Yes, spring is near, but temperatures are still falling in many areas and many people are still engaging in winter sports like skiing. So, it’s good to know that the US Food and Drug Administration (FDA) recently approved iloprost (Aurlumyn) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

The drug was approved based on a study that showed after seven days of treatment, a bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone compared to 19% (3 of 16) patients given an unapproved medication for frostbite plus iloprost and 60% (9 of 15) patients who received unapproved medications alone.

The bone scan abnormality predictive of amputation was significantly lower in the two groups receiving iloprost.

The most common side effects were headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension (blood pressure that is too low).

To read the full FDA announcement, click here,

For consumer-friendly background on the drug approval, click here

To learn more about preventing frostbite and hypothermia from the US Centers for Disease Control and Prevention, click here