FDA approves first-ever medication for severe frostbite to prevent amputation of toes and fingers

As much as one loves to enjoy a cozy winter, the season also brings considerable illnesses. It's not just the contagious diseases we need to watch out for, but also injuries we are prone to get because of the bitterly cold weather. One such common and age-old condition that impacts people during winter is frostbite. So far, severe cases of frostbite ended up in the affected parts of the hands or legs being amputated. But this month, the U.S. Food and Drug Administration (FDA) approved the first-ever effective medication to treat frostbite and this breakthrough reduces the risk of amputations.

As per the FDA's press release, the Aurlumyn injection enriched with the active ingredient, iloprost, has been proven to be the ultimate cure for frostbite. Norman Stockbridge, the director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, said in a statement, "This approval provides patients with the first-ever treatment option for severe frostbite." He added, "Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes." Now, impacts of severe frostbite in adults can be mitigated before it becomes too late and the need for amputation arises.

An extensive testing regime was executed, where 47 randomized test subjects who had severe frostbites were picked. The first group with 16 people was given iloprost for 6 hours per day for 8 consecutive days. The second group of 16 people received iloprost combined with other unapproved frostbite medications and the third group of 15 members received the unapproved medications without iloprost. To deduce the results of the medications, experts resorted to a bone scan that generally predicted if a frostbite patient requires amputation or not. 

So, on the 7th day, a bone scan for the 47 test subjects was done and the results were in favor of iloprost. In the first group that was treated solely with iloprost, people who required amputation were 0% which means the medication worked out on all of them. 19% of those in the second group, who had iloprost as part of their medication, needed amputation and the third group which wasn't exposed to iloprost at all showed 60% need for amputation. On follow-up observations, people who received iloprost showed consistent improvement and didn't need amputation.

Iloprost is a vasodilator commonly used to open blood vessels and prevent blood from clotting. So, originally the drug was a part of the treatment of pulmonary arterial hypertension and its usage was approved in 2004. But recently, its potential seemed to benefit frostbite treatment. Severe frostbite cases, where both the skin and underlying tissues freeze leading to a blockage in the blood flow, can be cured by preventing clotting and opening up the blood vessels aided by iloprost.

The press release also notified about the most common side effects of Aurlumyn and they include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness and hypotension (blood pressure that is too low). Also, experts warn about potential symptomatic hypotension on consumption of Aurlumyn. Warnings aside, the world now has access to a better solution for the common condition that previously threatened our skin in winter.