The Food and Drug Administration (FDA) is renewing a warning about the potential for dosing errors with liquid products for infants. A new recommended strength may be one cause for the updated warning.
A new strength, 160 mg/5 ml, was introduced to actually help parents and caregivers give the correct dosage, but the change was voluntary for manufacturers. The goal was to have a single concentration of liquid acetaminophen available. Dosing errors were reported in several reviews and were attributed, in some circumstances, to the variety of strengths available.
The FDA announced that not all manufacturers have switched to the new strength and bottles with 80mg/mL plus 80mg/0.8mL are still on store counters. The old version and the new version also have similar packaging – adding to the confusion.
In a safety announcement issued late Thursday, the FDA posted pictures of new and old boxes of Little Fevers brand of infant acetaminophen. "Both boxes in this example say 'New' on the front, but only one of them contains the new concentration of liquid acetaminophen," the FDA said.
One difference you can use to tell the difference is that the older version comes with a dropper, and the newer version comes with a syringe intended to make dosing more precise.
The FDA stressed, again, parents need to use the dosing devise to make sure they are giving the correct amount of acetaminophen to their infant.
Patients and caregivers should contact their healthcare professional if they find the measuring device confusing or are unsure how to measure a dose for a child using the device provided," the agency said. Moreover, healthcare professionals should instruct adults in proper dosing of liquid acetaminophen products for infants when they recommend the drug.
The FDA website lists these suggestions for parents or caregivers that give their child acetaminophen.
“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.
If your pediatrician prescribes a 5 mL dose of the less concentrated liquid acetaminophen, but you administer a 5 mL dose of the more concentrated liquid acetaminophen, the child can receive a potentially fatal overdose during the course of therapy,
Conversely, if a physician prescribes a dose based on the more concentrated liquid acetaminophen and the less concentrated medication is used, the child might not receive enough medication to fight a fever, she say.
Acetaminophen is marketed for infants under brand names such as Little Fevers Infant Fever/Pain Reliever, Pedia Care Fever Reducer Pain Reliever and Triaminic Infants’ Syrup Fever Reducer Pain Reliever. There are also store brands on the shelves.
The ingredients indicators do look similar as you can see below.
Source : http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284563.htm