First drug for severe frostbite helps prevent amputation

Hands with frostbite

The US Food and Drug Administration (FDA) has approved Eicos Sciences’ Aurlumyn (iloprost) injection, the first FDA-approved medication to treat severe frostbite.

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, 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 lifechanging amputation of one’s frostbitten fingers or toes.”

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.

Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

Iloprost’s efficacy in treating severe frostbite was established in an open-label, controlled trial that randomised 47 adults with severe frostbite.

Group 1 received iloprost intravenously for six hours daily for up to eight days. The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3). The primary measure of efficacy was a bone scan obtained seven days after initial frostbite.

On day seven, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (three of 16) patients in Group 2 and 60% (nine of 15) patients in Group 3. The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost. The need for amputation was consistent with the bone scan findings.

Iloprost was originally approved in 2004 for the treatment of pulmonary arterial hypertension.

By DIANA SPENCER, Senior Digital Content Editor, DDW

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