First Medication to Treat Severe Frostbite Approved by the FDA

On Wednesday, the U.S. Food and Drug Administration authorized the first drug to treat severe frostbite.

Eicos Sciences Inc. produces Aurlumyn, an injection used to treat adult severe frostbite and lower the risk of amputating a finger or toe.

According to a release from the FDA’s Center for Drug Evaluation and Research, Dr. Norman Stockbridge, director of the division of cardiology and nephrology, “this approval provides patients with the first-ever treatment option for severe frostbite.” “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”

When the skin and underlying tissues are harmed by low temperatures, it can result in frostbite. The usual course of treatment is to cover the injured skin region with blankets or submerge it in warm water.

Usually, there are three phases to frostbite; severe frostbite is the last stage, which causes numbness and hard, black skin from dying skin cells. The Cleveland Clinic states that large blisters may form on the skin a day or two after exposure to the cold and that skin damage may be irreversible.

An amputation may be necessary for the frostbitten extremity if the underlying tissues have frozen and the blood supply has stopped.

The main component of Aurlumy is iloprost, a vasodilator—a kind of medication that widens blood arteries to facilitate blood flow and inhibit clotting. In 2004, it was first authorized to treat pulmonary arterial hypertension.

Researchers looked at 47 adults with severe frostbite in a controlled experiment; aspirin was administered via vein along with conventional treatment. Three groups were formed out of these.

The medication was given intravenously to the first group for up to six days, six hours a day. The drugs given to the two surviving groups were not authorized for treating frostbite. These same drugs were administered with iloprost to the second group and not with it to the third.

Seven days following their first frostbite, the patients underwent bone scans to determine if they would require the amputation of at least one finger or toe.

In contrast to 19% of patients in group two and 60% of patients in group three, none of the patients in the first group receiving iloprost alone had bone scans on the seventh day that suggested they would require an amputation.

Additionally, the groups getting iloprost alone or in conjunction with other medication had considerably less anomalies in the bone scan.

“Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation,” the FDA release said. “The need for amputation was consistent with the bone scan findings.”

Aurlumyn’s most frequent side effects during the trial were flushing, headaches, nausea, vomiting, dizziness, palpitations in the chest, elevated heart rate, and low blood pressure.