The FDA's Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Meeting met over the last few days.
As expected, the panel voted in favor of requiring manufactures of Tylenol (acetaminophen) to add dosing instructions for infants over age six months. Currently, these pain and fever reducers only have a dose for children who are at least two years of age, and suggest that parents call their doctor for a dose for younger children. Unfortunately, that creates confusion, as some parents simply estimate a dose for infants and toddlers when their child needs Tylenol and they don't have access to their doctor.
The FDA panel also recommended that dosing be based primarily on a child's weight. While dosing labels do include weight recommendations right now, it is right next to age based recommendations, with no guidance on what to do if the recommendations don't agree, for example if your three year old weighs more than the age-associated weights listed, which haven't been updated in 20 years.
