FDA Reopens Comment Period for Order Regarding OTC Monograph Drugs Containing Acetaminophen

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FDA has reopened the comment period for a June 14, 2024 Proposed Administrative Order concerning over-the-counter (OTC) monograph drugs that contain acetaminophen. The order (No. OTC000035), “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use,” would, if approved, eventually require the addition of a warning label to such OTC products, alerting consumers that the use of acetaminophen can cause severe skin reactions (1).

Comments will be accepted beginning Aug. 8, 2024, continuing through Sept. 27, 2024.

“Today’s actions represent important milestones in FDA’s implementation of new authorities provided by Congress as part of OTC Monograph Reform,” said Theresa Michele, MD, director of the Office of Nonprescription Drugs in FDA’s Center for Drug Evaluation and Research (CDER), in a press release (2). “Today’s proposed order helps to ensure the safety and effectiveness of OTC drugs in our marketplace.”

FDA determined the risk of acetaminophen skin reaction to be “rare but serious” based on what the agency said was a “comprehensive scientific review of available data” (2). The warning language to be used would be the same, which follows below, as recommended in a 2017 final Guidance for Industry entitled Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.

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 (2,3).

The link between acetaminophen and skin reactions, at least as far as FDA is concerned, dates back to 2013, when a Drug Safety Communication identified the reactions as indicative of Stevens-Johnson Syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis, all of which the agency said can be fatal (4). In addition to the risk factors listed above, FDA said at the time the reactions could also include “detachment of the upper surface of the skin.”

Those who develop a skin rash or reaction after using acetaminophen or another pain reliever or fever reducer are advised to discontinue use of the drug immediately, and to seek medical attention (4). Healthcare professionals are also instructed to assess these risks when evaluating patients, even though acetaminophen is commonly available as an OTC drug that does not require a prescription.

FDA directed interested parties to the Federal Register notice announcing the reopening of the comment period for more information, and said that due to technical difficulties, comments cannot be submitted in the OTC Monographs@FDA portal. Instead, these must be sent using docket number FDA-2024-N-2422 in the portal available at Regulations.gov (1).

References

1. FDA, Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (OTC Monographs@FDA, August 2024).
2. FDA. FDA Issues Agency-Initiated Proposed Order Regarding OTC Monograph Drugs Containing Acetaminophen. Press Release. Aug. 7, 2024.
3. FDA, Guidance for Industry, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (CDER, January 2017).
4. FDA, Drug Safety Communication: FDA Warns of Rare But Serious Skin Reactions with the Pain Reliever/Fever Reducer Acetaminophen (August 2013, updated February 2016).