First drug approved for severe frostbite

For high alpinists and people in northern regions with extremely low temperatures in winter, frostbite poses a potentially major danger. For the first time, the US Food and Drug Administration (FDA) recently approved a drug called iloprost to treat such cases.

“This provides patients with the first treatment option for severe frostbite,” Norman Stockbridge, director of the Division of Cardiology and Nephrology (kidney diseases) at the U.S. Food and Drug Administration, said in a statement. “This new treatment option gives doctors a tool to prevent life-changing amputations of fingers or toes for those affected.”

Most superficial frostbites are harmless. But in severe cases – and these are feared by mountain climbers and residents of the northern regions of the world with temperatures of minus 20 degrees Celsius and even lower – this can even lead to amputations.

The new treatment option uses the active substance iloprost. It comes from the series of prostacyclin analogues and has a vasodilatory effect. The substance was previously approved mainly for the treatment of pulmonary hypertension. The FDA has expanded the indication to include severe frostbite.

The approval is based on a clinical study in 47 subjects with severe frostbite. The patients, randomly divided into three groups, received either iloprost alone as an infusion six hours a day for eight days, iloprost together with unapproved substances, or the latter alone (unapproved active ingredients).

After a week, it turned out that according to computed tomographic examination, no one in the first group was about to undergo an amputation, while in the second group 19 percent of the subjects and in the third group 60 percent. All patients had also received the platelet aggregation inhibitor ASA (acetylsalicylic acid; aspirin) via an infusion. ASD is intended to prevent thrombi from forming in the tissue affected by frostbite. (sda/apa)