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 ibuprofen, topical |
| Various ibuprofen trade names |
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Pharmaceutical
company:
Various topical ibuprofen manufacturers
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NEW WARNING
The Food and Drug Administration (FDA) informed health care professionals and consumers about its intent to take legal action against eight companies that illegally marketed OTC topical drug products containing ibuprofen. Products involved include Emuprofen, BioEntopic 15% Ibuprofen Crème, Ibunex Topical Ibuprofen, LoPain AF 15% Ibuprofen Crème, IB-RELIEF, Profen HP, IbuPRO-10 Plus, and IBU-RELIEF 12.
There are currently no approved indications for topical ibuprofen products. However, topical ibuprofen is commonly marketed as a "safer" alternative to oral ibuprofen because it isn't associated with adverse reactions that can result from prolonged use of oral ibuprofen, such as stomach ulcers and cardiovascular effects. However, the FDA points out that these safety claims for topical ibuprofen haven't been substantiated by the FDA, nor has the agency evaluated adverse effects that may be associated with these products.
The companies involved include:
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