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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.