FDA Approves First Drug for Frostbite Treatment

FDA Approves First Drug for Frostbite Treatment

The US Food and Drug Administration (FDA) has given its approval for a groundbreaking treatment for frostbite, which could significantly reduce the need for amputations. This treatment works by causing the blood vessels to dilate, thus preventing necrosis (tissue death) in the fingertips. The treatment is also available in Israel, and its Ministry of Health may soon approve it as well.

Frostbite is a condition that occurs when the skin and underlying tissues freeze due to exposure to cold temperatures, resulting in inadequate blood flow to the extremities. This can lead to the formation of necrosis, which may necessitate the amputation of the affected fingers. Early signs of frostbite include redness and pain in the skin, but these symptoms can rapidly progress to loss of sensation and a blue discoloration of the fingers. In Israel, several mountain climbers have already suffered from severe frostbite.

Until now, there have been no effective treatments for severe frostbite. Anticoagulants have been experimented with in recent years, but these are only effective if administered within 24 hours of the injury and carry a high risk of bleeding. The newly approved treatment, known as “Ilufrost”, is delivered via infusion over approximately 8 hours. If necessary, this infusion can be repeated over several days or even once a week for an extended period of time.

A clinical study has found that Ilufrost can successfully dilate constricted blood vessels and save the affected organ. However, the treatment does have side effects, including headaches, facial flushing, rapid heart rate, nausea, dizziness, and a drop in blood pressure. As a result, it is only administered under medical supervision in a hospital setting. Ilufrost is already used in Israel to treat Raynaud’s phenomenon, a condition characterized by the contraction of blood vessels in response to cold. Now, with the approval of the FDA, it can be used to treat frostbite as well.

Frostbite can lead to tissue stagnation and the development of necrosis. When the injury occurs rapidly, “ice crystals” form inside the damaged cells, leading to the destruction of the cell membranes. This triggers an inflammatory response, resulting in blockages in the blood vessels that supply oxygenated blood to the hand, ultimately leading to necrosis.

Like thermal burns, frostbite injuries can be classified into several degrees depending on the depth of the injury. First degree injuries are superficial, second degree injuries involve large, clear fluid-filled blisters surrounded by edema and redness, third degree injuries involve deep tissue damage and small, sometimes bleeding blisters, and fourth degree injuries affect the muscles and bones, resulting in necrosis.

Frostbite most commonly affects the ears, nose, cheeks, chin, fingers, and toes, as these body parts are often exposed to the cold. There have also been reports of frostbite occurring in the corneas of the eyes.

In 2014, Israeli travelers were caught in an avalanche in Anpurna, Nepal, with temperatures far below freezing. Most of the injured individuals suffered from frostbite, which without treatment can have life-threatening consequences. Field treatment for frostbite includes removing wet clothing and warming the affected area with warm (but not hot) water or the body heat of a rescuer. It is important not to rub the frostbitten area or expose it to a fire or heating element, as this can cause further tissue damage.

Upon arrival at the hospital, frostbite victims are given an anti-tetanus vaccine and a process of intensive warming begins. The affected area is immersed in water heated to 37 to 39 degrees Celsius, and the thawing process is completed in 15 to 30 minutes. Since frostbite can accelerate the process of blood vessel blockage in the affected area, victims are treated with thrombolytic drugs to break up blood clots. The drugs tPA or heparin are typically administered via infusion. These drugs are expensive and were reportedly not available at the medical center in Kathmandu.

The next step in the treatment process is rehabilitation, which involves elevating the affected limb and bandaging it with sterile cotton pads placed between the fingers. Bandages or pressure garments are removed from the area, and the warm bath treatments continue. Painkillers are also administered, and surgical consultations are conducted throughout the hospital stay. If necessary, necrotic tissue is removed, dressings are changed, and pain relief and warm water treatments are provided. Now, with the approval of Ilufrost, it will also be possible to start an infusion treatment within 3 days of the injury. This will allow the blood vessels in the injured area to dilate, hopefully allowing blood to flow to the end of the limb and facilitating the healing of the tissues, thus preventing amputation.