Acetaminophen Alert from the FDA

With two different concentrations of infant acetaminophen now on the market, the FDA has issued an important safety announcement to parents. We featured an article last month in our weekly highlights but thought it worth calling out specifically.

Infant acetaminophen has traditionally come in a stronger concentration than children’s acetaminophen so that less liquid had to be offered in a single dose. But an April 2011 report from the FDA Center for Drug Evaluation and Research found that some infants were suffering from overdoses, some dying of liver failure, due to confusion over the different concentrations for infants and children.

In an effort to standardize the medicine for all children under 12, manufacturers have chosen to change the infant concentration to the same as that offered for children which means more liquid will need to be given to infants. But can you tell which package below is the old version and the new?

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No? Old and new concentrations may be on the shelf at the same time, so you can’t trust packaging labeled as “new” to identify the new concentration. All manufacturers of single-ingredient liquid acetaminophen are now only making the lower concentration, but the rollout will take some time.

So what is a parent to do? The FDA has some advice:

#1 Read the Drug Facts label very carefully.

Parents and caregivers should always carefully read the Drug Facts label on the package to identify the concentration, dosage, and directions for use. Do not depend on banners identifying the package as a new product.

Look for the “active ingredient” section to identify the concentration. The stronger infant concentration comes in 80 mg/.8 mL or 80 mg/1 mL, while the less concentrated version comes in 160 mg/5 mL. The amounts may seem confusing, but the latter has fewer milligrams of acetaminophen per milliliter of liquid than the stronger concentration – thus less concentrated.

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#2 Use the correct dosing device.

The less concentrated version should also come with an oral syringe, while the more concentrated version may come with a dropper. Droppers measure a different volume than oral syringes, so using a dropper to measure the new concentration would result in the wrong amount being given to your child. It is important to use the device that comes with the product you are using. Never mix and match.

#3 Consult with your healthcare professional.

Even with the new concentration, there will be no dosage instructions for infants under 2. Do not rely on dosing information from old charts or sources on the Internet. Instead, you should consult with your pediatrician for dosing instructions. And be sure to confirm with your pediatrician the dose amount and the concentration to be used. If the dosing instructions provided by your pediatrician differ from what is on the label, confirm with them before administering.

If a pediatrician were to prescribe a 5 mL dose of the less concentrated version, but you give the more concentrated, your child could suffer a potentially fatal overdose during the course of therapy according to Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis.

For more information on acetaminophen and the new concentration, the FDA provides a number of resources in their safety alert here.

 

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2 Responses to “Acetaminophen Alert from the FDA”


  • I wish that manufacturers of acetaminophen and ibuprofen would just issue an old-fashioned recall when dosing instructions and concentrations change. Just allow parents to exchange the old stuff for the new.

    • Would have made things so much clearer wouldn’t it? Would be nice if all manufacturers went along together in this too.

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