WASHINGTON -- Bottles of Tylenol sold in the United States will soon bear red warnings alerting users to the potentially fatal risks of taking too much of the popular pain reliever.
The unusual step, disclosed by the company that makes Tylenol, comes amid a growing number of lawsuits and pressure from the federal government that could have widespread ramifications for a medicine taken by millions of people every day.
Johnson & Johnson says the warning will appear on the cap of new U.S.-sold bottles of Extra Strength Tylenol starting in October, and on most other Tylenol bottles in coming months. The warning will make it explicitly clear that the over-the-counter, or OTC, drug contains acetaminophen, a pain-relieving ingredient that is the nation's leading cause of sudden liver failure.
"We're always looking for ways to better communicate information to patients and consumers," says Edwin Kuffner, vice president of McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol.
Overdoses from acetaminophen send 55,000 to 80,000 people in the United States to emergency rooms each year and kill at least 500, the federal Centers for Disease Control and Prevention and the Food and Drug Administration say. Acetaminophen can be found in more than 600 over-the-counter and prescription products used by nearly 1 in 4 American adults every week, including household brands such as Nyquil cold formula, Excedrin pain tablets and Sudafed sinus pills.
Tylenol is the first of these products to include a bottle-cap warning label. McNeil says the warning is a result of research into consumers' misuse of Tylenol. The new cap message will read: "CONTAINS ACETAMINOPHEN" and "ALWAYS READ THE LABEL."
The move comes at a critical time, with McNeil facing more than 85 federal court personal-injury lawsuits blaming Tylenol for liver injuries and deaths. At the same time, the Food and Drug Administration is readying long-awaited safety proposals that may curb use of Tylenol and other acetaminophen products.
Much is at stake for McNeil and its parent. Johnson & Johnson does not report Tylenol sales, but total sales of all over-the-counter medicines containing acetaminophen were more than $1.75 billion last year, according to Information Resources Inc., a retail data service.
Safety experts are most concerned about "extra-strength" versions of Tylenol and other pain relievers with acetaminophen found in drugstores. A typical two-pill dose of Extra Strength Tylenol contains 1,000 milligrams of acetaminophen, compared with 650 milligrams for regular strength. Extra Strength Tylenol is so popular that some pharmacies don't even stock regular strength.
Most experts agree that acetaminophen is safe when used as directed -- generally 4,000 milligrams, or eight Extra Strength Tylenol pills or fewer, a day.
Each year, some 100 million Americans use acetaminophen, but liver damage occurs in only a fraction of 1 percent of them. Still, liver specialists say those cases are preventable. Part of the problem, they say, is that there are sometimes hundreds of pills in a bottle, so consumers can easily pop as many as they please. For example, McNeil sells Extra Strength Tylenol in bottles containing as many as 325 tablets.
"The argument goes that if you take acetaminophen correctly, you will virtually never get into trouble," says William Lee at the UT Southwestern Medical Center, who has studied acetaminophen toxicity for four decades. "But it's the very fact that it's easily accessible over-the-counter in bottles of 300 pills or more that puts people in harm's way."
Dr. Lee applauded the new warning, but said McNeil's marketing has contributed to the "freewheeling" way Americans take the drug. For decades, McNeil has advertised Tylenol as "the safest kind of pain reliever" when used as directed. "That has been their standard ploy in the past, and I would argue that safest it is not," he says.
McNeil is the only major drugmaker adopting the bottle cap warning at this time, said the Consumer Healthcare Products Association, a trade group for OTC medicine companies. McNeil has updated Tylenol safety warnings periodically since the 1990s. In 1994, it added a warning about liver damage risk when combining alcohol with Tylenol, after a lawsuit brought by Antonio Benedi, an aide to former President George H.W. Bush, who fell into a coma and underwent an 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 of the risk. The FDA in 1998 made the alcohol warning mandatory for all acetaminophen manufacturers.
Then, in 2002, an expert panel of FDA advisers urged the government agency to require that all acetaminophen products carry a warning about the "severe liver damage" risk 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.
In 2009, another FDA expert panel considered more sweeping changes to reduce acetaminophen overdoses. It urged a half-dozen major changes, including lowering the maximum nonprescription daily dose for adults. McNeil voluntarily adopted that recommendation, lowering the recommended Extra Strength Tylenol adult dose to 3,000 milligrams per day, or six pills, down from 4,000 milligrams per day, or eight pills. The label says patients can still take a higher dose under doctor's directions.
But the company has not embraced a more drastic FDA expert panel recommendation: eliminating the OTC "extra-strength" formulation altogether, which would mean lowering the acetaminophen dose from 1,000 milligrams to 650 milligrams, or two tablets of 325 milligrams each. The panel said the 1,000 milligram dose should only be available via prescription.