Panel urges acetaminophen dosage directions for those under 2
SILVER SPRING, Md. — Federal health experts said yesterday that dosing instructions for children younger than 2 years old should be added to Children’s Tylenol and similar products containing acetaminophen, the popular pain reliever and fever reducer.
A panel of Food and Drug Administration advisers voted 21-0 in favor of adding doses for children 6 months to 2 years old to acetaminophen formulas. The FDA has convened a two-day meeting to consider changes designed to make the formulas safer and easier to use.
The liquid formulas have never contained dosing information for children under 2 to avoid an overdose and to encourage parents to seek medical attention for sick infants. Fever in children younger than 6 months can be associated with dangerous infections, like meningitis and pneumonia.
The FDA’s panelists said the lack of information contributes to confusion and can lead parents to incorrectly dose children. Acetaminophen-related overdoses, most common among children younger than 2, have increased over the past decade, according to FDA data.
Acetaminophen is among the mostly widely used drugs in the United States, sold in hundreds of formulations and combinations with other ingredients. The meeting yesterday dealt with a small group of single-ingredient products, including J&J’s Children and Infants’ Tylenol, Novartis’ Triaminic, Prestige Brands’ Little Fevers, and various drugstore brands.
While safe when used as directed, acetaminophen has long been subject to warning labels because it can cause liver damage when overused. Dosing errors with children’s acetaminophen products accounted for 7,500, or 2.8 percent, of the 270,165 emergencies reported last year, according to the American Association of Poison Control Centers.
Panelists supported the FDA and manufacturer’s efforts to improve labeling for the products, but some pointed out that the proposed changes have been discussed at FDA meetings since the mid-1990s.
“It’s 16 years later, and we still don’t have a clear and effective label for this product,’’ said Amy Celento, the panel’s patient representative. “This is taking far too long — we can’t go the way of offshore drilling and wait until a disaster before we make necessary changes.’’