US FDA Approves First Severe Frostbite Treatment To Reduce Risk of Amputation

On Wednesday, the US Food and Drug Administration approved the first severe frostbite treatment to reduce the risk of amputation of a finger or toe among adults.

First Severe Frostbite Treatment Approved

The treatment is iloprost injection, which is marketed under Aurlumyn. It is a vasodilator, a drug that opens blood vessels and stops blood clotting.

Dr. Normal Stockbrdige, the director of the Division of Cardiology and Nephrology at the Center for Drug Evaluation and Research of the FDA, shares that the availability of this new option offers physicians a tool that could aid in preventing amputation of frostbitten toes or fingers.

Dr. Peter Hackett, a medicine professor from the University of Colorado Anschutz Medical Campus, who specializes in wilderness and high-altitude medicine, also expresses that the treatment is a game-changer and is a massive step forward when it comes to the treatment of frostbite across the US. He notes that, while severe frostbite is not quite prevalent in the US, it can be devastating for those with the injury, as amputations result from nearly all cases of severe frostbite.

Severe frostbite does not have many effective treatments. In recent years, physicians have tried other drugs for clot-busting to save frostbitten toes and fingers. However, such treatments have a high bleeding risk and can only work within 24 hours of the condition.

In contrast, the iloprost injection does not pose a bleeding risk and can be used up to three days post-injury. Dr. Hackett adds that iloprost has been accepted as a severe frostbite treatment in other parts of the world, such as Europe and Canada.

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Iloprost Injection

The treatment gained approval in the US in 2004 as an inhaled medication for treating pulmonary arterial hypertension, a specific kind of high blood pressure within the lungs.

Regarding severe frostbite treatment, iloprost's efficacy was exhibited in a small clinical trial that revealed that no participants with severe frostbite and who got injected with the treatment required amputation after a week. This was compared to the 19% of those who received iloprost and other unapproved frostbite medications and the 60% of individuals who only received other medications.

Common iloprost side effects are flushing, headache, nausea, dizziness, vomiting, fast heart rate, and low blood pressure.

Frostbite

Frostbite happens when the skin is freezing because of exposure to freezing temperatures. Symptoms may include numbness, pain, swelling, skin discoloration, and blisters. It is more prevalent on the toes, fingers, ears, and nose.

In the case of frostbite, blood flow is limited in the area. Mild frostbite, called frostnip, may not lead to permanent damage to the skin. However, severe frostbite could result in permanent damage and may even require amputation.

Dr. Hackett also notes that frostbite is a condition that needs to be prevented and not treated. He adds that people should have proper equipment, training, and clothing before engaging in outdoor activities in cold weather.