FDA Warns of Changes in Infant Acetaminophen Dosage

In an effort to reduce accidental overdoses that occur in infants given acetaminophen products, manufacturers have reduced the concentration of pain and fever reducing medications, causing new dosage requirements, unbeknownst to many parents.

While the old formulas meant giving smaller liquid doses of the product, infants were often given too much, causing overdoses, and in some cases death. The new formulations, which are on many store shelves along with the old, require different dosages, mitigating the chances of liver damage. But parents may not be reading labels and underdosing their children, which means the product will not be effective.

According to the FDA, until recently, liquid acetaminophen marketed for infants has only been available in a stronger concentration that doesn’t require giving the infants as much liquid with each dose. But right now both concentrations of liquid acetaminophen are in circulation.

The FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused. They caution parents and caregivers to be on the alert and know which formulation they are using.

“Be very careful when you’re giving your infant acetaminophen” says Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis.

The liquid acetaminophen marketed for infants has changed from 80 mg per 0.8mL or 80 mg per 1 mL to be the same concentration as the liquid acetaminophen marketed for children—160 mg per 5mL. This less concentrated liquid acetaminophen marketed for infants now has new dosing directions and may have a new dosing device in the box, such as an oral syringe.

Specifically, the FDA recommends parents and caregivers to do the following:

• Read the Drug Facts label on the package very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
• Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
• Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
• Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration.