FDA Approves First Severe Frostbite Medicine

The U.S. Food and Drug Administration (FDA) has approved the first ever medication to treat severe frostbite.

The FDA announced its approval of Aurlumyn, manufactured by Eicos Sciences Inc, on Wednesday — an injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

Frostbite occurs when skin and tissue are damaged by cold temperatures. It can lead to a loss of feeling and color in many different parts of the body, though it usually impacts extremities such as the nose, ears, cheeks, chin, fingers, and toes, according to the Centers for Disease Control and Prevention (CDC).

While mild cases can be treated by warming up the impacted area, the most severe cases of frostbite can permanently damage the body and lead to amputation if both the skin and underlying tissue are frozen and blood flow is stopped.

According to the American Burn Association, 1,300 people die in the United States due to cold exposure. Moreover, alcohol and drug use increases the chances of frostbite.

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., the director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in a news release. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”

Iloprost, which is the active medical ingredient in Aurlumyn, is a vasodilator, which is a drug that opens blood vessels and prevents blood from clotting. Originally, in 2004, it was approved by the FDA for the treatment of pulmonary arterial hypertension.

The drug’s ability to effectively treat frostbite was validated in an open-label, controlled trial in which 47 adults with severe frostbite were randomly separated into three treatment groups. They all received aspirin injections and the current standard of care for severe frostbite. The first group, however, received iloprost injections for six hours daily for up to eight days. The second group received other medications that are unapproved for frostbite along with iloprost, and the third group received the other medications but not iloprost.

Seven days after the initial frostbite, patients underwent a bone scan that determined whether they would need to have at least one finger or toe amputated. Zero out of 16 patients in the first group required amputation based on the bone scan, while three out of 16 patients in the second group needed at least one finger or toe amputated, as did nine out of 15 patients in the third group.

“The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost,” said the FDA in the release. “The need for amputation was consistent with the bone scan findings.”

The most common side effects of the drug include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension (blood pressure that is too low). The medication also contains a warning and a precaution noting that it may cause symptomatic hypotension.