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FDA announces approval for first severe frostbite treatment

The Food and Drug Administration says the new treatment's efficacy was established in an open-label, controlled trial.
FDA announces approval for first severe frostbite treatment
Posted at 7:58 PM, Feb 14, 2024

The U.S. Food and Drug Administration has announced what it says is the first-ever treatment for severe frostbite following an open-label, controlled trial.

Aurlumyn, or iloprost, is an injectable treatment used to treat severe frostbite in adults, which can reduce the risk of having a finger or toe amputated, the FDA said. 

In the trial, bone scans were analyzed seven days after showing severe frostbite symptoms — which was determined to be the time frame after which the need for amputation could be considered. Researchers said they observed a 0% need for amputation in 16 of the patients who received the treatment. 

The drug was first approved in 2004 to treat pulmonary arterial hypertension.

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The FDA's Dr. Norman Stockbridge said "Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one's frostbitten fingers or toes."

There are multiple stages of frostbite, including occurrences with mild symptoms that do not carry the need for medical treatment or cause permanent skin damage. Severe frostbite can cause skin and the underlying tissue to be damaged when it becomes frozen and the flow of blood stops.

The vasodilator drug Aurlumyn opens up blood vessels, stopping blood clots in frostbite incidents, the FDA said. 

47 adults with severe frostbite symptoms participated in the study. All participants received injected aspirin and standard care. The participants were divided into three groups, with one receiving injected iloprost (Aurlumyn) each day for 6 hours, lasting up to 8 days. 

The second group received iloprost along with other treatments not approved for frostbite, and the third group received only the unapproved frostbite treatments. 

Researchers found that the need for amputation was significantly less in the groups that received iloprost.

The FDA says the most common side effects from taking the drug include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension.

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