FDA approves first treatment for severe frostbite

Severe frostbite happens when skin and underlying tissues freeze, limiting blood flow to the area. (Yuliya Movchan/iStockphoto/Getty Images/File)

The U.S. Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite to reduce the risk of finger or toe amputation in adults.

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Iloprost injection, marketed under the brand name Aurlumyn, is a vasodilator, a drug that opens blood vessels and prevents blood clotting.

“Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes,” Dr. Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

“It’s a game-changer, in my opinion,” said Dr. Peter Hackett, a professor of medicine at the University of Colorado Anschutz Medical Campus who specializes in high-altitude and wilderness medicine. “It’s a major step forward in frostbite treatment in the United States.”

Frostbite happens when skin and underlying tissues freeze, limiting blood flow to the area. Early symptoms include skin redness and pain, followed by numbness and white or grayish-yellow skin discoloration, according to the U.S. Centers for Disease Control and Prevention.

Mild frostbite, also known as frostnip, does not cause permanent skin damage. However, severe frostbite can lead to permanent damage and require amputation, according to the FDA.

“Severe frostbite is not a very common problem in the U.S., but it’s a devastating problem for those that have the injury because severe frostbite almost always leads to amputations,” Hackett said.

There are not many effective treatments for severe frostbite. In recent years, physicians have tried other clot-busting drugs to save frostbitten fingers and toes, but these medications come with a high risk of bleeding and are effective only within 24 hours of the injury, Hackett said.

In contrast, he said, iloprost does not carry a risk of bleeding and can be used up to three days after the injury. He added that iloprost has been used to treat severe frostbite in other parts of the world – like Canada, Nepal and Europe – for years.

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Iloprost was originally approved in 2004 in the U.S. as an inhaled medication to treat pulmonary arterial hypertension, a type of high blood pressure in the lungs.

Its efficacy in treating severe frostbite was demonstrated in a small clinical trial that showed that no participants who had severe frostbite and received injections of iloprost alone needed an amputation after a week, compared with 19 per cent of those receiving iloprost and other unapproved medications for frostbite and 60 per cent of those receiving only other medications.

Common side effects of iloprost include headache, flushing, fast heart rate, nausea, vomiting, dizziness and low blood pressure resulting from the dilation of blood vessels, according to the FDA.

“Really, frostbite is an injury that needs to be prevented, not treated,” Hackett said.

People should have proper clothing, equipment and training before embarking on cold-weather outdoor activities, he said.