ISMP cautions about new acetaminophen labeling for infants

December 1, 2011

Liquid acetaminophen for infants is being shipped to hospitals and drug stores in new concentrations, even though manufacturers may not be providing notice about the concentration change, according to the Institute for Safe Medication Practices.

Liquid acetaminophen for infants is being shipped to hospitals and drug stores in new concentrations, even though manufacturers may not be providing notice about the concentration change, according to the Institute for Safe Medication Practices (ISMP).

Last year, manufacturers announced a voluntary reformulation of the former 80 mg/0.8 mL infant drops to the current 160 mg/5 mL strength for children under the age of 12. The goal behind the new strength is to make it easier for parents and caregivers to avoid dosing errors by using a single strength of liquid acetaminophen, according to ISMP.

However, pharmacists may still have the older 80 mg/0.8 mL concentration in stock. “We are worried that the new concentration may be inadvertently intermingled with the old concentration, especially since the products can look quite similar. The different concentrations may also be difficult to see on the label,” wrote ISMP President Michael Cohen, RPh, in a recent ISMP newsletter.

Alarmingly, at least 4 infants’ acetaminophen products on pharmacy shelves did not have the new strength listed on the front panel of the carton, according to ISMP. As a result, pharmacists should either exhaust all supplies of the older product before circulating the new concentration, or be sure that all remaining older product is removed from storage locations throughout facilities before distribution of the newer product begins, as recommended by the ISMP.

Overdoses of acetaminophen – which can cause liver failure – are among the most frequent, unintentional poisonings seen in emergency departments.

For more information, visit www.ismp.org or www.otcsafety.org.