The USFDA has recently approved iloprost injection, a vasodilator, for treating adults with severe frostbite to reduce the risk of finger or toe amputation. Iloprost was initially approved in 2004 for treating pulmonary arterial hypertension . It is the first FDA-approved treatment for severe frostbite and has received “Priority Review” and “Orphan Drug” designations.
The approval was granted based on a clinical trial conducted on 47 adults with severe frostbite who received intravenous aspirin and standard care. Clinical Trial The patients were randomized into three groups to receive intravenous iloprost alone (six hours daily for upto eight days) or an unapproved frostbite medication with or without iloprost. Based on the bone scan findings, no patients from the iloprost alone group required amputation, while 19% and 60% of patients from groups 2 and 3 required amputations,…
