FDA Proposes New Warning for Tylenol, Other Brands
FDA Proposes New Warning for Tylenol, Other Brands

By Zachary Stieber

U.S. drug regulators have proposed adding a new warning to Tylenol and other brands of acetaminophen, an analgesic that relieves pain.

If the proposal from the U.S. Food and Drug Administration (FDA) is finalized, companies that produce the medicines will be required to add a warning that states using acetaminophen may cause severe skin reactions.

A scientific review found that Tylenol and other acetaminophen brands, all available over-the-counter (OTC), can cause severe skin problems like Stevens-Johnson syndrome, according to the FDA’s proposed order.

Some 91 cases of the syndrome or toxic epidermal necrolysis, another rare but severe skin disorder, were reported to the FDA Adverse Event Reporting System from 1969 to 2012, the agency found. An additional 25 cases were reported between Feb. 25, 2012, and June 30, 2020.

Both Stevens-Johnson syndrome and toxic epidermal necrolysis are so severe that they frequently require hospital care and can, in certain causes, result in death.

Regulators also combed through the literature and found 21 cases of the syndrome, the necrolysis, or Acute Generalized Exanthematous Pustulosis reported across 18 articles, after excluding cases that lacked enough detail or featured additional products in addition to acetaminophen. Researchers determined six of the cases were probably related to acetaminophen, with the remaining 15 cases possibly related.

Less severe skin reactions such as rashes and blistering have also been recorded after use of acetaminophen.

To continue to be generally recognized as safe and effective, or include relevant information for consumers, FDA experts say the products “must include a warning about serious skin reactions.”

The warning, if finalized, would tell consumers that acetaminophen “may cause severe skin reactions” with symptoms including skin reddening, blisters, and rash.

“If a skin reaction occurs, stop use and seek medical help right away,” the proposed warning states.

The proposal “helps to ensure the safety and effectiveness of OTC drugs in our marketplace,” Dr. Theresa Michele, director of the FDA Center for Drug Evaluation and Research’s Office of Nonprescription Drugs, said in a statement.

The proposal follows a 2013 FDA alert that informed people acetaminophen was “associated with” serious skin reactions. The FDA in 2017 also issued guidance for manufacturers recommending they add warnings about the reaction. The new step would require the labels to be updated.

People desiring to comment on the proposed order can submit comments via an FDA portal through the end of July 29. All comments must include “OTC000035” and “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.”

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