(WASHINGTON) — The U.S. Food and Drug Administration approved the first medication to treat severe frostbite on Wednesday.
Aurlumyn, manufactured by Actelion Pharmaceuticals US, Inc., is an injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.
“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 a release. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”
Frostbite is an injury that occurs when the skin and the underlying tissues are damaged by cold temperatures. Treatment typically involves placing the skin in warm water or placing blankets over affected skin area.
Frostbite typically occurs in three stages, with the final stage being severe frostbite, which results in numbness and skin that turns hard and black due to skin cells dying. Large blisters will appear on the skin a day or two after cold exposure and skin may be permanently damaged, according to the Cleveland Clinic.
If underlying tissues are frozen and blood flow has stopped, the frostbitten extremity may need to be amputated.
Iloprost is the active ingredient in Aurlumy and is a vasodilator, a type of drug that dilates vessels so blood can flow easily and prevents clotting. It was originally approved in 2004 for the treatment of pulmonary arterial hypertension.
In a controlled trial, researchers examined 47 adults with severe frostbite, all of whom received aspirin by vein and standard of care. They were separated into three groups.
The first group received the drug intravenously for six hours daily for up to six days. The two remaining groups received medications that are unapproved for frostbite. The second group was given those medications with iloprost and the third group without it.
The patients received bone scans seven days after their initial frostbite to predict the need for amputation of at least one finger or toe.
On the seventh day, none of the patients in the first group receiving iloprost alone had bone scans that indicated potentially needing an amputation compared to 19% of patients in group two and 60% of patients in group three.
Additionally, abnormalities in the bone scan were significantly lower in the groups receiving iloprost alone or the iloprost combination.
“Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation,” the FDA release said. “The need for amputation was consistent with the bone scan findings.”
During the trial, the most common side effects of Aurlumyn included flushing, headache, nausea, vomiting, dizziness, heart palpations, increased heart rate and low blood pressure.
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