Tylenol Warnings About Overdoses Added to Labels: What You Should Know
For years, consumers, physicians and "Dr. Mom" assumed that Tylenol was the safest option for easing pain caused by common conditions such as headaches, backaches, flu and colds. And then came the news reports that this supposedly "safe" over-the-counter pain reliever actually could cause potentially life-threatening problems. Now, faced with pressure from the federal government and lawsuits, Tylenol manufacturer Johnson & Johnson is adding red warnings to make consumers aware of the potentially deadly risks of overdosing, reported the Christian Science Monitor on August 29.
Johnson & Johnson has decided to place the new warnings on Extra Strength Tylenol caps that are sold in the U.S. starting in October. They also will add the warnings to the majority of their other Tylenol products this coming year. Included in the warning: Clarification that Tylenol contains acetaminophen, which both relieves pain and ranks as the nation's leading cause of sudden liver failure.
"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.
Emergency Room Alerts
Think it can't happen to you? Overdoses from acetaminophen send 55,000 to 80,000 people in the U.S. to the emergency room each year, with at least 500 dying from overdoses, according to the Centers for Disease Control and Prevention and the Food and Drug Administration. In addition to Tylenol, acetaminophen is present in more than 600 over-the-counter and prescription products used by nearly one in four American adults every week. Examples include Nyquil cold formula, Excedrin pain tablets and Sudafed sinus pills.
Tylenol's label, in an attempt to reduce those numbers, will highlight this message: "CONTAINS ACETAMINOPHEN" and "ALWAYS READ THE LABEL."
Currently more than 85 personal injury lawsuits are in federal court linking Tylenol for liver injuries and deaths. In addition, the Food and Drug Administration is creating safety proposals that could curtail the use of Tylenol and other acetaminophen products.
Extra Strength Extra Dangerous
In particular, experts are worried about "extra-strength" versions of Tylenol and other pain relievers with acetaminophen found in drugstores. While regular strength has 650 milligrams, a standard two-pill dose of Extra Strength Tylenol contains 1,000 milligrams of acetaminophen. How popular is it? Some pharmacies don't even sell regular strength.
So how much is safe? Experts surveyed by the Christian Science Monitor termed acetaminophen as safe when used as directed, which generally means taking 4,000 milligrams, or eight pills of Extra Strength Tylenol or less, a day.