The FDA Warns Illegal Marketers Of Topical Ibuprofen
The Food and Drug Administration (“FDA”) has issued warning letters to 8 companies who are illegally marketing over-the-counter ("OTC") products that contain topical ibuprofen. The FDA warning letter states: “Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph.”
Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, FDA officials warn that "these 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."
"These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so," said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. Companies that received warning letters may not continue to market their products without FDA approval, and have been identified by the FDA as:
Progressive Emu, Inc. (Emuprofen)
BioCentric Laboratories, Inc. (BioEntopic 15% Ibuprofen Créme)
Core Products International, Inc. (Ibunex topical ibuprofen)
Geromatrix Health Products (LoPain AF 15% Ibuprofen Créme)
MEKT LLC (IB-Relief)
Ridge Medical Products (Profen HP)
Meditrend, Inc. d/b/a Progena Professional Formulations (IbuPRO-10 Plus)
Wonder Laboratories (IBU-Relief 12)
If you have purchased topical ibuprofen, or have been injured as a result of using topical ibuprofen, please contact us to discuss your legal options.