September 26, 2013 — Investigative reporters with the consumer-advocacy group ProPublica have found that accidental overdoses of Tylenol (acetaminophen) are responsible for 1,567 deaths between 2001 and 2011.
During the same time period, prescription and over-the-counter Tylenol products generated over $1.5 billion a year in revenue for Johnson & Johnson & McNeil. The companies spent about $100 million per year on advertisements that promoted Tylenol as superior to other painkillers.
The first studies linking Tylenol and liver damage were published in the 1970s. It took the FDA over 30 years to require drug-makers to strengthen warnings about the danger. Today, polls indicate a lack of consumer awareness about the risk of Tylenol overdoses, and injury statistics indicate that the problem has been getting worse for decades.
ProPublica investigators warned:
“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 made several suggestions to reduce the number of accidental overdoses. At least 10 countries (Australia, New Zealand, Germany, Finland, Denmark, Switzerland, Sweden, and more) have passed laws restricting sales of the drug, such as limiting the amount of Tylenol that customers can purchase at one time or requiring pharmacies to dispense the product.
They also suggested reducing the maximum recommended daily dose of acetaminophen, removing acetaminophen from prescription opioid painkillers (Vicodin, Percocet, etc.), reducing the amount of acetaminophen per pill (especially Extra Strength Tylenol), and strengthening warnings to increase consumer awareness about the problem.