The U.S. Food and Drug Administration is urging parents and caregivers to carefully check the label on liquid acetaminophen sold for infants and children as a new product with a less concentrated form of this pain reliever hits the store shelves. The FDA warns that there is a danger for dosing errors based on the older, stronger concentrations of liquid acetaminophen.
Why the Change?
Until recently, infant liquid acetaminophen, found in such over-the-counter products as Little Fevers, Triaminic, Tylenol, and PediaCare, was only available in the more concentrated 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 having two different concentrations of liquid acetaminophen for infants and children was confusing and led to unintentional overdoses that made infants seriously ill and, in some cases, resulted in death from liver failure.
To avoid these dosing errors, many (but not all) manufacturers responded to the report by voluntarily changing the liquid acetaminophen marketed for infants to a single concentration of 160 mg/5 mL. This less concentrated version now has new dosing directions and may have a new dosing device — an oral syringe instead of a dropper.
Less Concentration…More Confusion
Because the change in concentration is voluntary, the older concentrations of liquid acetaminophen are still in medicine cabinets and in circulation on store shelves. The FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations are confused.
Carol Holquist, director of the FDA’s Division of Medical Error Prevention and Analysis, explains: “If a pediatrician prescribes a 5 mL dose of the less concentrated liquid acetaminophen, but the parents administer a 5 mL dose of the more concentrated liquid acetaminophen, the child can receive a potentially fatal dose over the course of therapy. Conversely, if a physician prescribes a dose based on the more concentrated liquid acetaminophen and the less concentrated medicine is used, the child might not receive enough to medication to fight a fever.”
Adding to the dosing confusion is the fact that the packaging and medicine bottles for the new concentration may look much the same as the old. (Trips to several pharmacies confirm this to be the case.)
What You Should Do
The FDA urges consumers to read the Drug Facts label to differentiate between liquid acetaminophen products and take these precautions:
– Look for the “active ingredient” section of the Drug Facts label usually printed on the back of OTC packaging. If the packaging says 160 mg/5mL or 160 mg (in each 5mL), then it is the less concentrated liquid acetaminophen and should come with an oral syringe for dose measurement. If the packaging says 80 mg/1mL or 80mg/0.8.mL, then it is the more concentrated version and should come with a dropper.
– Only use the dosing device that comes with the purchased product to ensure you are giving your child the correct dose. Droppers measure different volumes of medicine than do oral syringes.
– Packaging marketed for younger children will typically state “Infant Acetaminophen for Children 2-3 years,” while medicine marketed for older children will generally say “Children’s Acetaminophen Ages 2-11.” Always check the Drug Facts label to be sure you are buying the appropriate product based on your child’s height and weight.
– Be wary of package banners or labels that state the product is “new.” Some medicines with the old concentrations have this headline on their packaging as well.
– Consult your doctor before giving the medicine to your child to make sure you are both talking about the same concentration. This is especially important if your doctor’s dosing instructions are different from the instructions on the label.
The FDA stresses that there is no dosing amount specified for children younger than 2 years. If you have an infant or child under 2 years of age, always consult your doctor for dosing instructions.