FDA Approves Nerve Toxin Antidote for Civilians

Duodote counters the effects of insecticides and agents such as sarin

MONDAY, Oct. 2 (HealthDay News) -- The U.S. Food and Drug Administration has approved the use of Duodote (atropine and pralidoxime chloride auto-injector) as an antidote for organophosphorous toxic nerve agents, including sarin and insecticides, in civilian patients. Duodote is manufactured by Meridian Medical Technologies, Inc. in Columbia, Md. In 2002, atropine and pralidoxime chloride were first approved for use in the military as a single injection to counter toxic nerve agents.

The FDA approved Duodote as first-line treatment by trained emergency medical personnel. The intramuscular autoinjector delivers 2.1 mg of atropine and 600 mg of pralidoxime chloride. The atropine blocks acetylcholine's effects on cardiac muscle, the central nervous system and other tissues, while pralidoxime reactivates acetylcholinesterase blocked by some organophosphorous agents and restores cholinergic neural function, according to the FDA approval labeling.

Duodote should be used immediately after the symptoms (tearing, sneezing, muscle fasciculations) appear. There are no absolute contraindications to Duodote after exposure to potentially lethal poisoning with organophosphorous compounds.

"Today's approval facilitates the stockpiling of the product so that it can be used to treat civilians in an emergency, said Douglas Throckmorton, M.D., deputy director of FDAs Center for Drug Evaluation and Research.

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