FDA Approves Iloprost Injection For the Treatment of Adults With Severe Frostbite


Iloprost had also received Priority Review and Orphan Drug Designations for this indication, and FDA approval in 2004 for the treatment of pulmonary arterial hypertension.

The FDA has approved iloprost (Aurlumyn; Actelion Pharmaceuticals US) injection for the treatment of frostbite in adults. The injection reduces the risk of finger or toe amputation due to severe frostbite.

Frostbite, which occurs in several stages, can range from mild severity that does not require medical intervention or cause permanent skin damage, to severe frostbite. Severe stages occur when both the skin and underlying tissue are frozen and blood flow stops, and in some cases, can require amputation.

Women's frozen hands in the cold.Women's hands with dry skin and red fingers in the cold in winter.The concept of skin care in winter.

Image credit: Yuliya | stock.adobe.com

Iloprost is a vasodilator, which prevents blood from clotting. Previously, iloprost received both Priority Review and Orphan Drug Designations for the indication of severe frostbite in adults. It was originally approved in 2004 for the treatment of patients with pulmonary arterial hypertension.

The efficacy of iloprost in treating severe frostbite was primarily recognized in a controlled, open-label trial which enrolled 47 adults with severe frostbite. Participants were randomly assigned into 3 groups. Group 1 (n = 16) received iloprost intravenously 6 hours daily for up to 8 days, whereas groups 2 (n = 16) and 3 (n = 15) received other medications that are unapproved for the treatment of frostbite, either given with iloprost (group 2) or without iloprost (group 3). In addition, all patients, regardless of the group they were assigned to, received aspirin intravenously as well as standard of care.

The trial’s primary endpoint of efficacy was a bone scan which was obtained 7 days after patients’ initial frostbite and was used to predict the need for amputation of at least 1 finger or toe. On day 7, the bone scan finding predictive of needing amputation was not observed in patients who received iloprost alone; however, both groups 2 (n = 3; 19%) and 3 (n = 9; 60%) had scans that predicted the need for amputation. In addition, the presence of the bone scan abnormality was notably lower in the 2 groups the received iloprost.

Further, the majority of participants had follow-up information on whether or not they consequently underwent amputation for at least 1 finger or toe. The need for amputation was consistent with the bone scan findings.

The most common adverse events reported by patients who received treatment with iloprost were headache, flushing, heart palpitations and fast heartrate, nausea, vomiting, dizziness, and hypotension. In addition, iloprost

“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, in a press release. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”


US Food and Drug Administration. FDA Approves First Medication to Treat Severe Frostbite. News release. February 14, 2024. Accessed February 14, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-treat-severe-frostbite#:~:text=Today%2C%20the%20U.S.%20Food%20and,of%20finger%20or%20toe%20amputation.

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