Johnson & Johnson, the manufacturer of Tylenol, will soon put a warning on the popular pain reliever. Tylenol sold in the United States will now bear red warnings alerting users to the potentially fatal risks of taking too much of the drug. The unusual step, disclosed by Johnson & Johnson, comes amid a growing number of lawsuits and pressure from the federal government. It 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 each new bottle of Extra Strength Tylenol sold in the United States beginning this month.
The warning will be put on most other Tylenol bottles in coming months. The warning will make it clear that the over-the-counter drug contains acetaminophen. As we have reported in previous issues, acetaminophen, a pain-relieving ingredient, is the nation’s leading cause of sudden liver failure. The new cap is designed to grab the attention of people who don’t read warnings that already appear in the fine print on the product’s label, according to Johnson & Johnson.
Overdoses from acetaminophen send 55,000 to 80,000 people to the emergency room in the United States each year and kill at least 500, according to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Acetaminophen can be found in more than 600 common over-the-counter products used by nearly one in four American adults every week, including household brands like Nyquil cold formula, Excedrin pain tablets, and Sudafed sinus pills. “We’re always looking for ways to better communicate information to patients and consumers,” says Dr. Edwin Kuffner, vice president of McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol.
Tylenol is the first of these products to include such a warning label on the bottle cap. According to McNeil, the warning is a result of research into the misuse of Tylenol by consumers. The new cap message will read: “CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL.” The move comes at a critical time for the company, which faces more than 85 personal injury lawsuits in federal court that blame Tylenol for liver injuries and deaths.
At the same time, the FDA is drafting long-awaited safety measures that could curtail the use of Tylenol and other acetaminophen products. Much is at stake for McNeil and its parent company. While Johnson & Johnson does not report sales of Tylenol, it should be noted that total sales of all over-the-counter medicines containing acetaminophen were more than $1.75 billion last year. This is 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 it’s reported that some pharmacies don’t even stock regular strength. Most experts agree that acetaminophen is safe when used as directed, which generally means taking less than 4,000 milligrams, or eight pills of Extra Strength Tylenol, a day.
Each year, some 100 million Americans use acetaminophen, but liver damage occurs in only a fraction of 1 percent of users. While that percentage is small, it still means about one million users will have liver damage. Liver specialists say those cases are preventable. They say that part of the problem is that there are sometimes hundreds of pills in a bottle, making it easy for consumers to take as many as they please. For example, McNeil sells Extra Strength Tylenol in bottles containing up to 325 tablets. Dr. William Lee of the University of Texas Southwestern Medical Center, who has studied acetaminophen toxicity for four decades, had this to say:
The argument goes that if you take acetaminophen correctly you will virtually never get into trouble. 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.
While Dr. Lee applauded the new warning, he said McNeil’s marketing has contributed to the “freewheeling” way that Americans take the drug. For decades, McNeil has advertised Tylenol as “the safest brand 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,” Dr. Lee says. But Dr. Kuffner as expected takes the company line, saying:
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.
Most likely folks won’t stop buying Tylenol, but at least they will have been warned that there is a risk when taking the pain medicine. Consumers will have to weigh the benefits against the risk associated with taking Tylenol.
Source: Associated Press
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