top of page

[FDA News] FDA Approves First Medication to Treat Severe Frostbite

Date: 2/14/2024


Frostbite is a severe condition that can lead to amputation of the affected fingers or toes. However, there is now new hope for frostbite patients with the recent approval of Aurlumyn (iloprost) injection by the U.S. Food and Drug Administration (FDA).

A First-Ever Treatment Option

Aurlumyn is the first drug ever approved by the FDA to treat severe frostbite. It is a vasodilator, which means it opens up blood vessels and helps to prevent blood clots. This can help to improve blood flow to the affected area and reduce the risk of tissue damage and amputation.

Promising Clinical Trial Results

The approval of Aurlumyn was based on the results of a clinical trial that involved 47 adults with severe frostbite. The participants were divided into three groups, and one group received Aurlumyn in addition to standard care. The other two groups received either standard care alone or standard care with another medication that is not approved for frostbite.

The results of the trial showed that Aurlumyn was effective in reducing the risk of amputation. At the end of the study, none of the patients who received Aurlumyn had undergone amputation, compared to 19% of the patients in the standard care group and 60% of the patients in the other medication group.

Side Effects and Precautions

Aurlumyn is generally well-tolerated, but it can cause some side effects, such as headache, flushing, heart palpitations, nausea, vomiting, dizziness, and low blood pressure. It is also important to note that Aurlumyn can cause symptomatic hypotension, so patients should be monitored closely during treatment.

A New Era in Frostbite Treatment

The approval of Aurlumyn is a significant breakthrough in the treatment of frostbite. It offers new hope to patients who previously had no treatment options. With Aurlumyn, there is now a chance to prevent the devastating consequences of frostbite and preserve the function and appearance of the affected areas.

<This blog post is for informational purposes only and does not constitute medical advice. Please consult a healthcare professional for any questions or concerns you may have about frostbite or its treatment.>

Additional Resources:

provision consulting group

Provision work professionally while meeting clients' needs.

We will streamline the regulatory processes so that our clients can utilize their time

and money most efficiently.

Experience the best FDA approval directions and solutions!

 If you have questions about FDA regulation,


Office 1-909-493-3276


Post: Blog2_Post
bottom of page