Companies Marketing Unapproved Topical Drugs Containing Ibuprofen Receive FDA Warning

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry
Article Date: 21 Aug 2009 - 10:00 PDT

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The US Food and Drug Administration has written to eight companies marketing over-the-counter (OTC) topical drugs containing the pain reliever ibuprofen and other active ingredients to warn them that they are breaking the law because their drugs are unapproved.

In a press statement released on Thursday, the federal agency said the companies should have applied for approval before marketing their drugs.

The names of the companies and their associated products are:

• Progressive Emu, Inc: Emuprofen.
• BioCentric Laboratories, Inc: BioEntopic 15% Ibuprofen Crème.
• Core Products International, Inc: Ibunex Topical Ibuprofen.
• Geromatrix Health Products: LoPain AF 15% Ibuprofen Crème.
• MEKT LLC: IB-RELIEF.
• Ridge Medical Products: Profen HP.
• Meditrend, Inc. dba Progena Professional Formulations: IbuPRO-10 Plus.
• Wonder Laboratories: IBU-RELIEF 12.

The FDA has warned them that they may not continue to market their products without agency approval and has asked them to explain in writing within 15 days how they will address these violations and stop them happening again.

While the FDA allows some OTC drugs to be marketed without first obtaining agency approval, ibuprofen is not one of them because it is not included in any OTC drug monograph, that is the regulations that set out what is required in the drug's labelling, formulations and indications.

"Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application," said the FDA statement.

Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research (CDER) 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."

While 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, explained the FDA.

Also, while the agency has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed adding topical ibuprofen.

Topical ibuprofen products are often promoted it as a "safer" alternative to oral ibuprofen, which is described as having long term side effects such as stomach ulcers and cardiovascular problems. However, the FDA stated that:

"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."

Source: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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