In what appears to be a move ahead of a Food and Drug Administration (FDA) directive to do same, the makers of Tylenol have decided to place even more warnings about the product on the caps of bottles of the popular pain reliever. In fact, the two additional warnings are obvious and direct: They’re red and written in capital letters.
The Tylenol warnings are most likely Johnson & Johnson playing preventive defense before the FDA forces the company to label the pain reliever alerting consumers to its acetaminophen content. The Associated Press reported (via Yahoo News) Aug. 29 that the company will roll out bottles of Extra Strength Tylenol in October with caps with red lettering emblazoned upon them saying “Contains Acetaminophen” and “Always Read The Label.” Other versions of the pain reliever will see similar cap warnings in the coming months.
McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, appears to be pre-empting not only probable decisions by the FDA but also the potential negative backlash from lawsuit decisions concerning Tylenol users that allege that their taking of Tylenol, even though they followed the label directions, resulted in sudden liver failure — a condition that is fatal without a transplant.
There are currently 85 cases against Tylenol and its parent company, nearly all of which involve a claim that the plaintiff allegedly took the pain reliever as directed and still suffered catastrophic liver damage. Some cases involve deaths.
The Centers for Disease Control and Prevention as well as the FDA note that between 55,000 and 80,000 people visit emergency rooms in the U. S. due to acetaminophen overdoses. Some 500 people die each year from said overdoses. About half of those are accidental overdoses (the other half: suicides).
RxList.com notes that there are 1,600 cases of sudden liver failure each year.
But Tylenol isn’t the only product containing acetaminophen. Over 600 over-the-counter and prescription products contain at least some acetaminophen. One-fourth of all Americans take at least one of these products each week. Tylenol will be the first of all of those products to display that it contains acetaminophen.
With acetaminophen linked to sudden liver failure and the amount that might be dangerous undetermined and apparently individualistic, directing the consumer to follow certain dosages could result in a harming the consumer.
Experts believe that when Tylenol is taken as directed, it is relatively safe. This requires that the consumer take only up to 4,000 mgs per day.
In 2004 McNeil voluntarily added the warning that taking Tylenol produced the risk of “severe liver damage.”
This is the second labeling change that Tylenol had undergone this year. The FDA ruled that all products containing acetaminophen were required to have a “black box warning,” the strongest labeling warning. The FDA announced the requirement after acetaminophen was linked to a rare but deadly skin disease produced by an adverse reaction to the active ingredient found in numerous pain relievers and prescription products.