FDA Recommends New Label Warning on OTC Acetaminophen Products

On November 28, 2014, the FDA issued a draft guidance for industry recommending that an additional warning statement be included on the labeling of single- and combination-ingredient acetaminophen products informing users of the possibility of severe skin reactions. 

This new guidance is specifically directed to those companies marketing acetaminophen products under the Tentative Final Monograph for Internal Analgesic, Antipyretic and Antirheumatic Drug Products and follows an earlier Drug Safety Communication (DSC) issued by the FDA in August 2013.  At that time, following a review of its Adverse Event Reporting System database, as well as medical literature, the FDA determined that there was a potential for rare but serious skin reactions associated with the use of these products.  The DSC was issued to notify both healthcare professionals and patients of this risk and advised anyone who may have experienced a skin rash or similar reaction to stop taking the drug and seek medical attention.   The DSC also mandated the addition of a warning statement to labels of prescription drugs containing acetaminophen and requested the same for over-the-counter acetaminophen-containing products marketed under an approved application.  It appears that most of these manufacturers have incorporated the label changes.
 
For OTC acetaminophen products marked under the aforementioned tentative final monograph, the FDA is now encouraging these manufacturers to do likewise and has indicated that it will not object to the following language on the labeling: 

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening  blisters  rash
If a skin reaction occurs, stop use and seek medical help right away.

The new warning should be placed directly under the Liver Warning and should appear on all package configurations.  The guidance document does not address alternative wording that could potentially misbrand the product.

The FDA requests that comments on this draft guidance document be received by January 27, 2015 to ensure consideration in any final version.