Feb. 14 (UPI) — The Food and Drug Administration on Wednesday approved the first medication injection to treat severe frostbite.
Aurlumyn, which has the active ingredient iloprost, reduces the risk of finger or toe amputation, the FDA said.
“This approval provides patients with the first-ever treatment option for severe frostbite,” the FDA’s Dr. Norman Stockbridge said in a statement. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”
The FDA said the new medication is a vasodilator that opens blood vessels and prevents blood from clotting.
A random trial of 47 adults with severe frostbite who were given Aurlumyn injections had bone scans for determining abnormalities predicting the need for amputation.
“The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost,” the FDA statement said. “Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation. The need for amputation was consistent with the bone scan findings.”
Of 16 patients getting the Aurlumyn/iloprost shots alone, none were found to need amputation. That compared with 19% needing amputation in a second group and 60% of patients in a third trial group, according to the FDA.
The FDA said frostbite happens in several stages from mild — which doesn’t require medical intervention — to severe, in which tissue is actually frozen, halting blood flow and sometimes leading to amputation.
Side effects of the new frostbite treatment include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness and hypotension.
The iloprost active ingredient got previous FDA approval in 2004 for pulmonary arterial hypertension treatment.
