FDA Orders New Warnings on OTC Acetaminophen Drugs

A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions.

Background

The new guidance, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions, follows a 2013 warning by FDA that the drugs are associated with a risk of developing serious skin reactions.

Those reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), are known to be fatal and can occur after just a single use.

While FDA said it was difficult to determine the exact frequency with which the side effects occurred, regulators said that they believed the events occurred "rarely."

New Guidance

FDA's new draft recommendations are intended to warn consumers and healthcare providers about those risks, and apply to all single- and combination-ingredient acetaminophen-containing products marketed under the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products for Over-the-Counter Human Use, the agency said.

Under the new guidance, FDA "does not intend to object to the marketing of products containing the following warning language:"

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 language should be included in the "warnings" section of the product labeling, FDA said.

While the guidance is technically non-binding, FDA could object to the marketing of any product not containing the warning, preventing it from being sold.

Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (FR)