The FDA has warned eight companies about their marketing of unapproved over-the-counter topical agents containing the pain reliever ibuprofen drugs. The letters advise the companies that they may not continue to market their products without FDA approval.

Orally administered  generic  ibuprofen has been approved as safe and effective for pain and inflammation, but there are no approved applications for topical ibuprofen. The topical form is often promoted as a safer alternative to oral ibuprofen drags.

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An intravenous (IV) formulation of ibuprofen (Caldolor), designed primarily for use in hospitals, is now available. Caldolor drug is the first injectable product available in the U.S. for the treatment of pain and fever.

The introduction of IV ibuprofen drug should help achieve improved pain control with less need for opioid analgesics and fewer opioid-related side effects. Until now, the only injectable drugs available to relieve pain were opioids, which can cause sedation, nausea, vomiting, cognitive impairment, and respiratory depression.

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