Cyanokit (hydroxocobalamin) 5g powder for solution for infusion: Quality defect due to potential microbial contamination of certain batches resulting in a potential risk of infection.

Summary:

• The manufacturing of Cyanokit has been suspended due to the investigation of an ongoing quality defect. This has resulted in a shortage of the product in the European Union.
• The quality defect involves a potential risk of microbial contamination of certain batches (see below), which could compromise their sterility and lead to a potential risk of infection in patients receiving Cyanokit. 
• While the risk of contamination in these batches cannot be totally excluded, it is considered minimal and outweighed by the benefit of using Cyanokit in cases of acute suspected cyanide intoxication. 
• Healthcare professionals likely to use impacted batches should ensure that:
  • Cyanokit is reserved for patients presenting with clinical signs of acute intoxication in a context suggestive of exposure to cyanide such as inhalation of fire smoke or ingestion of a cyanide salt or cyanogenic product.
  • These include cardiac arrest, shock, respiratory distress, coma, high lactic acidaemia (>8 mmol/L). Cyanokit should not be used in the absence of signs of hypoxia. If systemic infection or sepsis is suspected (e.g., fever, persistent hypotension indicative of shock), initiate blood cultures and start empiric antibiotic therapy, adjusting based on pathogen identification and susceptibility results.