FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen
[6/14/2024] Today, FDA issued a proposed administrative order, to address a safety issue related to over-the-counter (OTC) monograph drug products containing acetaminophen.
Based on a comprehensive scientific review of available data, FDA determined that acetaminophen continues to be associated with the risk of rare but serious skin reactions. This proposed order, if finalized, would require drug companies to add a warning to the labeling. The proposed warning below, which is the same as the warning language FDA previously recommended in a 2017 guidance, would alert consumers that the use of acetaminophen may cause severe 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.
FDA is seeking comments on this proposed order and instructions on how to submit comments are found below. After a review of comments, FDA will issue a final order. FDA has communicated about this safety issue in the past.
- In August 2013, FDA issued a Drug Safety Communication informing the public that use of acetaminophen is associated with a risk of rare but serious skin reactions.
- In 2017, FDA issued final Guidance for Industry titled, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reaction. The 2017 guidance recommended the addition of language in product labeling warning consumers that acetaminophen may cause severe skin reactions,
“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, M.D., director of the Office of Nonprescription Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s proposed order helps to ensure the safety and effectiveness of OTC drugs in our marketplace.”
Specifically, through Proposed Administrative Order (OTC000035): Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use, the agency proposes to amend the conditions described in OTC Monograph M0131 to require OTC oral analgesic, antipyretic, and antirheumatic (IAAA) drug products containing acetaminophen to include the above warning on the product labeling about serious skin reactions.
How to submit comments
Starting on August 8, submit comments on the proposed order (OTC000035) electronically in docket number FDA-2024-N-2422 in the Federal eRulemaking Portal until September 27, 2024. Please visit the Federal Register notice announcing the reopening of the comment period for this proposed order for more information
Additional information
- For answers to frequently asked questions about OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA portal.
- For a non-binding list of planned monograph activities that FDA intends to initiate over the ensuing 3 years, see the annual monograph forecast.
- For more information about acetaminophen, visit FDA’s consumer page and questions and answers page on the topic.
1 OTC Monograph M013 describes the conditions under which OTC IAAA drug products are generally recognized as safe and effective (GRASE). OTC monograph drug products may be marketed under the Federal Food, Drug, and Cosmetic Act without an approved drug application if they meet the conditions in the relevant OTC monograph(s) and other applicable requirements.