the recalled Tylenol products, or you believe that taking Tylenol led to your liver failure or other serious health problems, you may be entitled to compensation for your injuries. Call the Law Offices of James Scott Farrin to find out if one of our North Carolina defective products lawyers may be able to help or if you have a potential Tylenol lawsuit.

Call 1-866-844-4262, fill out our contact form to the right or chat now with one of our representative for a free evaluation of your case. There is no obligation, and our representatives are available 24 hours a day, 7 days a week to help you. You can also use the live chat feature to talk with one of our representatives, or fill out the secure, confidential intake form on this page.

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