New Dosage Instructions Sought For Children's Tylenol and Acetaminophen Products

As a parent of a young daughter, I know firsthand the stress and fear of a rising fever that just won’t break and how much we rely on basic medications like Tylenol and other acetaminophen drugs. Fortunately, we have a pediatrician we like very much who on our very first visit imparted the "super secret" dosage instructions for children under two years old.

But why was this information "super secret"? If you’re child is burning with fever at 2 a.m., you’re not able to "ask your doctor" about the appropriate dosage for your child without an expensive trip to the emergency room.

The FDA reported it had 14 fatal and 74 non-fatal "adverse events" related to acetaminophen medication errors in infants and children from 2000 to 2010.

FDA advisory committees and acetaminophen makers (including Tylenol) are finally working to fix that problem.

The FDA committees have recommended the following changes to make dosing these medicines easier and to help parents prevent accidental overdoses:

• Dosing instructions will be given for both age and weight
• Improving labels to make them less confusing
• Standardizing measuring units
• Providing a single concentration of the medicines to avoid accidental overdoses of a higher concentrated formula

Just weeks ago, Tylenol maker Johnson & Johnson along with other acetaminophen makers Perrigo Co. and Novartis AG, agreed to voluntarily discontinue the more-concentrated formula used for infant acetaminophen products. The FDA had recommended a single concentration formulation since 2009.

When administering any drug to your child, be sure to read the dosing instructions carefully. When in doubt, contact your physician.

[More on Johnson & Johnson]

Learn More:

• Clearer kids’ dosing urged for acetaminophen-containing meds [Caitlin Hagan at CNN]
• Panel Calls for Label Changes on Acetaminophen Products [Jennifer Corbett Dooren at WSJ]

(c) Copyright 2011 Brett A. Emison