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Report: Tylenol Liver Damage Warnings Decades Late

A new report from a non-profit, independent journalism group claims that delayed warnings about the link between Tylenol and liver damage could have brought about thousands of injuries and hundreds of deaths.

The investigative report, published by ProPublica and This American Life, highlight the fact that the makers of Tylenol, Johnson & Johnson’s NcNeil Healthcare division, knowingly avoided enhancing warnings or taking other safety measures to help protect consumers from the risk of liver injury associated with acetaminophen, the main ingredient in Tylenol.

The report also claims that the FDA did not act quickly to reduce the risk of liver damage for Tylenol users.

Every year, roughly 150 people die of an acetaminophen overdose in the United States—roughly 1,567 acetaminophen deaths have been reported in this country between 2001 and 2010. The recent article also states that in both 2010 and 2011, Tylenol generated more than $1.5 billion in sales for Johnson & Johnson and that the company spends hundreds of millions of dollars on advertising campaigns highlighting the safety of Tylenol.

Acetaminophen, which is in Tylenol and countless other over-the-counter and prescription pain medications, is the leading cause of liver failure in the United States. According to the ProPublica report, the FDA has been aware of the risk of acetaminophen liver damage for more than 30 years. In 1977, an expert panel recommended a “severe liver damage” warning for Tylenol, but this wording was not added to product labels for decades.

ProPublica also claims that McNeil directly opposed multiple safety warnings and restrictions that would have made the medication safer for consumers, even going so far as to oppose informational campaigns proposed to help educate the public about the dangers of liver damage from acetaminophen. In other cases, however, the company was known to implement new warnings before they were required by the FDA.

Johnson & Johnson recently added a new “red cap warning” to Extra Strength Tylenol bottles encouraging users to read all safety labels and warnings distributed with the product.

Drugs containing acetaminophen, like Tylenol, NyQuil, Excedrin, and Sudafed, are amongst the most commonly used medications in the United States. Despite recent efforts to raise awareness about acetaminophen liver damage, some estimate that up to one-quarter of users take more than the recommended dose.

A number of individuals have filed personal injury lawsuits against Tylenol and other makers of acetaminophen products based on claims that they were not sufficiently warned about the risk of liver damage with this drug. If you suffered liver damage after taking an acetaminophen product and would like to learn more about Tylenol liver lawsuits, contact Berkowitz and Hanna LLC for a free legal consultation.