• Posted February 15, 2024

FDA Approves First Treatment for Severe Frostbite

The U.S. Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite.

Known as Aurlumyn (iloprost), the injected medication lowers the risk of finger or toe amputation in cases of profound frostbite, the agency said.

“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 an agency news release. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one's frostbitten fingers or toes.” 

Frostbite can range from mild cases that don't require medical intervention and don't cause permanent skin damage to severe cases where both the skin and underlying tissue are frozen and blood flow is stopped. In those instances, amputation is sometimes required, the FDA said. 

Iloprost is a vasodilator, which opens up blood vessels and prevents blood from clotting. 

The FDA approval hinged on the results of a trial that randomized 47 adults with severe frostbite, all of whom received aspirin by IV and standard of care, into one of three treatment groups. 

Group 1 received iloprost intravenously for six hours a day for up to eight days. The two other groups received other medications that aren't approved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3). The main measure of efficacy was a bone scan taken seven days after the initial frostbite that predicted the need for amputation of at least one finger or toe.  

None of the 16 patients receiving iloprost alone was found to need amputation, compared to 19% of patients in Group 2 and 60% of patients in Group 3. 

Aurlumyn's most common side effects included headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness and hypotension (very low blood pressure). Aurlumyn also carries a warning noting that it may cause symptomatic low hypotension, the FDA noted. 

Iloprost was first approved in 2004 for the treatment of pulmonary arterial hypertension (high blood pressure).

More information

Visit the U.S. Centers for Disease Control and Prevention for more on hypothermia and frostbite.

SOURCE: U.S. Food and Drug Administration, news release, Feb. 14, 2024