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1st Frostbite Drug Approved by FDA After Clinical Trial

1st frostbite drug approved by FDA
After a successful trial, the FDA approved the 1st frostbite drug. Credit: Iuliu Narcis Ilina / Flickr / CC BY-NC-ND 2.0

The U.S. Food and Drug Administration (FDA) has given the green light for the first-ever drug to treat severe frostbite.

The new drug, called iloprost, works by making blood vessels wider and stopping blood from clotting in frostbitten people. After a successful test on a small group of patients, the FDA has given the thumbs-up for its use.

It’s going to be sold under the name Aurlumyn. This drug aims to help adults with severe frostbite, potentially avoiding the need to cut off fingers or toes.

1 in 100,000 people had frostbite between 2016 and 2018

Severe frostbite happens when parts of the body, like the nose, ears, fingers, and toes, get frozen because of really cold temperatures (below 32 degrees Fahrenheit or 0 degrees Celsius).

When this freezing occurs, it stops blood from flowing well to those body parts, which means they don’t get enough oxygen and eventually die. Blood clots can also form, making the situation worse. Sometimes, the only solution is to remove the affected body part through amputation.

In the U.S., severe frostbite isn’t very common — about 1 in 100,000 people had a serious frostbite injury between 2016 and 2018. But when it does happen, it can have long-lasting effects on a person’s life.

“This approval provides patients with the first-ever treatment option for severe frostbite,” stated Dr. Norman Stockbridge, who leads the Division of Cardiology and Nephrology at the FDA’s Center for Drug Evaluation and Research, in the announcement on February 14.

“Having this new option provides physicians with a tool that will help prevent the life changing amputation of one’s frostbitten fingers or toes,” he said.

Early signs of frostbite

The Centers for Disease Control and Prevention (CDC) explains that an early sign of frostbite is when the skin loses feeling and changes color, often becoming white, grayish-yellow, or feeling unusually firm or waxy.

This is known as frostnip, the mildest form of frostbite, which usually only causes temporary skin damage. Frostnip might make the affected area feel like pins and needles or throbbing.

To treat frostnip, the skin should be gradually warmed indoors or soaked in warm water at temperatures between 105 to 110 degrees Fahrenheit (40 to 43 degrees Celsius), according to Mayo Clinic.

In previous cases, doctors have attempted to save frostbitten toes and fingers using other drugs that reduce clotting.

However, these treatments carry a significant risk of bleeding or are only effective if administered within 24 hours of the injury, as explained by Dr. Peter Hackett, a professor of medicine at the University of Colorado Anschutz Medical Campus, who was not part of the trial.

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