The US Food and Drug Administration (FDA) has approved iloprost injection (Aurlumyn, Eicos Sciences Inc.) for the treatment of severe frostbite in adults to reduce the risk for finger or toe amputation.
The approval was based on a randomized, open-label trial of 47 adults (mean age, 33.1 years) with severe frostbite. The patients were randomly assigned to three treatment groups: buflomedil, iloprost, or iloprost plus recombinant tissue plasminogen activator. All the patients received aspirin.
The risk for amputation based on bone scans was 0% and 19% with iloprost alone and iloprost plus recombinant tissue plasminogen activator, respectively, compared with a 60% risk with buflomedil on day 7. Both differences were statistically significant.
The most common adverse events with iloprost are headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension. Iloprost carries a warning and precaution regarding the potential for symptomatic hypotension.
This is the first-ever treatment approved for severe frostbite. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes,” said Norman Stockbridge, MD, PhD, Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in a news release.
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