FDA Approves Ibuprofen Injection to Treat Pain and Fever

The US Food and Drug Administration (FDA) yesterday approved an injectable formulation of ibuprofen (Caldolor, Cumberland Pharmaceuticals, Inc) for the treatment of pain and fever. The product will be available for hospital use only.

"Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options," commented Bob Rappaport, MD, in an agency news release. "But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products."

Dr. Rappaport is director of the Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA's Center for Drug Evaluation and Research.

Adjunctive use of ibuprofen injection may also reduce the need for opiate pain relief. In a clinical trial of 319 women who had undergone abdominal hysterectomy, patients receiving the product were less likely to require morphine on an as-needed basis.

When treating acute pain, the recommended dosing regimen for injectable ibuprofen is 400 to 800 mg administered for 30 minutes every 6 hours. To treat fever, a 400-mg dose should be followed by 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as needed.

Adverse events reported most commonly in clinical studies were nausea, flatulence, vomiting, and headache. Hypertension, serious dermatologic reactions, and severe allergic reactions may also occur.

As with other NSAIDs, ibuprofen injection should be used with caution in patients with congestive heart failure, those with kidney impairment, those at risk for blood clots, and patients with a prior history of ulcers or gastrointestinal bleeding. To reduce the risk for adverse events in these patients, the lowest effective dose should be administered for the shortest duration of time.