(news nation) — The U.S. Food and Drug Administration (FDA) has approved the first-ever treatment option. frostbite For adults.
The agency has approved allumin injectionIt may help reduce the risk of finger or toe amputation.
“This new option provides physicians with a tool to help prevent life-changing amputations of frostbitten fingers and toes,” said Dr. said Dr. Norman Stockbridge. Pharmaceutical Evaluation Research Center.
The active ingredients of Allmin are: Iloprost, a vasodilator that prevents blood clotting, is effective in treating frostbite patients, the FDA said. Its effectiveness in treating severe frostbite was established in controlled trials conducted between 1996 and 2008, the agency said.
Approval was granted based on an open-label, controlled study in 47 adults with severe frostbite. The trial found that patients treated with iloprost alone had a lower risk of amputation compared to patients treated with other treatments.
Until now, health care providers have not had specific treatments to reduce the risk of severe outcomes such as amputation. Alternative drugs 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 other drugs, Allumin has potential side effects, including headaches, facial flushing, palpitations, increased heart rate, nausea, vomiting, dizziness and low blood pressure, the FDA said.
Frostbite can occur in multiple stages. Mild stages can be treated without the need for medical intervention or permanent skin damage, according to the FDA. At some stage, both the skin and the underlying tissue freeze, stopping blood flow, the agency said. If the patient reaches a severe stage, amputation may occur.
It has been reported that people with poor blood circulation are at higher risk of developing frostbite. CDC, as well as people who are not properly dressed due to the cold. Numbness, white or grayish-yellow skin, and unusually hard or waxy skin can be signs of frostbite, authorities say.
