Health
FDA greenlights first drug for severe frostbite: ‘Very important approval’
Frostbite may have met its match.
The U.S. Food and Drug Administration (FDA) has approved the first medication to treat severe frostbite, the agency announced this week.
The drug, iloprost (brand name Aurlumyn) is intended to reduce the risk of finger and toe amputations due to dangerously cold extremities.
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Iloprost was originally approved for treatment of pulmonary arterial hypertension, a condition in which high blood pressure affects arteries in the lungs and heart.
“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in a press release.
Frostbite occurs when cold temperatures cause parts of the body to freeze, primarily the fingers, toes, nose, cheeks and chin. (iStock)
“Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”
Frostbite occurs when cold temperatures cause parts of the body to freeze, primarily the fingers, toes, nose, cheeks and chin, according to the U.S. Centers for Disease Control and Prevention (CDC).
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Initial symptoms include numbness, tingling or color changes, Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, told Fox News Digital.
“Severe frostbite can cause white or blue skin and, later, fluid-filled blisters,” said Siegel, who was not involved in the drug development.
Initial symptoms of frostbite include numbness, tingling or color changes. (iStock)
Prolonged frostbite can lead to permanent damage or amputation, the CDC stated.
Aurlumyn is intended for severe frostbite cases, in which both the skin and the underlying tissue are frozen, and blood flow is stopped.
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“Iloprost, the active ingredient in Aurlumyn, is a vasodilator, a drug that opens blood vessels and prevents blood from clotting,” the FDA release stated.
The FDA’s approval follows a randomized clinical trial that included 47 adults with severe frostbite, who were divided into three groups.
Prolonged frostbite can lead to permanent damage or amputation, the CDC stated. (IStock)
One group received iloprost intravenously for six hours daily for up to eight days.
Another group received other medications that are not approved for frostbite, combined with iloprost.
A third group received other medications without iloprost.
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Seven days after the initial frostbite, each participant received a bone scan to determine whether fingers or toes would need amputation.
The patients who received iloprost did not require any amputation, compared to 19% of patients who received iloprost with other medications and 60% of patients who only received other medications.
Signage is seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, on Aug. 29, 2020. (REUTERS/Andrew Kelly/File Photo)
“This is a very important approval,” Siegel told Fox News Digital.
“Severe frostbite causes blood clotting and can lead to amputation. This new drug’s active ingredient, ilopost, is a vasodilator that preserves blood flow to the area of severe frostbite and prevented the need for amputation in all cases in a small study.”
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Aurlumyn, which was developed by Eicos Sciences Inc. in Maryland, was found to cause some side effects, the FDA noted.
Those included heart palpitations, accelerated heart rate, nausea, headache, flushing, vomiting, dizziness and low blood pressure.
For that reason, Siegel noted, the drug can only be administered by a physician.
Fox News Digital reached out to Eicos Sciences Inc. and the FDA requesting additional comment.
For more Health articles, visit www.foxnews.com/health.
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Yoga is known to boost relaxation, strength and flexibility – and now a new study has found the practice could improve cancer survivors’ quality of life.
A randomized trial led by the University of Rochester Medical Center found that a four-week yoga program significantly reduced insomnia, fatigue, anxiety and mood disturbances after cancer treatment.
The findings were presented last week at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
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The study was conducted across multiple U.S. community cancer care sites, including 410 adult cancer survivors averaging 54 years of age. Around 75% were breast cancer survivors, and none of them had practiced yoga regularly within the prior three months.
A randomized trial led by the University of Rochester Medical Center found that a four-week yoga program significantly reduced insomnia, fatigue, anxiety and mood disturbances in cancer survivors. (iStock)
The participants were randomly assigned to two groups. Half of them received only standard survivorship care without the yoga, while the other half received standard care and were also enrolled in the Yoga for Cancer Survivors (YOCAS) program.
As part of the YOCAS program, the survivors completed two instructor-led 75-minute yoga sessions each week, including 18 Gentle Hatha yoga and Restorative yoga poses, breathing exercises and mindfulness training.
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Based on questionnaires completed by the patients, the survivors in the yoga group experienced “moderate-to-large” reductions in overall mood disturbance, “small-to-medium” reductions in anxiety and “medium-to-large” reductions in fatigue, the study found.
The improvements in mood and fatigue appeared to be linked to yoga’s beneficial effect on sleep quality, according to the researchers.
As part of the YOCAS program, the survivors completed two instructor-led 75-minute yoga sessions each week, including 18 Gentle Hatha yoga and Restorative yoga poses, breathing exercises and mindfulness training. (iStock)
“This indicates that cancer survivors have an option to alleviate these cancer-related side effects at the same time, without adding another drug,” lead investigator Yuri Choi, PhD, of the Wilmot Cancer Institute, University of Rochester Medical Center, in Rochester, New York, told Fox News Digital.
The study did not reveal any major safety concerns or serious adverse events related to the yoga practice.
“This indicates that cancer survivors have an option to alleviate these cancer-related side effects at the same time, without adding another drug.”
The study did have some limitations, chiefly that the findings are preliminary and have not yet been peer-reviewed for a medical publication.
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“The sample in our clinical trial was relatively homogeneous, with most participants being women (96%), breast cancer patients (75%), Caucasian (93%), and having some college or higher education (82%),” noted Choi.
“We are adapting our intervention to reach all cancer patients and survivors, including the creation of a mobile app to reach people in rural communities.”
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The research also excluded patients with metastatic cancer (whose disease had spread to other parts of the body).
The total study was only four weeks, so more research is needed to determine long-term benefits.
If the findings are confirmed by peer-reviewed publications, this could lead to recommendations for structured yoga programs as a non-drug supportive therapy for cancer survivors, the researchers noted. (iStock)
If the findings are confirmed by peer-reviewed publications, this could lead to recommendations for structured yoga programs as a non-drug supportive therapy for cancer survivors, the researchers noted.
Some yoga studios may use different names for Gentle Hatha and Restorative yoga, such as Foundations Yoga or Healing Yoga, Choi noted.
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“Survivors should also look for certified yoga instructors who have experience working with cancer patients/survivors or individuals with other challenging health conditions,” the researcher advised. “They should not be afraid to ask their oncology team for referrals to qualified instructors in their community.”
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Choi also noted that the research did not reveal whether other types of yoga, such as heated-room or rigorous-flow yoga, are safe or beneficial for cancer survivors.
The study was funded by the National Cancer Institute.
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