Ibuprofen creams and rubs meant for topical application for pain relief could go off the shelves in US pharmacies very soon.
Eight ibuprofen cream makers in the US have been issued warning letters by the U.S. Food and Drug Administration for selling unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.
Ibuprofen is used in fever and to relive pain and inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.
Ibuprofen belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.
Creams and gels containing ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief currently being sold in the market are not approved by the USFDA.
Ibuprofen topical creams and solutions require an approved new drug application in order to be legally marketed.
Ibuprofen pills and liquid syrups, which are supposed to be consumed orally, have been approved as a safe and effective treatment for pain and inflammation.
However, no topical ibuprofen products are approved so far in US. 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 FDA, however, allows some OTC drugs to be marketed without first obtaining agency approval under its OTC drug monograph system. 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, stated in an official release.
The products and the companies 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) and IBU-Relief 12 (Wonder Laboratories)
US FDA asked the companies not to continue to market their products without approval. The FDA has requested 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.