FDA orders halt of topical ibuprofen product sales

The U.S. Food and Drug Administration (FDA) has ordered eight companies to stop selling topical ibuprofen products because the salves have not been shown to be safe or effective.

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)

Ibuprofen is an anti-inflammatory drug that has been shown to be an effective treatment for pain and inflammation when taken by mouth.

But none of the companies marketing these topical ibuprofen drugs, which are applied to the skin, has demonstrated to the FDA, as is required by law, that the products are safe or effective, the FDA said.

“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.

FDA officials said that topical ibuprofen drugs are often promoted as being safer than oral ibuprofen, which can cause stomach ulcers, cardiovascular problems and other problems with long use.

However, none of these safety claims have submitted to the FDA for vetting, the agency said.

The FDA said it has sent letters to the marketers of the topical ibuprofen products ordering them to stop marketing the products.

The companies will have 15 days upon receipt of the letters to respond to the FDA in writing “stating how they will correct these violations and prevent similar violations in the future.”

To learn more:

• Read the FDA press release below.
• Visit the National Library of Medicine’s information page about ibuprofen.

FDA PRESS RELEASE

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

Tags: FDA, Topical Ibuprofen, Warning Letter

Category: Digestive System, Drugs & Medicines