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FDA Approves Sodium Thiosulfate Injection for Acute Cyanide Poisoning

FDA Approves Sodium Thiosulfate Injection for Acute Cyanide Poisoning
Photo by Raghavendra V. Konkathi / Unsplash
Key Takeaway
Consider sodium thiosulfate with sodium nitrite for acute life-threatening cyanide poisoning, but weigh risks if diagnosis uncertain.

The FDA has approved Sodium Thiosulfate Injection for sequential use with sodium nitrite for the treatment of acute cyanide poisoning judged to be serious or life-threatening. The drug is indicated as an adjunct to appropriate airway, ventilatory, and circulatory support. When the diagnosis of cyanide poisoning is uncertain, clinicians should weigh the potential risks against benefits, especially if the patient is not in extremis. Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to cyanide-containing compounds, including smoke from closed-space fires. There is no widely available rapid confirmatory blood test, so treatment decisions must be based on clinical history and signs such as altered mental status, mydriasis, seizures, hypotension, and plasma lactate ≥ 8 mmol/L. The approval provides a standardized antidote regimen for this rare but life-threatening emergency.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Sodium thiosulfate acts as a sulfur donor for the enzyme rhodanese, which converts cyanide to thiocyanate, a less toxic compound that is excreted renally. It is used sequentially with sodium nitrite, which induces methemoglobinemia to bind free cyanide.

Indication & Patient Population

Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis is uncertain, potential risks should be carefully weighed against potential benefits, especially if the patient is not in extremis.

Dosing & Administration

Administer without delay if clinical suspicion is high. For adults: 50 mL of sodium thiosulfate immediately following 10 mL of sodium nitrite (given at 2.5-5 mL/min). For children: 1 mL/kg (250 mg/kg, not to exceed 50 mL total) immediately following sodium nitrite (0.2 mL/kg, 6 mg/kg, not to exceed 10 mL). If signs reappear, repeat with half the original dose of both drugs. Monitor blood pressure during infusion. Sodium thiosulfate is chemically incompatible with hydroxocobalamin and should not be administered via the same IV line.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Use with caution if cyanide poisoning diagnosis is uncertain. Comprehensive treatment requires support of vital functions. Safety of administering other cyanide antidotes simultaneously has not been established. Do not administer concurrently in the same IV line.

Place in Therapy

Sodium Thiosulfate Injection is a specific antidote for acute cyanide poisoning, used in conjunction with sodium nitrite. It is an adjunct to supportive care and should be given as early as possible after diagnosis. Expert advice from a poison control center (1-800-222-1222) may be obtained.

Study Details

Study typeFda approval
PublishedFeb 2012
View Original Abstract ↓
1 INDICATIONS AND USAGE Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. Sodium Thiosulfate Injection, an antidote, is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be serious or life-threatening. ( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain. ( 1 )
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