Alerts
Ibuprofen topical OTC formulations marketed unlawfully - Warning letters issued by the FDA
August 26, 2009
Eight companies unlawfully marketing topical OTC ibuprofen products received FDA warning letters. The topical formulations, intended to provide pain relief, contain ibuprofen with other active ingredients. Topical formulations are promoted as having fewer side effects than oral ibuprofen, but these claims have not been evaluated by FDA. These products are unapproved drugs, requiring approved new drug applications prior to marketing.
The warning letters require the offending companies to cease marketing topical ibuprofen and respond in writing within 15 business days, describing how they will correct this violation and prevent future violations. The affected products are BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.), Emuprofen (Progressive Emu, Inc.), IB-RELIEF (MEKT LLC), Ibunex Topical Ibuprofen (Core Products International, Inc.) IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations), IBU-RELIEF 12 (Wonder Laboratories), LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products), and Profen HP (Ridge Medical Products).
Additional information is available at the following links:
- MedWatch Safety Alert
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179925.htm - Press Release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179689.htm - Warning Letters
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm
Updated
August 26, 2009; University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
