The US Food and Drug Administration is encouraging parents and caregivers to carefully inspect the label for liquid acetaminophen for infants and children being sold as a new product with a less concentrated form of this pain reliever that has hit the shelves. The FDA warns that there is a risk of dosing errors based on the older, stronger concentrations of liquid acetaminophen.
Why the Change?
Until recently, the infant liquid acetaminophen found in such controversial over-the-counter products as Low Fever, Triaminic, Tylenol and PediaCare was only available in the narrower and therefore stronger 80 mg/1mL or 80mg/0.8 mL versions. An April 2011 report from the FDA’s Center for Drug Evaluation and Research found that two different concentrations of liquid acetaminophen for infants and children were confusing and led to ignorance of the dose that made children seriously ill and in some cases died from
To avoid these dosing errors, many (but not all) manufacturers responded to the report by voluntarily changing the liquid acetaminophen marketed to children to a single concentration of 160 mg/5 mL. This less compact version now has new dosing directions and can have a new dosing device – an oral syringe instead of a dropper.
Less Concentration…More Confusion
Because the change is intentional, the old concentrations of liquid acetaminophen are still in the drug store and in the circulation of safe stores. The FDA is concerned that children may be given too much or too little medicine if the different concentrations are confused.
Carol Holquist, director of the FDA’s Division of Medical Error Prevention and Analysis, explains: “If the pediatrician prescribes 5 mL of less concentrated liquid acetaminophen, and the parents administer a 5 mL dose of the more concentrated liquid acetaminophen, the child may receive a potentially fatal dose. Conversely, if the physician prescribes a more liquid dose acetaminophen should be used more carefully and less frequently, so that the child does not receive enough medicine to fight the fever.
Adding to the dosing confusion is the fact that packaging and medication bottles for new concentrations can look a lot like the old ones. (The routes to some pharmacies confirm that this is the case).
What to do
The FDA urged consumers to read the Drug Manufacturers’ label to distinguish between liquid acetaminophen products and take these precautions;
– Look for the “active ingredient” section Drug Manufacturer’s label on the back of the OTC packaging usually printed. If the package says 160 mg/5mL or 160 mg (in each 5mL), then liquid acetaminophen should be less concentrated and come with an oral syringe for measuring the dose. If the package says 80 mg/1mL or 80mg/0.8.mL, then it is a more concentrated version and should come with a dropper.
– Only use the dosing device that comes with the product to give your child the correct dose. Medicine drops measure different volumes than oral syringes.
– Packaging marketed for younger children typically say “Infant Acetaminophen for children 2-3 years”, while medicine marketed for older children will generally say “Children’s AcetaminophenAges 2-11.” Always check the product label to make sure you are buying the right product based on your child’s height and weight.
– Beware of package flags or labels that state the product is “new”. Some drugs with old concentrations have this in their features as well.
– Consult your doctor before you give the medicine to your child, make sure you tell both about the same intention. This is especially important if the instructions given by your doctor are different from the instructions on the label.
The FDA does not have a defined dosing amount for children younger than 2 years. If you have a baby or child under 2 years old, always consult your doctor for teaching instructions.
