On Wednesday, health advisors unanimously recommended that pediatric doses of acetaminophen be based on children’s weight. The panel advised the Food and Drug Administration (FDA) that a child’s weight is the most accurate way to determine the proper dose. The advisers noted most over-the-counter manufacturers include dosing tables with both weight and age, but emphasized weight is the preferred method.
The panel also recommended that dosing instructions be added to labels of fever reducing medication for children under the age of 2. The Associated Press reported that in a 21-0 vote, the panel called for adding dosing instructions for children 6 months to 2 years old to medicines such as Children’s Tylenol and similar products. Currently, these labels only include children age 2 and up. Labels for kids under 2 only advise parents “to ask a doctor.”
The lack of specific dosing instructions can lead to confusion, said the FDA advisers, with parents unintentionally giving their children under 2 too much medicine. The FDA reported that, “acetaminophen-related overdoses are the most common among children under the age of 2 and have increased over the past decade.”
Dosing information for children’s medication containing acetaminophen has developed significantly since being introduced in the 1970s. According to drug maker, McNeil Consumer Healthcare, labels were “somewhat crude as children 12 and up were advised to take the adult dose, kids 6 to 12 were told to take half that, and kids younger than 6 were told to take a quarter of the adult dose.”
According to the American Association of Poison Control, in 2010, there were 270,000 reported overdoses of acetaminophens while dosing errors accounted for 7,500, or 3 percent, of those cases. Pediatricians advise parents that acetaminophens are safe for children but too much can be toxic and cause liver failure.
Although doctors often prescribe acetaminophens for pain relief, the panel lacked evidence to support the labeling instruction for children under the age of 2, reported the Associated Press.
The panel also advised the FDA on requiring liquid acetaminophen bottles to come with a measuring device marked in milliliters using the standard “mL” abbreviation and that all solid, pill forms of acetaminophens for children come in the same concentration.
The Consumer Healthcare Products Association, an industry trade group, voluntarily agreed to sell only one concentration of liquid acetaminophens in products for infants and children. This will remove the more concentrated infant drops from the market. “For example, Infant’s Tylenol liquid drops were much more concentrated than Children’s Tylenol,” says the Associated Press, “which could easily lead to confusion if parents didn’t read the label or know there was a difference.”
The multiple concentrations will be phased out starting in the middle of this year.
