The Food and Drug Administration (FDA) is urging consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their children.
A less concentrated form of the popular medication is arriving on store shelves, and giving the wrong dose of acetaminophen can cause the medication to be ineffective if too little is given or cause serious side effects and, possibly, death if too much is given.
In an attempt to reduce the confusion over different strengths that have been blamed for past overdoses, some manufacturers are voluntarily offering only the less concentrated version for all children.
Until now, 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.
Both concentrations
But currently, both concentrations of liquid acetaminophen are in circulation. Before giving the medication, parents and caregivers need to know whether they have the less concentrated version or the older, more concentrated medication. FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused.
“Be very careful when you’re giving your infant acetaminophen” says Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis.
Here’s what the agency wants parents and caregivers to do:
- 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.
Overdosing a serious risk
An April 2011 report from FDA’s Center for Drug Evaluation and Research (CDER) found that confusion caused by the different concentrations of liquid acetaminophen for infants and children was leading to overdoses that made infants seriously ill, with some dying from liver failure.
So to avoid dosing errors, some manufacturers voluntarily changed the liquid acetaminophen marketed for infants 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.
But this is a voluntary change and some of the older, stronger concentrations of acetaminophen marketed for infants are still available and may remain available.
“There is still some on store shelves; there is still some in homes; and there is still some in distribution,” says Holquist.
