FDA approves first treatment for severe frostbite

Feb 14, 2024, 4:05 PM | Updated: Feb 15, 2024, 7:24 am

Severe frostbite happens when skin and underlying tissues freeze, limiting blood flow to the area. ...

Severe frostbite happens when skin and underlying tissues freeze, limiting blood flow to the area. (Yuliya Movchan, iStockphoto/Getty Images/File)

(Yuliya Movchan, iStockphoto/Getty Images/File)

(CNN) — The US Food and Drug Administration on Wednesday approved the first treatment for severe frostbite to reduce the risk of finger or toe amputation in adults.

Iloprost injection, marketed under the brand name Aurlumyn, is a vasodilator, a drug that opens blood vessels and prevents blood clotting.

“Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes,” Dr. Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

“It’s a game-changer, in my opinion,” said Dr. Peter Hackett, a professor of medicine at the University of Colorado Anschutz Medical Campus who specializes in high-altitude and wilderness medicine. “It’s a major step forward in frostbite treatment in the United States.”

Frostbite happens when skin and underlying tissues freeze, limiting blood flow to the area. Early symptoms include skin redness and pain, followed by numbness and white or grayish-yellow skin discoloration, according to the US Centers for Disease Control and Prevention.

The damage done by frostbite

Mild frostbite, also known as frostnip, does not cause permanent skin damage. However, severe frostbite can lead to permanent damage and require amputation, according to the FDA.

“Severe frostbite is not a very common problem in the US, but it’s a devastating problem for those that have the injury because severe frostbite almost always leads to amputations,” Hackett said.

There are not many effective treatments for severe frostbite. In recent years, physicians have tried other clot-busting drugs to save frostbitten fingers and toes, but these medications come with a high risk of bleeding and are effective only within 24 hours of the injury, Hackett said.

In contrast, he said, iloprost does not carry a risk of bleeding and can be used up to three days after the injury. He added that iloprost has been used to treat severe frostbite in other parts of the world – like Canada, Nepal and Europe – for years.

Iloprost was originally approved in 2004 in the US as an inhaled medication to treat pulmonary arterial hypertension, a type of high blood pressure in the lungs.

Its efficacy in treating severe frostbite was demonstrated in a small clinical trial that showed that no participants who had severe frostbite and received injections of iloprost alone needed an amputation after a week, compared with 19% of those receiving iloprost and other unapproved medications for frostbite and 60% of those receiving only other medications.

Common side effects of iloprost include headache, flushing, fast heart rate, nausea, vomiting, dizziness and low blood pressure resulting from the dilation of blood vessels, according to the FDA.

“Really, frostbite is an injury that needs to be prevented, not treated,” Hackett said.

People should have proper clothing, equipment and training before embarking on cold-weather outdoor activities, he said.

KSL 5 TV Live


FILE - A doctor uses a hand-held Doppler probe on a pregnant woman to measure the heartbeat of the ...

Amanda Seitz, Associated Press

Emergency rooms refused to treat pregnant women, leaving one to miscarry in a lobby restroom

Complaints about pregnant women being turned away from emergency rooms spiked in the months after states began enacting strict abortion laws following the 2022 U.S. Supreme Court decision overturning Roe v. Wade.

6 days ago

Marc Dunbabin, got his second chance at life with his family thanks to a bone marrow donor....

Emma Benson

Utah dad gets second chance at life thanks to bone marrow transplant

Utah dad hopes to meet the person who gave him second chance at life thanks to a bone marrow transplant.

7 days ago

Melatonin use can be especially dangerous in children and should only be used after consulting a pe...

Sandee LaMotte

Melatonin industry asked to voluntarily tighten standards after dramatic rise in childhood ER visits

A March 2024 report from the CDC discovered some 11,000 children had been seen in emergency rooms between 2019 and 2022 after ingesting melatonin while unsupervised.

8 days ago

Paris Hilton is pictured at a news conference....

Tran Nguyễn, Associated Press

Paris Hilton backs California bill to bring more transparency to youth treatment facilities

Hotel heiress and media personality Paris Hilton is backing California legislation that aims to bring more transparency to discipline used at facilities for troubled teens.

9 days ago

FILE: Getty Images...

Sylvia Hui, Associated Press

UK lawmakers will vote on a landmark bill to gradually phase out smoking

A plan by Britain’s government to introduce a landmark smoking ban that aims to stop young people from ever smoking is set to clear its first hurdle on Tuesday, despite vocal opposition from within Prime Minister Rishi Sunak’s Conservative Party.

9 days ago

(File photo)...

Jonel Aleccia AP Health Writer

Bird flu is spreading to more farm animals. Are milk and eggs safe?

A bird flu outbreak in U.S. dairy cows has grown to affect more than two dozen herds in eight states, just weeks after the nation's largest egg producer found the virus in its chickens.

12 days ago

Sponsored Articles

Women hold card for scanning key card to access Photocopier Security system concept...

Les Olson

Why Printer Security Should Be Top of Mind for Your Business

Connected printers have vulnerable endpoints that are an easy target for cyber thieves. Protect your business with these tips.

Modern chandelier hanging from a white slanted ceiling with windows in the backgruond...

Lighting Design

Light Up Your Home With These Top Lighting Trends for 2024

Check out the latest lighting design trends for 2024 and tips on how you can incorporate them into your home.

Technician woman fixing hardware of desktop computer. Close up....

PC Laptops

Tips for Hassle-Free Computer Repairs

Experiencing a glitch in your computer can be frustrating, but with these tips you can have your computer repaired without the stress.

Close up of finger on keyboard button with number 11 logo...

PC Laptops

7 Reasons Why You Should Upgrade Your Laptop to Windows 11

Explore the benefits of upgrading to Windows 11 for a smoother, more secure, and feature-packed computing experience.

Stylish room interior with beautiful Christmas tree and decorative fireplace...

Lighting Design

Create a Festive Home with Our Easy-to-Follow Holiday Prep Guide

Get ready for festive celebrations! Discover expert tips to prepare your home for the holidays, creating a warm and welcoming atmosphere for unforgettable moments.

Battery low message on mobile device screen. Internet and technology concept...

PC Laptops

9 Tips to Get More Power Out of Your Laptop Battery

Get more power out of your laptop battery and help it last longer by implementing some of these tips from our guide.

FDA approves first treatment for severe frostbite