In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill

FDA will work with manufacturers of OTCs containing acetaminophen to add warnings about serious but rare, skin reactions after analysis of adverse event reporting linked the painkiller to Stevens-Johnson Syndrome and toxic epidermal necrolysis. The agency said Aug. 1 a review of medical literature and the FDA Adverse Event Reporting System revealed 107 cases from 1969 to 2012 that identified the ingredient as a “probable” or “possible” of the skin conditions, including 67 hospitalizations and 12 deaths. The agency said the change “should be viewed within the context of the millions who, over generations, have benefitted from acetaminophen.” FDA also will require warnings about the skin reactions on prescription products containing acetaminophen. Other OTC non-steroidal anti-inflammatories already contain similar warnings.