First-Ever Drug for Severe Frostbite Wins FDA Approval

Today, the U.S. Food and Drug Administration (FDA) announced a new injection treatment for severe frostbite. Approved for adults, Aurlumyn (iloprost) can reduce the risk of amputation following frostbite, officials say.

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”

Severe frostbite is the deepest stage of tissue damage from prolonged exposure to extreme cold. It’s characterized by loss of touch and temperature sensation. The tissue turns black before blistering badly.

While tissue regeneration from severe frostbite was previously possible with “optimal” medical treatment, according to the U.S. National Institutes of Health (NIH), injury reversibility was limited.

But the FDA’s case studies on iloprost, which opens blood vessels to prevent clots, were promising. The agency placed 47 adults with severe frostbite into three groups. “Group 1” received iloprost intravenously for six hours daily, for up to eight days. The two other groups received other treatments unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3).

No amputations needed

Bone scans followed, to predict the need for amputation. Zero out of 16 patients in Group 1 needed amputation. Group 2, the patients with iloprost along with the unapproved medications, fared better than Group 3.

Follow-up appointments proved consistent with the initial bone scan results, the FDA said.

The most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension (low blood pressure), according to the FDA.

Actelion Pharmaceuticals US, Inc. earned the approval. The Johnson & Johnson subsidiary specializes in treating pulmonary arterial hypertension (PAH), according to its website, and markets several drugs approved for that use.

Denis Urubko's frostbitten hand

Frostbite is common in high-altitude mountaineering. Denis Urubko frostbit his hand recently after a crevasse fall. Photo: Denis Urubko

Sam Anderson

Sam Anderson spent his 20s as an adventure rock climber, scampering throughout the western U.S., Mexico, and Thailand to scope out prime stone and great stories. Life on the road gradually transformed into a seat behind the keyboard, where he acted as a founding writer of the AllGear Digital Newsroom and earned 1,500+ bylines in four years on topics from pro rock climbing to slingshots and scientific breakthroughs.