FDA Approves Treatment For Severe Frostbite
Date
2/25/2024 7:15:16 PM
(MENAFN- The Peninsula) Washington Post
The Food and Drug Administration this month approved the first-ever medication to treat severe frostbite in adults, a move that could reduce the risk of amputations from exposure.
The injectable drug is made by Eicos Sciences and will be marketed as Aurlumyn. Its active ingredient, iloprost, is a vasodilator, meaning it opens the blood vessels and prevents clotting. Iloprost was first approved in 2004 to treat pulmonary arterial hypertension.
Severe frostbite occurs when skin and underlying tissue are exposed to freezing temperatures, causing blood vessels to narrow and limiting blood flow. Eventually, the slowed circulation and reduced heat cause ice crystals to grow inside the tissue.
Frostbite usually affects the extremities, such as fingers and toes, but it can also occur on the nose, ears and other parts of the body. People with health issues such as vascular disease and diabetes are at particular risk, as are those without housing or adequate clothing, or people who work outdoors for prolonged periods during the winter.
The most severe cases of frostbite require amputation of the affected limbs or digits. A 2021 study found that at least 20 percent of frostbite-injured patients become disabled from amputations and that such injuries disproportionately affect the homeless population.
In a randomized clinical trial of 47 patients with severe frostbite, none of the 16 patients who received only the new drug had to have amputations, compared with three patients who received other medications along with iloprost, and nine people who didnot receive iloprost.
"Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one's frostbitten fingers or toes,” Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA's Center for Drug Evaluation and Research, said in a news release.
An Eicos spokeswoman said Aurlumyn will become available this spring and that the price for the drug had not yet been determined.
MENAFN25022024000063011010ID1107897568
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.