The following are links to the FDA press releases distributed yesterday by the Federal Drug Administration regarding seizure of the Cyanide Antidote Kits (CAK) from Keystone Pharmaceuticals. Do not confuse the CAK with Cyanokit and/or Hydroxocobalamin.
According to the FDA, the Cyanide Antidote Kits (CAK):
1.have not proven safe or effective for their intended use;
2.the kits are also misbranded because their labeling does not contain adequate directions for their use; and,
3.the products are adulterated because they were manufactured under conditions not in compliance with current Good Manufacturing Practice (cGMP) to assure that they meet the identity, quality, an dpurity standards they claim to possess."
Please share this information with those in your EMS and medical networks to expedite removal of the CAK from the pharmaceutical mainstream.
We also encourage you to read the publication, SMOKE: The Toxic Twins of Smoke Inhalation wherein Drs. Augustine, O'Brien, and Walsh discuss the contraindications of CAK administration in the face of smoke inhalation versus that of the Cyanokit (also referred to as Hydroxocobalamin) which has proven to be an effective and safe antidote for acute cyanide poisoning.
For more information:
FDA Warning Letter FDA Inspections, Compliance Enforcement, and Criminal Investigations
Federal Government Seizes Cyanide Antidote Kits from California Company
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