Home Medizin FDA genehmigt Iloprost für schwere Erfrierungen

FDA genehmigt Iloprost für schwere Erfrierungen

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved the Iloprost injection (Aurlumyn, Eicos Sciences Inc.) for the treatment of severe frostbite in adults to reduce the risk of finger or toe amputation.

The approval was based on a randomized, open-label study involving 47 adults (average age 33.1 years) with severe frostbite. Patients were randomly assigned to three treatment groups: Buflomedil, Iloprost, or Iloprost plus recombinant tissue plasminogen activator. All patients also received aspirin.

According to bone scans, the amputation risk was 0% and 19% with Iloprost alone and Iloprost plus recombinant tissue plasminogen activator, respectively, compared to a 60% risk with Buflomedil on day 7. Both differences were statistically significant.

The most common side effects of Iloprost are headaches, heat sensation, palpitations, rapid heartbeat, nausea, vomiting, dizziness, and hypotension. Iloprost contains a warning and precaution regarding the possibility of symptomatic hypotension.

This is the first approved treatment for severe frostbite. „With this new option, doctors have a tool that will help prevent the life-changing amputation of frozen fingers or toes,“ said Norman Stockbridge, MD, PhD, Director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

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