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FDA endorses flow restrictors on pediatric liquid acetaminophen
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The FDA recently issued a draft guidance to the industry endorsing the use of flow restrictors for over-the-counter pediatric oral liquid drug products containing acetaminophen for children aged younger than 12 years.
“We are providing recommendations regarding acetaminophen concentration, container labels, carton labeling, and packaging of such products as well as for any associated delivery devices,” the FDA wrote in the draft guidance. “FDA’s recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.”
OTC pediatric oral liquid drug products containing acetaminophen have been linked to overdoses due to medication errors that resulted in serious adverse events, such as severe liver damage and death.
Most notably, the FDA reported a series of overdoses attributed to confusion between concentrated acetaminophen drops (80 mg/0.8 mL and 80 mg/mL) and acetaminophen oral liquid (160 mg/5 mL).
In addition to concerns associated with the multiple pediatric formulations of varying concentrations, the FDA issued this guidance to address reports of overdose attributed to:
- concomitant administration of two products containing acetaminophen;
- inconsistent and/or unclear units of measurement under directions on labeling; and
- dosage delivery devices that were either not packaged with the medication or poorly designed, making it difficult to dispense an exact dose.
“We recommend the adoption of container features designed to improve safety by potentially contributing to more accurate dosing and helping to reduce the incidence and magnitude of accidental acetaminophen ingestion by children, such as an appropriate flow restrictor contained in the opening of the immediate container,” the FDA noted. “If a flow restrictor is included, it should be attached to the container in a way that prevents it from being pushed into the bottle or easily removed.”