FDA OKs Emergency Use of Freeze-Dried Plasma for the Military

Marcia Frellick

Disclosures

July 10, 2018

The US Food and Drug Administration (FDA) has granted emergency use of a freeze-dried plasma product to help treat military members in the battlefield.

The emergency use authorization allows the military to use pathogen-reduced leukocyte-depleted freeze-dried plasma, referred to as French FDP, while the agency works toward formal approval of the product.

"Earlier this year, we reaffirmed our commitment to the (US) Department of Defense (DoD) and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members," FDA Commissioner Scott Gottlieb, MD, said in a press release. "This is especially true when it comes to products used to treat injuries in a potential battlefield setting. Through our collaborative program with the DoD, they've made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma."

Hemorrhage, sometimes accompanied by coagulopathy, is the leading cause of preventable deaths among combat trauma casualties, the release states.

With the order, the use of French FDP is authorized for treating members of the US military for hemorrhage or coagulopathy in emergency combat situations when plasma is not available or its use is not practical.

The FDA says, "If a patient is determined to be in a life-threatening situation requiring intervention and the likelihood of death is high, use of this product would be justified. When practicable, in view of the circumstances of the imminently life-threatening combat casualties and the patient's capacity to make a knowledgeable decision, the patient will be given an option to accept or refuse administration of French FDP. When it is not practicable to do so because of the circumstances, the health care provider will act in the best interest of the patient."

Use of traditional plasma is limited in combat settings because of its need for refrigeration or — in the case of frozen plasma — the need for a long thawing period.

French FDP can be stored for 2 years from the date of manufacture at temperatures between 2°C (36°F) and 25°C (77°F), according to the FDA.

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