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FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products
The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) 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. 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. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
“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.
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, Inc.)BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)Ibunex Topical Ibuprofen (Core Products International, Inc.)LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)IB-RELIEF (MEKT LLC)Profen HP (Ridge Medical Products)IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)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.
The warning letters are available on FDA’s Web site at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm
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3 comments:
Are there some specific side effects that have occurred with the use of Ibunex? Is the substance dangerous if I continue to use it? It has been the most effective pain reliever I have ever used so I hate to give it up while I still have plenty of it. Please let me know of any reported cases of side effects.
Thank you,
Betty
There are no side effects that I have heard of. The pharmaceutical companies would rather have the pain relief market all to themselves. The ibunex and gluconex products were a very good and safe option in my experience. AND they were easily available at an affordable price.
Ibunex is an extremely effective source of pain relief for osteoarthritis, as long as it is applied to joints close to the skin surface, i.e., fingers, toes, shoulder. It does not penetrate deeply.
I was startled to see that it was recalled by the same FDA which first approved ibuprofen as a prescription, and then as an OTC drug.
There are no side effects in my case. It smells a bit, but is worth it.
I can only believe that the recall is political in nature. Is some big Pharma company planning to put out an equivalent product? After all, ibprofen was considered safe enought to put out on the counter!!
A tip: there are other ibuprofen based formulas in other parts of the world...
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