FDA warns companies using ibuprofen in OTC topical pain relievers
ROCKVILLE, Md. The Food and Drug Administration on Thursday announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter topical drug products containing the pain reliever ibuprofen.
The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed, the agency stated.
“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,” stated Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.
Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. However, ibuprofen is not included in any OTC drug monograph.
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, 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.
The names of the products and manufacturers that received warning letters are:
- Emuprofen (Progressive Emu);
- BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories);
- Ibunex Topical Ibuprofen (Core Products International);
- LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products);
- IB-RELIEF (MEKT);?Profen HP (Ridge Medical Products);
- IbuPRO-10 Plus (Meditrend, doing business as Progena Professional Formulations); and
- IBU-RELIEF 12 (Wonder Laboratories).
The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.