Image by: Darien and Neil under CC BY-NC 2.0 DEED
The U.S. Food and Drug Administration has given the green light to Aurlumyn, a groundbreaking new treatment for severe frostbite that aims to minimize the risk of amputations. This marks the first time the FDA has approved a medication specifically for advanced stages of frostbite, offering a significant advancement in medical care for those at risk of losing fingers or toes due to extreme cold exposure.
Norman Stockbridge, M.D., Ph.D., from the FDA’s Center for Drug Evaluation and Research, hailed the approval as a milestone, providing a critical resource for physicians treating frostbite patients. The newly sanctioned injection, Aurlumyn (iloprost), is a vasodilator, a type of medication that dilates blood vessels to enhance blood flow and prevent clotting.
The effectiveness of Aurlumyn was demonstrated in a controlled trial involving 47 adults with severe frostbite. Results showed a stark contrast between those treated with iloprost and others receiving different, unapproved medications. Patients treated solely with iloprost exhibited a 0% prediction rate for amputation necessity based on a bone scan seven days post-frostbite, a significant improvement compared to groups not receiving iloprost.
Aurlumyn’s side effects include headaches, flushing, palpitations, increased heart rate, nausea, dizziness, and hypotension. The FDA has warned that the drug may induce symptomatic low blood pressure. Initially approved in 2004 for treating pulmonary arterial hypertension, Aurlumyn’s current approval was granted to Eicos Sciences Inc., underscoring the FDA’s ongoing commitment to public health and medical innovation.