The US Food and Drug Administration (FDA) is urging consumers to double check the label on liquid acetaminophen products marketed to infants and children before giving it to them. The popular pain reliever is marketed under various brands, including Tylenol, PediaCare, Triaminic and Little Fevers. There are also store versions and generic brands.

Giving children 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,” said the FDA in a Consumer Update released just before Christmas.

The FDA say there is a possibility that consumers will get confused and give children the wrong dose because a new, less concentrated form of the popular pain reliever is hitting the shelves in the US.

Until now, liquid acetaminophen for infants has only been available in the stronger concentration that does not require giving infants as much liquid in each dose.

With the arrival of the new, less concentrated version, it is possible to see how confusion, and wrong dosing may arise. For instance, parents and care givers may buy the newer less concentrated form, follow the dose for that, then when it runs out, buy the more concentrated one and give the incorrect dose, thinking it is the same strength as the previous one.

The less concentrated versions have come in because the more concentrated ones have been blamed for past overdoses. The FDA says some manufacturers will soon only be offering the less concentrated version for all children.

Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis, urges parents and care givers to “be very careful when you’re giving your infant acetaminophen”.

The FDA wants consumers buying acetaminophen products for infants and children to:

  • Read the Drug Facts package label “very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use”.
  • Don’t take any notice of banners that proclaim a product is “new”. Some medicines with the old (stronger) concentration could also be carrying this marketing headline.
  • To make sure you get the dosage correct, use only the dosing device that comes with the product when you buy it.
  • Talk to your pediatrician before you give the drug to your child: and double check you are both talking about the same concentration.

The FDA’s Center for Drug Evaluation and Research (CDER) reported in April 2011 that confusion over the different concentrations of liquid acetaminophen for infants and children was behind a series of overdoses that made babies and children seriously ill. Some of them died of liver failure as a result.

This is why some manufacturers have voluntarily changed to a less concentrated liquid acetaminophen marketed for infants. This has new dosing directions and may come with a new dosing device, such as a an oral syringe.

The older, more concentrated versions of liquid acetaminophen for infants come in a concentration of 80 mg per 0.8 mL or 80 mg per 1 mL.

The new version for infants has the same concentration as liquid acetaminophen for children: 160 mg per 5 mL.

In the Consumer Update, the FDA gives an example of how an overdose could occur:

If a doctor says the child should receive a 5 mL dose of the less concentrated version, but the parent inadvertently gives them a 5 mL dose of the more concentrated one, the child could potentially receive a fatal overdose during the course of treatment.

And similarly, if the doctor prescribes a dose based on the more concentrated version, and the parent gives the less concentrated one, the child might not get enough medication to fight a fever.

For more information, read the FDA’s Drug Safety Communication about how to avoid confusion and potential dosing errors with the different concentrations of liquid acetaminophen.

Written by Catharine Paddock PhD