FDA APPROVES DRUG TO TREAT CYANIDE POISONING

The FDA has approved Cyanokit for the treatment of known or suspected cyanide poisoning. The approval, which is based on evidence of the drug's effectiveness when tested in animals, improves the nation's ability to respond to emergencies, including a potential attack by terrorists.

The drug is manufactured for EMD Pharmaceuticals by Merck Santé and packaged by Dey Laboratories.

Cyanokit (hydroxocobalamin) received a priority review and was approved under the Animal Efficacy Rule, which allows use of animal data for evidence of a drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans.

In a controlled study in cyanide-poisoned adult dogs, the use of Cyanokit reduced whole-blood cyanide concentration by approximately 55 percent by the end of the infusion and significantly improved survival compared with placebo.

The safety, metabolism and excretion of Cyanokit were evaluated in 136 healthy adult humans. At the proposed starting dose of 5 grams, the drug was found to be generally well tolerated with side effects that were mild to moderate. In the presence of cyanide, Cyanokit's active drug takes up the cyanide and becomes a form of vitamin B12.