FDA to Step Up Enforcement on Unapproved Ear Drops for Treatment of Ear Infections

The Food and Drug Administration on July 2 announced its intent to step up enforcement on unapproved ear drops labeled for treatment of ear infections and inflammation (here). The agency says unapproved and misbranded single-ingredient otic drug products containing benzocaine; fixed-dose combination otic drug products containing benzocaine and antipyrine; fixed-dose combination otic drug products containing benzocaine, antipyrine, and zinc acetate; fixed-dose combination otic drug products containing benzocaine, chloroxylenol, and hydrocortisone; fixed-dose combination otic drug products containing chloroxylenol and fixed-dose combination otic drug products containing chloroxylenol, pramoxine, and hydrocortisone are being marketed without evidence of safety or effectiveness, and have resulted in several cases of allergic reactions. FDA “intends to take enforcement action against such products and those who manufacture them or cause them to be manufactured or shipped in interstate commerce,” it said.