Acetaminophen Liver Damage Warning Added to Tylenol Caps

September 3, 2013 — The Associated Press reports that Johnson & Johnson will be adding new red warnings to the cap on Tylenol (acetaminophen) products to alert users about the potentially fatal risk of overdoses. The company is facing increased pressure from over 85 Tylenol liver damage lawsuits in federal court.

The new red cap will read: “CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL.” Bottles of Extra Strength Tylenol will carry the warnings starting in October and most other Tylenol products in the next few months.

The move is intended to curb overdoses, which send 55,000 – 80,000 Americans to the emergency room every year and kill at least 500. About half of the deaths are accidental.

The problem is that many Tylenol users underestimate the risk of liver damage. Tylenol was marketed for decades as “the safest kind of pain reliever” and is available in high doses over-the-counter. Although most experts agree Tylenol is safe when taken as directed, even small overdoses can have life-threatening consequences. Patients who develop liver failure after a Tylenol overdose generally have 24 – 48 hours to live without a transplant.

Furthermore, bottles of Extra Strength Tylenol can contain hundreds of pills, making it tempting to pop multiple pills at a time. About 600 products contain acetaminophen, including Nyquil, Excedrin, Sudafed, and more. About 60% of unintentional overdoses involve prescription products containing acetaminophen, such as Percocet and Vicodin.

Johnson & Johnson is accused of downplaying the risks of Tylenol overdoses and failing to warn about liver damage. Experts have known about the risk of liver damage from Tylenol since the 1970s. However, it was not until the 1990s that the company began adding warnings, and only after a lawsuit was filed by Antonio Benedi, a man who suffered liver failure after mixing Tylenol with wine at dinner. In 2004, warnings about “severe liver damage” were added to the label. In 2011, the maximum daily dose of Tylenol was lowered to 3,000-mg per day, or six pills of Extra Strength Tylenol.