FDA Makes Major Approval for Frostbite Treatment Drug

It should come as welcome news, especially in the winter.

Being outdoors in the winter means you might be safe from heat stroke, but there's a bevy of other potential risks to consider, especially if your skin is exposed. Frostbite can lead to serious injury and even possible amputation if left untreated. Luckily, if you find yourself in this situation, there's a drug that can help fix it. 

The Food and Drug Administration just issued approval for Aurlumyn, a first-of-its-kind drug meant to treat severe frostbite and reduce the need to amputate affected digits. The drug itself is an injection of iloprost, a medication used to treat ailments like pulmonary arterial hypertension, scleroderma, Raynaud syndrome, and other diseases where vessels are constricted and prevent blood flow to the tissues. 

Dr. Norman Stockbridge, director of the Division of Cardiology and Nephrology at the FDA's Center for Drug Evaluation and Research, celebrated the agency's move in a statement. "This approval provides patients with the first-ever treatment option for severe frostbite," he said. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes."

The approval comes after a trial of 47 adults dealing with severe frostbite. They were split into three groups and received differing treatments and observed for their reactions. One group received iloprost intravenously for six hours daily for up to eight days, while the other two received other drugs that are not approved for frostbite; one of these groups also received iloprost and the other didn't. 

Seven days after initial frostbite, the researchers examined the damage with bone scans, which are used to determine whether patients need fingers or toes amputated or not. They found that zero of the 16 patients who solely were given iloprost needed amputation. Three of 16 people who received iloprost in combination with an unapproved medication required amputation, while nine of 15 in the non-iloprost group needed amputation. 

While there may be good news for those with frostbite, prevention is probably the best medicine, so always ensure any exposed skin is covered up in cold weather.