FDA Approves Kit to Treat Cyanide Poisoning
Approval of Cyanokit provides new tool to be used in case of terrorism
MONDAY, Dec. 18 (HealthDay News) -- The U.S. Food and Drug Administration has approved Cyanokit for the treatment of known or suspected cyanide poisoning. The product, which contains the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline, will provide a new tool to combat terrorism, according to the FDA.
Cyanokit's active drug takes up cyanide in the body and becomes a form of vitamin B12. Cyanokit was approved under the Animal Efficacy Rule, which allows use of animal data when human testing isn't ethical or feasible. Cyanokit reduced blood cyanide concentration by 55 percent when tested in dogs.
The drug's safety was evaluated in 136 healthy adults. The drug was generally well tolerated with mild-to-moderate side effects such as red skin or urine due to the drug's color or mild allergic reactions that responded to treatment.
"Today's approval is yet another measure to counter the threat of terrorism, which is a critical component of FDA's public health mission," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research in Rockville, Md., said in a statement.
Cyanokit is manufactured for EMD Pharmaceuticals, Inc. by Merck Sante s.a.s. in Semoy, France, and packaged by Dey Laboratories of Napa, Calif.