September 26, 2013 — ProPublica has published an investigative report linking Tylenol (acetaminophen) to at least 1,567 deaths from accidental overdoses in the last decade, and they warn that decades of regulatory inaction is to blame.

Investigators found that about 150 Americans died from accidental Tylenol overdoses each year between 2001 and 2010. During the same time, drug-makers Johnson & Johnson and McNeil earned over $1.5 billion in worldwide revenue, while spending $100 million per year on advertisements.

The ads implied safety and superiority of Tylenol while never actually using the word “safe” — with slogans like “The pain reliever hospitals use most” and “The one more pediatricians give their own children.”

Experts have been warning about the risk of liver injury from Tylenol since the 1970s, but it took the FDA over 30 years to require drug-makers to strengthen warnings. Accoriding to ProPublica investigators:

“Over more than three decades, the company repeatedly fought against safety warnings, dosage restrictions and other measures meant to safeguard users of the drug, according to company memos, court records, documents obtained under the Freedom of Information Act, and interviews with hundreds of regulatory, corporate and medical officials.”

The organization suggests reducing the amount of acetaminophen per pill, reducing the maximum daily dose, and removing acetaminophen from prescription painkillers like Vicodin and Percocet.

They also recommended stronger warnings about the risk of liver damage to increase consumer awareness about the risk of liver damage. Prescription Tylenol products already have a “Black Box Warning” that overdoses can lead to liver failure, liver transplant, or death. However, over-the-counter Tylenol products are not required to carry such warnings.