As extremely cold temperatures persist across the region, Akron Children’s Burn Center is using a new frostbite treatment to reduce the risk of amputation.
Akron Children’s is one of only two hospitals in Ohio, along with the Ohio State University Wexner Medical Center, to use the IV medication called iloprost. It’s the first U.S. Food and Drug Administration-approved drug for treating severe frostbite in adults.
The brand formulation of the drug, Aurlumyn, was approved by the FDA in February 2024, but iloprost is already the standard of care in many European guidelines for treating severe frostbite, said Dr. Deepak Ozhathil, a burn surgeon at Akron Children’s.
“We’ve had salvage of digits that, in my clinical experience from the past, I would have expected the patient to lose,” Ozhathil said.
The hospital has used Aurlumyn on about a dozen patients since December, Akron Children’s spokeswoman Holly Pupino said.
To date, more than 30 U.S. institutions are using Aurlumyn, according to SERB Pharmaceuticals, which acquired the drug in October 2024. The number of hospitals stocking and including Aurlumyn in their protocols has been increasing every month.
Why it’s a game changer
Typically, a clot-busting drug is used to treat severe frostbite. The problem is, it only works within 24 hours of the patient getting frostbitten.
Iloprost can be used within 72 hours, and it can be used alongside a clot buster within 24 hours.
“That’s a game changer,” Ozhathil said. “A lot of these patients may not come in within 24 hours, or even two days. Some of them are in denial that they have a problem, or they have limited access to care, so they may not be able to get to a hospital within that time.”
Iloprost also has fewer side effects and a lower risk for bleeding, Ozhathil said.
SERB Pharmaceuticals said in an email that Ayrlumyn also has no labeled contraindications or known drug interactions.
The drug is administered intravenously over five days, with each infusion lasting about six hours, Ozhathil said. After five days, patients transition to blood thinners and aspirin.
The most common adverse events include headache, flushing, palpitations or tachycardia, nausea, vomiting, dizziness and low blood pressure, according to SERB Pharmaceuticals.
How it works
When a patient has severe frostbite, tiny blood vessels get clogged with platelets and blood clots. When this happens over a large number of small blood vessels, the tissue becomes deprived of oxygen and nutrition, Ozhathil said.
Iloprost works to open the blood vessels and reduce how much the platelets stick together. Better flow through the blood vessels can result in saving the tissue, Ozhathil said.
In a study measuring amputation rates in patients who used iloprost versus those who did not, zero patients who received the medicine needed amputation. Sixty percent of those who did not receive the medication needed an amputation.
Aurlumyn costs $5,500 per vial without insurance. Multiple vials may be needed for a full treatment course.
Avoiding frostbite amid housing insecurity
Ozhathil said as of Wednesday, Jan. 28, he treated four or five frostbite cases within the past week at Akron Children’s. He expects to see more patients as the cold spell continues.
“We’ve already had more patients this season than we had all of last year’s winter season,” he said.
Around 90% or more of patients who come in with frostbite have housing insecurity or concurrent psychiatric illness or drug abuse. So far this season, he said he has taken care of at least two dozen people with housing insecurity.
David Andress, 67, has had to figure out how to stay warm and avoid frostbite this winter.
Andress was forced to move out of his Akron home in January 2025 after a foreclosure. He then lived in an apartment complex for about eight months but was evicted in August after he stopped paying rent because of a major bedbug infestation.
Andress goes to Akron’s Emergency Overnight Warming Center at night and tries to go to the library or stay at Haven of Rest during the day.
The overnight shelter opens at 7 p.m., but he said a line starts to form about a half hour before.
“A place in line amongst 80 or 90 people is really important,” he said. “You’re going to get in, and getting in first is really kind of nice.”
Andress said buses have started to show up so people can stay warm while they wait, but before that, it was an “animal fest” with lots of people in distress because of the cold.
He said gloves don’t help if his hands are already cold – they just hold in the cold. He’s found that if he takes his gloves off and puts his hands under his armpits, his fingers stay warm.
“I’ve got good clothing,” he said. “When we get inside here, we’ve got hot coffee and hot chocolate and everything you need to get back warm again.”
How to recognize frostbite
Ozhathil said recognizing frostbite when it starts and going to the hospital right away are important. There are different degrees of severity, with each showing different symptoms:
- In the beginning, people will have frostnip, which is when the tissue reddens, and the skin becomes irritated. There may also be cold feelings, numbness and tingling sensations.
- When it becomes more severe, the top layer of the skin may blister or slough off, particularly when the tissue starts to rewarm. Joints may begin to stiffen up, and people experience a lot of pain, along with possible blisters and red tissue.
- True frostbite happens when the tissue dies, and muscles and joints may become affected as well. Large blisters form after rewarming; there may be shooting pain, and the skin itself becomes dead.
- Digits need to be amputated when they are purple or black and rubbery in texture. Joints may also stop working.
To avoid frostnip and frostbite, Ozhathil recommended reducing the amount of time exposed to severe cold, wearing multiple layers of clothes and not abusing drugs or alcohol outside in the cold.
Lauren Cohen is a community reporting intern for the Akron Beacon Journal and Signal Akron. The position is funded through a grant from the Knight Foundation, which is a financial sponsor of Signal Akron.