FDA Says Keystone Kits are Unapproved New Drugs, Have Not Been Proven Safe and Effective
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.
Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium Thiosulfate injection and a Sodium Nitrite injection in vials, along with components such as needles, tubing, and a syringe.
Most commonly, cyanide exposure occurs through inhaling smoke in residential fires, or through inhaling cyanide fumes during industrial accidents.
The cyanide antidote kits distributed by Keystone are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and are therefore not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use.
The kits also are misbranded because their labeling does not contain adequate directions for their use. Additionally, the seized 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, and purity standards they claim to possess.
“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.”
In October 2008, the FDA issued a warning letter to Keystone’s contract manufacturer, PrimaPharm of San Diego. That letter identified numerous cGMP violations and informed PrimaPharm that the Keystone Sodium Thiosulfate Injection and the Keystone Sodium Nitrite Injection were unapproved new drugs. The FDA also twice warned Keystone verbally that it should not distribute the unapproved drugs in the cyanide antidote kits.
After an FDA inspection of PrimaPharm between August and September 2009 found continuing cGMP violations, the contract manufacturer said it would no longer accept orders from Keystone to manufacture the injections or kits.
An FDA inspection of Keystone between September and October 2009 revealed that the firm had continued to distribute the unapproved drugs in the cyanide antidote kits still in inventory and did not intend to stop. Keystone was given numerous opportunities to come into compliance, but the company failed to cease distributing the unapproved new drugs.
The FDA advises hospitals or organizations that purchased these products to return the unapproved products to Keystone.
To date, the agency has not received reports of adverse reactions linked to the Keystone cyanide antidote products.
U.S. Food and Drug Administration
July 23, 2010