The U.S. Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite.
Known as Aurlumyn , the injected medication lowers the risk of finger or toe amputation in cases of profound“This approval provides patients with the first-ever treatment option for severe frostbite,” Dr. Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
Frostbite can range from mild cases that don't require medical intervention and don't cause permanent skin damage to severe cases where both the skin and underlying tissue are frozen and blood flow is stopped. In those instances, amputation is sometimes required, the FDA said. The FDA approval hinged on the results of a trial that randomized 47 adults with severe frostbite, all of whom receivedGroup 1 received iloprost intravenously for six hours a day for up to eight days.
None of the 16 patients receiving iloprost alone was found to need amputation, compared to 19% of patients in Group 2 and 60% of patients in Group 3.
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