FRIDAY, Aug. 21 (HealthDay News) -- The U.S. Food and Drug Administration has issued warning letters to eight companies marketing over-the-counter topical products containing ibuprofen, noting that the drugs' claims have not been evaluated by the FDA, according to an Aug. 20 release issued by the agency.
The FDA notes that the drugs lack a new drug approval and therefore cannot be legally marketed. No over-the-counter drug monographs, or regulations that set requirements for labeling, formulations and indications, exist for topical ibuprofen, and it has no approved applications. Monographs do not exist even for oral ibuprofen, even though it is well accepted as a safe and effective treatment for pain and inflammation.
Topical ibuprofen has often been touted as being safer than oral ibuprofen, but these claims have not been evaluated by the FDA, and the warning letters advise the companies that they cannot continue to market their products without FDA approval. The affected products and their manufacturers are Emuprofen (Progressive Emu Inc.), BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories Inc.), Ibunex Topical Ibuprofen (Core Products International Inc.), LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products), IB-RELIEF (MEKT LLC), Profen HP (Ridge Medical Products), IbuPRO-10 Plus (Meditrend,Inc. dba Progena Professional Formulations), and IBU-RELIEF 12 (Wonder Laboratories).
"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," Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement.
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