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 .
