During the last decade, more than 1,500 Americans have died from accidental overdose of acetaminophen, the active ingredient in Tylenol, ProPublica reports. Tylenol, manufactured by Johnson and Johnson, is one of the most popular pain relievers in the US.
While acetaminophen is generally considered safe when taken in recommended doses, the drug can damage and even destroy the liver when taken in excess, or when taken with alcohol. Tylenol liver damage is a significant health problem that has caused both nonfatal and fatal injuries in people as young as five months old.
The US Food and Drug Administration has long recognized the potential risks of acetaminophen – studies have shown that the margin between a safe amount of the drug and the amount that can cause serious harm is narrow, more so than other pain relievers.
For over three decades, federal regulators have neglected to adopt measures to address the number of deaths and injuries from acetaminophen. Yet, the agency has called deaths from liver damage resulting from acetaminophen “a persistent, important public health problem.”
Manufacturer McNeil Consumer Healthcare, a subsidiary of Johnson and Johnson, helped to fund the development of an antidote to acetaminophen poisoning, which has helped save lives, but the company “repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug,” according to ProPublica.
“The FDA changed the Tylenol label in 2011, and changed the dosage for each tablet to contain 325 mg as opposed to what they were before, so back in 2009, 2010, 2011, even today, some people are taking a higher-than-recommended dose of Tylenol because the labels are still being changed as we speak,” said Megan McBride, an associate attorney with the Levin, Papantonio law firm, who practices in the areas of bad drug and defective medical device litigation.
Recent reports have even suggested that Tylenol can be used to treat anxiety. “Johnson and Johnson and its subsidiary, McNeil, have promoted this drug for literally decades as being one of the safest drugs in the world… but the reality is, acetaminophen has been known for years to be extraordinarily toxic, especially to the liver,” said Troy Rafferty, a shareholder with the Levin, Papantonio law firm.
During the past few years, a number of lawsuits have been filed by individuals who experienced liver damage from Tylenol. Many consumers allege that they, or a family member, suffered injury or death as a result of taking Tylenol at or near the maximum recommended dose.