FDA Offers Guidance on OTC Acetaminophen

As part of its ongoing effort to reduce the risk of acetaminophen-related liver damage, the FDA has issued industry guidance for OTC pediatric oral liquid products containing acetaminophen.

As part of its ongoing effort to reduce the risk of acetaminophen-related liver damage, the FDA has issued industry guidance for OTC pediatric oral liquid products containing acetaminophen.

The document published in the Federal Register today provides recommendations for drug manufacturers, packagers, and labelers regarding acetaminophen concentration, container and carton labeling, and packaging for these products.

These recommendations are intended to encourage safer use by minimizing the potential for acetaminophen overdose due to medication errors or accidental ingestion, the FDA wrote.

These errors have been associated with serious adverse effects, including severe liver damage and death. Particularly, there have been reports of overdose attributed to confusion between concentrated acetaminophen drops (80 mg/0.8 mL and 80 mg/mL) and acetaminophen oral liquid (160 mg/5 mL).

The FDA guidance incorporates recommendations from a joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. These committees recommended moving to a single, standardized acetaminophen concentration for all OTC pediatric oral liquid drug products, given that the availability of different concentrations causes both confusion and error.

Pharmacy Times recently reported that acetaminophen is included on the Institute for Safe Medicine Practices’ list of highly error-prone medications.

The Consumer Healthcare Products Association previously announced it would voluntarily phase out all existing single-ingredient concentrated drop formulations of the product industry-wide, and then only market the 160 mg/5 mL concentration.

Shortly after, the FDA issued a Drug Safety Communication to inform consumers and health professionals of the 160 mg/5 mL concentration now marketed, advising caregivers to read the Drug Facts label on the product to correctly identify the concentration, dosage, and instructions for use.

Although the new FDA guidance is non-binding, it encourages safer use of both OTC and prescription acetaminophen-containing products in all patient populations.