FDA Warns Companies About Marketing Unapproved Topical Pain Relievers

The Food and Drug Administration today is warning companies about selling over-the-counter topical pain relief products containing ibuprofen, which have not been reviewed or approved by the agency.

Eight companies have been sent warning letters from the FDA informing them that their products require approval of a new drug application in order to be legally offered for sale in the United States. While the FDA allows some over-the-counter drugs to be sold without agency approval, that exemption does not apply to products containing the pain-killer ibuprofen, 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.

Ordered to Stop Selling

The FDA warning letters advise the companies to immediately stop marketing their products without agency approval. The companies have 15 business days after receiving the warning letter to tell the FDA how they will correct the violations and prevent similar violations in the future, officials said.

The FDA has not approved any topical ibuprofen products, billed by companies as safer alternatives for pain relief than oral ibuprofen, which can cause stomach ulcers, cardiovascular effects, and other side effects after prolonged use.

However, manufacturers’ claims that topical creams containing ibuprofen are safer than pills containing the drug have not be evaluated or reviewed by the FDA, officials said. Also, the agency has not determined the side effects of the topical ibuprofen treatments.

The following products and manufacturers have been sent FDA warning letters:

• 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)

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