The US Food and Drug Administration has approved the first injectable medication to treat frostbite.
Actelion Pharmaceutical’s Aurlumyn uses main ingredient iloprost to dilate blood vessels and prevent 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. "Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes."
According to the Epoch Times, the most common side effects are headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and low blood pressure.
The medication was studied in a 12-year trial which included 47 adults who had severe frostbite following mountain rescues. The average age of the patients was 33, and each of them had frostbite affecting the feet and hands at high altitude.
Each patient took aspirin and received standard care, while one subgroup took an IV of Aurlumyn for six hours per day for up to eight days. The second group received Aurlumyn plus an unapproved medication, while a third group received other medications not yet approved for severe frostbite.
None of the patients who received Aurlumyn required amputation, vs. 19% in the 2nd group, and 60% in the third group.
As the Epoch Times reports further;
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.
The US Food and Drug Administration has approved the first injectable medication to treat frostbite.
Actelion Pharmaceutical’s Aurlumyn uses main ingredient iloprost to dilate blood vessels and prevent 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. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”
According to the Epoch Times, the most common side effects are headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and low blood pressure.
The medication was studied in a 12-year trial which included 47 adults who had severe frostbite following mountain rescues. The average age of the patients was 33, and each of them had frostbite affecting the feet and hands at high altitude.
Each patient took aspirin and received standard care, while one subgroup took an IV of Aurlumyn for six hours per day for up to eight days. The second group received Aurlumyn plus an unapproved medication, while a third group received other medications not yet approved for severe frostbite.
None of the patients who received Aurlumyn required amputation, vs. 19% in the 2nd group, and 60% in the third group.
As the Epoch Times reports further;
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.
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