by Courtney Perkes
The Orange County Register
Federal marshals seized $39,000 worth of unapproved drugs Thursday from a Laguna Hills company, the Food and Drug Administration said.
Keystone Pharmaceuticals refused to heed two warnings from the FDA to stop selling kits for the treatment of cyanide poisoning, according to federal officials. The kits were sold to hospitals although the drugs, made by a San Diego company contracted by Keystone, have not been proven “safe and effective,” the FDA said.
Cyanide poisoning most commonly occurs after inhaling smoke in a residential fire or through fumes during industrial accidents. Treatment typically involves injection of a form of vitamin B-12 that helps the body eliminate the cyanide through urination.
“The FDA is taking this action because Keystone has refused to take these unapproved products off the market,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “This action is a significant step in protecting the public health.”
Keystone officials did not return a call Thursday. The company’s Web site advertises the kits but does not list the price.
The FDA said hospitals that bought the kits should return them to Keystone. The agency has not received any complaints of harmful reactions from the drugs.
Contact the writer: 714-796-3686 or cperkes@ocregister.com

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