Severe frostbite can now be treated with Actelion Pharmaceutical’s Aurlumyn, an injectable medication that dilates blood vessels. The medication is the first to receive U.S. Food and Drug Administration (FDA) approval for treating the medical condition caused by exposure to extreme cold. The main ingredient in Aurlumyn is iloprost, which opens blood vessels and prevents blood from clotting, reducing the risk of finger or toe amputation.
The drug was initially approved in 2004 to treat pulmonary arterial hypertension.
“This approval provides patients with the first-ever treatment option for severe frostbite,” said Dr. Norman Stockbridge, director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research, in a press release. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”
The FDA said the most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and low blood pressure.
Aurlumyn was studied in a 12-year trial that included 47 adults who presented with severe frostbite after being rescued from a mountain. The average age of the patients was 33; none had medical or surgical history. All cases of frostbite, affecting feet and hands, had occurred at a high altitude. Each patient took aspirin and received other standard care, like rapid rewarming. One group of study participants received Aurlumyn intravenously for six hours a day for up to eight days. The second group received Aurlumyn plus an unapproved medication, while the third group received other medications not yet approved for severe frostbite.
Using bone scans, researchers noted that zero patients in the Aurlumyn group needed amputation, compared with 19 percent of the patients in the second group and 60 percent in the third group.
How Does Frostbite Develop?
Frostbite can range from mild to severe. In its earliest stage, frostbite is actually known as frostnip. Frostnip does not damage the skin. Likewise, mild frostbite typically does not require medical intervention, as it does not cause permanent damage. Symptoms of frostbite include cold skin or a prickly feeling caused by reduced blood flow. Numbness follows, as well as inflamed or discolored skin. The skin may become stiff or waxy-looking as the frostbite worsens and severe frostbite sets in.
Severe frostbite occurs when the skin and underlying tissue freeze and blood flow stops. When this happens, amputation is sometimes the only available option. Now, Aurlumyn can be injected into the site to prevent blood from clotting.
While severe frostbite can be a risk in extreme sports like mountain climbing, it is also a risk to homeless populations, children, and older people. Whatever the person’s situation, being out in the cold for prolonged periods increases the risk of frostbite and can worsen the outcome of injuries.
In particular, individuals with certain medical conditions, including peripheral vascular disease, malnutrition, Raynaud’s disease, diabetes, hypothyroidism, arthritis, and stroke, are at higher risk of frostbite. Those living at high altitudes or where there is a high wind chill factor are also at heightened risk.
Bringing New Hope to Those in a Tough Situation
The medication’s approval provides an encouraging option for health care providers treating patients with severe frostbite. While additional studies will be required to better understand the long-term impacts and other potential uses of Aurlumyn, the Feb. 14 approval marks a significant milestone in the medical field.
The medication is expected to be available in Spring 2024. Pricing has not yet been set, NewsMax reported.