Know Concentration Before Giving Acetaminophen to Infants February 12, 2012

The Food and Drug Administration is asking parents and caregivers to carefully read the labels of liquid acetaminophen marketed for infants to avoid dosage errors with their children.

The warming comes as a less concentrated form of this popular medication arrives on store shelves. Giving an incorrect dose of acetaminophen can cause the medication not to work if too little is given or it can cause serious side effects and even death if too much is given.

An April 2011 report from FDA’s Center for Drug Evaluation and Research found that confusion over the different liquid concentrations for infants and children was leading to overdoses that caused some infants to be seriously ill, and some to die from liver failure.

To prevent these dosing errors, some manufacturers have 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 marketed for children, which is 160 mg per 5mL. This less concentrated  acetaminophen marketed for infants now has new dosing instructions and may even have a new dosing device in the box, such as an oral syringe.

Until now, liquid acetaminophen for infants has only been available in a stronger concentration that doesn’t call for giving as much liquid with each dose.

But both concentrations of liquid acetaminophen are now in circulation. Before giving the medication to children, parents and caregivers should check to see which version they have. The FDA is concerned that infants could be given too little or too much of acetaminophen if the different concentrations of the medication are confused.

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

Parents and caregivers should follow this advice from FDA:

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

If a pediatrician prescribes a 5 mL dose of the less concentrated acetaminophen, but the parents give a 5 mL dose of the more concentrated version, the child can receive a potentially fatal overdose, said Holquist.
Likewise, if a physician prescribes a dose based on the more concentrated acetaminophen and the less concentrated medication is used, the child might not get enough medication to fight a fever, she says.

Adding to this confusion is the fact that the box and bottle may look much the same for old and new versions of the medication, Holquist says.

Read the Drug Facts label on the medication to determine the difference between the two liquid acetaminophen products:

• Look for the “Active ingredient” section of the Drug Facts label usually printed on the back of the medication package.
• If the package says “160 mg per 5 mL” or “160 mg (in each 5 mL)”, this is the less concentrated acetaminophen. This medication should come with an oral syringe to help you measure the liquid dose.
• If the package says “80 mg per 0.8 mL” or “80 mg per 1 mL,” this is the more concentrated version. This product may come with a dropper.

If the dosing instructions provided by your pediatrician or healthcare provider are different from what is on the label, check with them or another healthcare professional before giving the medication. Do not rely on dosing information from other sources such as family members, old dosing charts or the Internet.

Parents and caregivers should also realize there is no dosing amount specified for children under 2. If your infant or child is 2 years old or younger, always get dosing instructions from your healthcare provider. Acetaminophen is marketed for infants under brand names such as Pedia Care Fever Reducer Pain Reliever, Little Fevers Infant Fever/Pain Reliever,  and Triaminic Infants’ Syrup Fever Reducer Pain Reliever. Store brands are also available on shelves.

For more on child safety issues,  see the library of articles by Daytona Beach child accident attorney.