First-Ever Severe Frostbite Drug Approved

Frozen hands holding a mug | Image by ArtShotPhoto/Shutterstock

A new drug showing considerable promise in restoring tissue damaged due to cold exposure was approved by federal regulators last week.

The U.S. Food and Drug Administration (FDA) gave the green light to the first-ever drug aimed at treating severe frostbite. Trials of the injectable medication Aurlumyn, whose active ingredient is iloprost, showed considerable efficacy in opening blood vessels and preventing blood from clotting in frost-bitten tissue.

“Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes,” said Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, according to a news release.

Severe frostbite occurs when the skin and underlying tissues freeze due to exposure to cold, windy weather. Preceded by milder stages of frostnip and superficial frostbite, severe frostbite affects the deep tissue and even sometimes the bone, making it hard for joints and muscles to function. Symptoms may include the skin turning white or gray, a loss of sensation or pain in the affected areas, and the formation of large blisters a day or two later.

When tissue dies, it turns black and hard, and blood flow stops, requiring amputation.

In a bid for better outcomes, Eicos Sciences Inc. developed Aurlumyn and conducted an eight-day trial with 47 adults affected by severe frostbite to test the results.

Three treatment groups were organized. One received aspirin and buflomedil, an unapproved drug for peripheral arterial disease. Another was administered aspirin and Aurlumyn. The last was given aspirin, Aurlumyn, and — on the first day only — a synthetic protein known to activate the breakdown of blood clots.

A bone scan was done on day seven to determine whether an amputation of the affective appendage was required. The results found that none of the patients in the group receiving Aurlumyn and aspirin required amputation compared to nine in the group not receiving Aurlumyn. Three members of the group receiving both Aurlumyn and the synthetic protein required amputation of the affected tissue.

In the latest bout of frigid cold temperatures that kicked off 2024, an estimated 95 people died. Cold-related injuries and even deaths tend to affect homeless populations the most. Dallas has significant issues with homelessness and vagrancy, leading most recently to City officials exploring the possibility of “sanctioned” homeless encampments, as reported in The Dallas Express.

Experts on the subject told The Dallas Express that the “one-stop-shop” model for homeless services provided by the non-profit Haven for Hope in San Antonio shows how a “low-barrier” shelter idea can be implemented successfully. The endeavor has been said to have reduced unsheltered homeless by 77% in the downtown San Antonio area.

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