FDA Issues Draft Guidance on OTC Pediatric Liquid Products Containing Acetaminophen

Acetaminophen is a widely used pain reliever / fever reducer found in both prescription and over-the-counter drug products, both as a single ingredient or in combination with other medicines.  Although generally safe when used at the recommended dosage levels, its presence in so many products has led to an increased incidence of unintentional overdoses in consumers that were either not aware of its presence in the various products being simultaneously ingested, or of its potential for serious adverse events when too much is taken. Such overdoses can have serious consequences, most notably liver damage and even death.

To address this concern, the FDA has issued several regulations and guidance documents over the past 15 years, from warnings on labels regarding use of acetaminophen in consumers with a history of heavy alcohol use to, more recently, limiting the strength of the drug in a given dosage unit.

As part of this on-going effort to encourage safe use of acetaminophen products, the FDA announced (Federal Register, October 8, 2014) the availability of another draft guidance on the subject entitled “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen”.  In this document, the agency offers recommendations to industry to help minimize the risk to consumers of the liver damage associated with use of these products in children.  It is anticipated that these will eventually be codified into regulation following the formal notice and comment rulemaking process.

These recommendations include:

1.    Standardizing the concentration (to 160 mg per 5 mL) of acetaminophen in all single ingredient acetaminophen oral liquids marketed for pediatric use

2.    Changes to the labeling to enhance the display of this new concentration and more clearly indicate the age range and intended dosage for each 

3.    Revision of the packaging to include a dosage delivery device, preferably one with a flow restrictor, with clear markings that correlate to the dosing directions

It is noteworthy that some of these recommendations have already been adopted by much of the pharmaceutical industry voluntarily and this guidance should encourage others to follow.  

The FDA requests that any comments on this draft guidance document be received by December 8, 2014 to ensure consideration in any final version.