In Brief

FDA warns Sept. 13 that topical OTC analgesics in “rare cases” could seriously burn consumers, even during labeled use. “The majority of the more severe burns occurred with the use of menthol as the single active ingredient or menthol/methyl salicylate combination products,” with concentrations of more than 3% menthol and 10% methyl salicylate, an FDA spokeswoman said. She added a few cases involved products with capsaicin. FDA scientists uncovered the trend earlier this year during periodic safety surveillance of the adverse event reporting database and the medical literature, the spokeswoman said. The 43 adverse event reports uncovered revealed that most severe burns and blistering occurred after only one application and the reports did not suggest that consumers were using the products incorrectly. FDA does not currently require OTC topical muscle and joint pain relievers to warn that the products could cause serious burns, but “FDA is still assessing the cases and will make a determination on regulatory actions in the future,” the spokeswoman said. She said she could not speculate whether the agency would require warnings in the future or cap ingredient concentrations.

FDA takes another swipe at the pre-workout ingredient dimethylamylamine with an Aug. 28 warning letter to Regeneca Inc. warning that...