WASHINGTON, June 15 (UPI) -- The U.S. Food and Drug Administration has approved Caldolor, the first injectable form of ibuprofen, to treat pain and fever in hospitals.
"Injectable ibuprofen and other non-steroidal anti-inflammatory drugs are promising pain management options," said Dr. Bob Rappaport, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Drug Products. "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."
Caldolor will be available for hospital use only.
The FDA said Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.
Caldolor is manufactured by Cumberland Pharmaceuticals Inc. of Nashville, Tenn.
