The FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee have together recommended that “pain relief” be removed from the label of Tylenol and other brands of acetaminophen because there is no reliable evidence that it relieves pain better than placebo in children under age two.
This will surprise many parents who reach for these common pain relief drops when their little ones are teething or have an earache or a sore throat. Not surprisingly, the over-the-counter drug industry trade group (CHPA) objects to the findings of the expert panel.
Tylenol Does Reduce Fever – But Why?
The advisory panel recommended that the acetaminophen label should say it’s for “fever reduction” and nothing else. But here’s the thing – in most cases the fever is helping the child by activating the immune system and fighting the infection. I don’t recommend treating fever unless it is interfering with a child’s ability to sleep or to drink liquids (both are even more important for healing than the fever).
If we don’t give acetaminophen to babies and toddlers for pain, and we rarely give it for fever – this will change the landscape of over-the-counter medications for young children.
Tylenol Is Not As Benign As Many People Think
Acetaminophen is the most common cause of acute liver failure in the US. It has been estimated to cause three times as many cases of liver failure as all other drugs combined. While the serious problems usually come from overdoses, in babies and small children the dose that can cause harm may be not many times more than the recommended dose.
Tylenol Dosing Should Be Based on Weight
Most dosage charts that parents see list a dose based on age, or suggest that parents ask a doctor for the dose. And dosage concentrations have varied in various formulations. Together, this confusion has led to overdosing and to fatalities in several dozen healthy young children over the last decade.
The FDA panel has recommended that all liquid acetaminophen come in the same concentration, that all packages contain dosing information for children down to 6 months of age, and that the dose be based on the child’s weight.
FDA Advisory Committee Meeting Minutes
FDA Meeting Transcript: Day One
FDA Meeting Transcript: Day Two
OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions May 18, 2011.
Lee WM. “Drug-Induced Hepatotoxicity.” New England Journal of Medicine, July 31, 2003, 349:474-485