FDA Proposes New Warning for Tylenol, Other Brands

Published on June 17, 2024

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....

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