Severe Frostbite Gets a Treatment That May Prevent Amputation

The first time Dr. Peter Hackett saw a frozen patient, the man died from his injuries. He was in Chicago in 1971, and the man had gotten drunk and passed out in the snow, his fingers so frozen that gangrene eventually set in.

Dr. Hackett later worked at Mount Everest Base Camp, Denali, Alaska, and now in Colorado, where he became an expert in treating cold weather injuries. The experience was often the same: there was not much to do about frostbite except warm the patient, give aspirin, amputate in severe cases, and, more often, wait and accept that six months later the patient’s body might “ “self-amputation” by naturally detaching a dead finger or toe.

His mentor in Anchorage used to say, “Frostbite in January, amputation in July,” recalled Dr. Hackett, a clinical professor at the Altitude Research Center at the University of Colorado Anschutz Medical Campus. “For centuries, there was nothing else to do.”

This month, The Food and Drug Administration approved the first therapy for the treatment of severe frostbite in the country. The medication, iloprost, is given intravenously for several hours a day for a little over a week. It works by opening blood vessels to improve circulation, limiting inflammation, and stopping the formation of platelet clumps that can stop circulation and kill tissue. Those most at risk are a person’s fingers, toes, ears, cheeks, and nose.

The approval of the treatment is both a scientific novelty and a money-making bonanza for the pharmaceutical industry. Experts say there is no good data on how many people suffer from frostbite severe enough to receive this therapy. But cases could be as few as several dozen people a year in the United States, according to Dr. Norman Stockbridge, chief of the FDA’s division of cardiology and nephrology in the agency’s Center for Drug Evaluation and Research. who approved the medication.

“When you look at people who get frostbite a lot and are at risk of losing their fingers, it’s pretty rare,” Dr. Stockbridge said. Still, “it’s better to have medicine for this than nothing.”

In fact, the approval of the frostbite drug highlights an unspoken reality of the severe form of the injury: It is rare.

Those most at risk are high-altitude climbers, people who work outdoors without proper equipment, and homeless people, especially those with poor circulation. Freezing occurs in “extremely cold temperatures” according to the Centers for Disease Control and Prevention, Injuries often occur during the thawing process when vessels are damaged by clots and inflammation, strangling blood flow.

About two-thirds of overall cases of frostbite are milder, sometimes known as frostbite, and are not likely candidates for this drug, according to Allison Widlitz, vice president of medical affairs at Eicos Sciences, a startup in San Mateo, California. which received FDA approval to sell the drug. She estimated that the U.S. market for iloprost would be fewer than 1,000 people a year.

“Although it is a small market, it is an important new option,” he said. Eicos, which has seven employees, has not yet set a price for the drug, Widlitz said.

Many infusion therapies for such rare diseases are very expensive. Treatment with iloprost would involve intravenous administration for six hours a day and up to eight days.

Ms. Widlitz added that the company was formed to explore iloprost and medications for other unmet medical needs.

This is not the first use of the drug. The FDA first approved an inhaled version of iloprost in 2004 to treat pulmonary hypertension. Over the past decade, the intravenous version has been approved for severe frostbite in many European countries after a French doctor, Dr. Emmanuel Cauchy, demonstrated its effectiveness in treating frozen mountaineers.

Last year, a article in the International Journal of Circumpolar Health, a publication dedicated to health issues affecting people living in the Arctic Circle, found similar results in subsequent research. He noted that the use of iloprost “demonstrated a decrease in amputation rates relative to untreated patients.”

As an example, a 2018 article, published in Environmental and wildlife medicine, examined iloprost treatment in five Himalayan climbers and found that the drug prevented tissue loss in two of them and limited it in two others. Those case studies found that the drug was effective when administered between 48 and 72 hours after the onset of the injury, an important aspect because climbers often cannot receive immediate treatment.

In cases where frostbite is detected more immediately, a stroke medication called tissue plasminogen activator, or tPA, may be used to limit clot formation and reduce the risk of amputation. However, that medication, if not administered within hours, can cause serious complications and death. Unlike iloprost, tPA is not FDA-approved for severe frostbite, but doctors have turned to it off-label.

Dr. Hackett said the universe of people who suffer severe frostbite includes “mountain climbers, stranded snowmobilers, mushers, military personnel” and other people who work in frigid conditions, along with those who are homeless and “people with serious of drugs and alcohol that are exposed to the cold for long periods.”

That’s how Jennifer Livovich, a homeless Boulder, Colorado, resident, suffered severe frostbite one extremely cold night in December 2016.

She remembered that she had been drinking a lot and that the weather the day before was good: “Then I woke up the next day, covered in snow, and my shoe had fallen off while I was sleeping (maybe I kicked it off) and my foot left was glued to the ground.”

“I kept walking and I noticed my foot felt different, but I thought I was cold,” she said. Five days later, she ended up in a detox unit, where, while she warmed and thawed her foot, she “felt excruciating pain.”

The thawing stage is when damage begins to appear and capillaries deteriorate, sometimes beyond repair. “Different parts of my foot went from black to light blue,” she said.

Under a doctor’s care, she tried warm baths and elevated her foot, placing gauze between her toes so the rejuvenating skin cells wouldn’t fuse. Pieces of her skin fell off and she lost all her toenails. When the doctors were finally satisfied that the foot had healed as well as possible, “they shaved (that’s what they call it, ‘shaved’) a quarter of an inch off my big toe,” she said.

The shave occurred in the summer, roughly coinciding with the six-month timeline of Dr. Hackett’s mentor saying: injury in early winter and amputation in summer.

However small the market for the new drug may be, Dr. Hackett hopes it can save a few digits.

“It’s fabulous,” he said. “I might change the old saying.”

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