WASHINGTON -- The FDA has issued warning letters to eight companies demanding that they stop marketing unapproved topical products containing ibuprofen as over-the-counter pain relievers.
Although some over-the-counter drugs can be lawfully marketed without prior FDA approval, they must meet applicable regulations for labeling, formulation, and indications set out in monographs.
Topical ibuprofen is not included in any over-the-counter drug monograph or approved for prescription use. Even orally administered ibuprofen -- which the FDA said is proven safe and effective for treating pain and inflammation -- has only been proposed but is not yet approved for an OTC monograph.
Products included in the warnings were:
The FDA issued the warning letters after reviewing claims made on labels or on company Web sites, such as "80% of Oral Medicines and Supplements are filtered out by the digestive system" on the Core Products' Ibunex page and "Studies show that as much as 95% of topically applied ibuprofen reaches site of the pain" on Ridge Medical Products' main page.
The agency said the companies are free to apply for drug approval and requested a response outlining how the companies will correct and prevent future violations.
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