McNeil’s Kuffner stands by the company’s safety claim: “When taken as directed, when people read and follow the label, I believe that Tylenol and the acetaminophen ingredient is one of the safest pain relievers on the market.”
McNeil is the only major drugmaker adopting the bottle cap warning at this time, according to the Consumer Healthcare Products Association, a trade group for over-the-counter medicine companies.
“While this is not an industrywide initiative at this time, it fits squarely within the many ongoing industrywide educational initiatives to further acetaminophen safe and responsible use by consumers,” said Emily Skor, a vice president with the trade group, which represents McNeil, Bayer Healthcare, Procter & Gamble and other nonprescription drugmakers.
20 YEARS OF WARNINGS
McNeil has updated the safety warnings on Tylenol periodically since the 1990s.
In 1994, the company added a warning about the risk of liver damage when combining alcohol with Tylenol following a lawsuit brought by Antonio Benedi, a former aide to President George H.W. Bush, who fell into a coma and underwent emergency liver transplant after mixing Tylenol with wine at dinner.
A jury awarded him $8.8 million in damages after concluding that McNeil failed to warn consumers about the risk. The FDA made the alcohol warning mandatory for all manufacturers of acetaminophen in 1998.
Then, in 2002, an expert panel of FDA advisers recommended that the government agency require all acetaminophen products to carry a warning about the risk of “severe liver damage” when not taken as directed. The group’s votes are non-binding, though the FDA usually follows them. McNeil voluntarily added the warning to its products in 2004, five years before the FDA made it mandatory.
Today, McNeil appears to be moving ahead of regulators again. In 2009, the FDA assembled another expert panel to consider more sweeping changes to reduce acetaminophen overdoses. The panel recommended a half-dozen major changes, including lowering the maximum nonprescription daily dose for adults. McNeil voluntarily adopted that recommendation, lowering the recommended adult dose of Extra Strength Tylenol to 3,000 milligrams per day, or six pills of Extra Strength Tylenol, down from 4,000 milligrams per day, or eight pills. The label stipulates that patients can still take a higher dose under doctor’s directions.