Iloprost receives FDA approval for Treatment of Severe Frostbite

Iloprost, a synthetic prostacyclin analog used as vasodilator to treat pulmonary arterial hypertension (PAH), has been approved by the U.S. Food and Drug Administration for treatment of severe frostbite. This is first approved medication in the USA to treat severe frostbite in adults to reduce the risk of amputation.

Frostbite is a serious condition that require immediate medical attention. It is caused due to exposure to freezing temperature long enough to allow ice crystals to form in the tissues. People working outdoors in cold regions such as security personals, industrial workers, mountaineers or hikers etc are usually affected by frostbite. Amputation of fingers and toes because of frostbite is common in such regions despite advances in health care services.

Iloprost is a synthetic prostacyclin analog. It reverses vasoconstriction and inhibits platelet activation, acts as vasodilator, opens blood vessels and prevents blood clotting. It was first approved in 2004 for the treatment of pulmonary arterial hypertension (PAH).

Iloprost and thrombolytics are beneficial for treating frostbite. In Canada, patients with severe frostbite involving freezing of skin and underlying tissues and stoppage of blood flow have been successfully treated with iloprost. The old drug has now been approved by the U.S. Food and Drug Administration (FDA) for treatment of severe frostbite.

The FDA granted the approval to Eicos Sciences Inc. to manufacture iloprost for treatment of severe frostbite by the brandname “Aurlumyn”.

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References:

1. FDA Approves First Medication to Treat Severe Frostbite. Posted on 14 February 2024. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-treat-severe-frostbite/
2. Regli, I.B., Oberhammer, R., Zafren, K. et al. Frostbite treatment: a systematic review with meta-analyses. Scand J Trauma Resusc Emerg Med 31, 96 (2023). https://doi.org/10.1186/s13049-023-01160-3
3. Poole A. and Gauthier J. 2016. Treatment of severe frostbite with iloprost in northern Canada. CMAJ December 06, 2016 188 (17-18) 1255-1258; DOI: https://doi.org/10.1503/cmaj.151252
4. Gruber, E., Oberhammer, R., Brugger, H. et al. Prolonged critical avalanche burial for nearly 23 h with severe hypothermia and severe frostbite with good recovery: a case report. Scand J Trauma Resusc Emerg Med 32, 11 (2024). https://doi.org/10.1186/s13049-024-01184-3

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