Should We Trust Tylenol?

When Tylenol was first introduced in 1955 it was a liquid prescription pain reliever and fever reducer for children. It wasn't until 1961 that Tylenol tablets were launched as over-the-counter pain pills for adults.

Tylenol and its active ingredient acetaminophen (APAP) was promoted as a safer alternative to aspirin. A prominent gastroenterologist, Dr. James Roth, had been traveling the country speaking about the dangers of aspirin for a number of years before McNeil introduced Tylenol. With an alternative analgesic that was less likely to cause stomach upset and bleeding, the company engaged Dr. Roth's services as a consultant.

From the beginning, then, Tylenol (and by implication acetaminophen) has been presented to the public as super safe. During the 1980s the company ran commercials emphasizing the phrase "trust Tylenol." One familiar refrain went, "Tylenol is the pain reliever hospitals use most. I can't think of a better reason to trust Tylenol."

In one commercial, the spokesperson was pictured as an aerobics instructor who took good care of herself by jogging and watching what she ate. She asserted that she was just as careful about her pain reliever, and implied that is why she chose Tylenol.

The ad campaign was extremely effective. More than twenty years later health professionals and patients alike often assume that acetaminophen is much safer than other pain relievers. That's primarily because it is less likely to irritate the digestive tract. To this day, most people don't think twice about possible hazards of nonprescription acetaminophen.

The FDA thinks that should change. This spring the agency determined that labeling for nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen or naproxen should be changed to highlight the risk of stomach bleeding from these pain relievers.

But acetaminophen won't get off without its own beefed-up warning. The FDA will require the labels of acetaminophen products to caution users about the risk of severe liver damage.

Although liver toxicity from high doses of acetaminophen has been recognized for decades, most Americans don't appreciate the severity of the problem. When drugs damage the liver, health is compromised. Once the injury begins, stopping the medication may not be enough to reverse the process. From 1998 through 2003, acetaminophen was implicated as the leading cause of acute liver failure in the U.S. (Hepatology, Dec. 2005).

The FDA is talking about reducing the maximum daily dose from 4,000 mg to 3,250 mg. People who regularly consume alcohol should probably take even less.

Unintentional overdose is not uncommon because acetaminophen is found in so many different kinds of products, from cough and cold remedies to nighttime sleep aids.

Readers who are feeling apprehensive about daily use of over-the-counter pain relievers for aching joints may find our Guide to Alternatives for Arthritis a welcome option. It contains a number of non-drug approaches as well as a discussion of the pros and cons of medications.

With more than 20 million Americans swallowing pain pills every day, it's high time we paid more attention to their potential hazards.