An FDA advisory panel has voted 21-0 in favor of adding dosing instructions to Children’s Tylenol and other products containing acetaminophen for children between 6 months and 2 years.
Currently, the liquid formulas do not contain dosing information for children under 2. Panel members said the lack of information can lead parents to give their kids an incorrect dose of the drug.
Acetaminophen-related overdoses are most common among children younger than 2, and have increased over the past decade, according to FDA data. While safe when used as directed, acetaminophen has long been subject to warning labels because it can cause serious and even fatal liver damage when overused.
Dosing errors with children’s acetaminophen products accounted for 7,500 of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.
Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.
The panel also voted unanimously that medicines should include dosing information based on children’s weight, and to limit cup measurements to milliliters, because having both teaspoon and milliliter markings can cause confusion.
The proposed changes have been discussed at FDA meetings since the mid-1990s. FDA is not required to follow the recommendations of its advisory panels, though it often does.
Source: Associated Press