FDA warns of unapproved over-the-counter topical ibuprofen products

The FDA informed healthcare professionals and consumers that it has issued warning letters to eight companies marketing unlawful over-the-counter topical pain relief drug products containing ibuprofen. These products, which contain ibuprofen in combination with other active ingredients, are unapproved new drugs that require an approved New Drug Application (NDA) in order to be legally marketed. Topical ibuprofen is often promoted as a safer alternative to oral ibuprofen because of certain side effects (eg, stomach ulcers, cardiovascular effects) associated with prolonged oral ibuprofen use.  However, there are no approved applications for topical ibuprofen products and the safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.  

The following products and manufacturers have received warning letters:

  • Emuprofen (from Progressive Emu)
  • BioEntopic 15% Ibuprofen Crème (from BioCentric Laboratories
  • Ibunex Topical Ibuprofen (from Core Products International 
  • LoPain AF 15% Ibuprofen Crème (from Geromatrix Health Products) 
  • IB-RELIEF (from MEKT) 
  • Profen HP (from Ridge Medical Products) 
  • IbuPRO-10 Plus (from Meditrend dba Progena Professional Formulations) 
  • IBU-RELIEF 12 (from Wonder Laboratories)

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179925.htm.