BURST(NewsNation) — The Food and Drug Administration (FDA) has approved the first-ever treatment option for frostbite in adults.
The agency approved the Aurlumyn injection, which can help reduce the risk of finger or toe amputation, on Wednesday.
“Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes," said Dr. Norman Stockbridge, the director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.
The active ingredient in Aurlumyn is iloprost, a vasodilator that prevents blood from clotting, showcasing efficacy in treating frostbite patients, the FDA said. Its efficacy in treating severe frostbite was established in the controlled trial that occurred between 1996 and 2008, the agency said.
The approval was granted based on an open-label controlled trial involving 47 adults with severe frostbite. The trial found that patients treated with iloprost alone had a lower risk of amputation compared to receiving other treatments.
Before this, medical providers had no specific treatment to help reduce the risk of severe outcomes such as amputation. Alternatives have been proposed for treatment, ranging from low-molecular-weight heparin — often used as a blood thinner — to prostacyclin analogs, also used to inhibit blood clotting, the FDA said.
Like any medication, Aurlumyn has potential side effects, including headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness and hypotension, the FDA said.
Frostbite can occur in multiple stages. In a mild stage, it can be treated without medical intervention and permanent skin damage, according to the FDA. In several stages, both skin and underlying tissues are frozen and blood flow stops, the agency said. Amputation can occur if a patient reaches a severe stage.
Those with poor blood circulation are at a greater risk of developing frostbite, according to the CDC, as are those who don't dress properly for cold temperatures. Numbness, white or grayish-yellow skin, and skin that feels unusually firm or waxy could be signs of frostbite, the agency notes.