FDA approves drug for treatment of cyanide poisoning

The US Food and Drug Administration has approved a new drug to be used as an antidote to cyanide poisoning.

The FDA granted approval earlier this month for Hope Pharmaceuticals to supply its Sodium Nitrite Injection and Sodium Thiosulfate Injection for the treatment of life-threatening cyanide poisoning.

While sodium nitrite and sodium thiosulfate have been used as antidotes to cyanide exposure, Hope’s Sodium Nitrite Injection and Sodium Thiosulfate Injection are  the first commercially available antidote drugs with these ingredients to be approved by the FDA. The new drugs are subjected to more tests than corresponding drugs that had been previously marketed in the Unites States without FDA approval.

Cyanide is used in mining operations such as heap- and vat-leaching, as well as by artisinal (small-scale) miners who use cyanide-mercury combinations to separate gold particles.

Cyanide – made of carbon and nitrogen – bonds readily with gold, silver and other metals- hence its use by the mining industry.

But the effects of inhaling or ingesting cyanide, or contact with skin and eyes, are immediate and can be potentially fatal.

“Seconds and minutes count when you have an emergency involving cyanide exposure,” said Dr. Craig Sherman, medical director at Hope Pharmaceuticals.

Dr. Sherman said cyanide inhibits the ability of the human body to utilize oxygen, hence the need for an immediate medical response:

“If an operation is known to use cyanide it makes good sense to have on site a supply of a cyanide antidote in the event of an emergency occurring,” he said.

The drugs are affordable, Dr. Sherman noted, which would be important for artisinal mining operations outside the US where miners are often low-paid and safety conditions are substandard or nonexistent.

Hope’s Sodium Nitrite Injection (NDC 60267-311-10) is packaged in a 10 mL vial containing 300 mg of sodium nitrite. Sodium Thiosulfate Injection (NDC 60267-705-50) is packaged in a 50 mL vial containing 12.5 grams of sodium thiosulfate.  Both are available in individually-packaged cartons containing one vial or in an FDA-approved kit (Nithiodote© [NDC 60267-812-00]) which contains a vial of both medications.

 

 

 

 

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