Cyanokit - supply shortage
Ongoing
hydroxocobalamin
ShortageHuman
Shortage information
There is a supply shortage of Cyanokit in the EU/EAA.
Cyanokit is used as an antidote to treat known or suspected poisoning with cyanide, a highly poisonous chemical. It contains the active substance hydroxocobalamin (vitamin B12a) and is available as a powder to be made up into a solution for infusion (drip) into a vein.
There is a supply shortage because the marketing authorisation holder has suspended the manufacturing of Cyanokit. The suspension is due to a quality defect involving a potential risk of microbial contamination of batches; this could lead to a risk of infection in patients receiving Cyanokit. Although the risk of contamination is considered minimal, the manufacturing of the product has been suspended as a precautionary measure until the company completes its investigation and takes necessary measures.
The shortage is expected to last until May 2025.
The shortage affects all Member States where the product is marketed.
For up-to-date information about the status of a medicine shortage in a particular EU/EEA country, consult the national shortage register or contact the national competent authority.
EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) is closely monitoring the supply situation and engaging with the marketing authorisation holder to identify measures to mitigate the impact of the supply shortage.
In addition, the company has conducted a risk assessment of each batch manufactured during the period affected by the quality defect. While the risk of contamination cannot be totally ruled out, it is considered minimal. In addition, Cyanokit is considered a critical medicine as there is no alternative medicine to treat cyanide poisoning; therefore, batches that have already been distributed will remain on the market.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- Healthcare professionals should be aware of the potential risk of infection in patients who have received an impacted batch of Cyanokit (see list of impacted batches in the direct healthcare professional communication referred to below).
- If systemic infection or sepsis is suspected (e.g., based on fever or persistent hypotension indicative of shock), blood cultures should be started and the patient should be given antibiotic therapy, with adjustments once the pathogen has been identified and susceptibility results are available.
- Currently marketed Cyanokit should be reserved for patients presenting with clinical signs of acute intoxication in a context that suggests exposure to cyanide, such as inhalation of fire smoke or ingestion of a cyanide salt or cyanogenic product.
- Signs of acute cyanide intoxication include cardiac arrest, respiratory distress, coma and high lactic acidaemia (>8 mmol/L).
- Cyanokit should not be used if patients have no signs of hypoxia.
- A direct healthcare professional communication (DHPC) has been sent to healthcare professionals in affected Member States and will also be published on the EMA website.
- For additional information about the supply of Cyanokit, consult your country’s shortage register or contact your national competent authority.
- Due to the supply shortage, healthcare professionals will only use the medicine for patients with clinical signs of acute cyanide poisoning.
- If you have received Cyanokit to treat cyanide poisoning, seek urgent medical attention if you develop signs of infection or sepsis, such as fever, rapid heart rate, slow breathing.
- This is because there is a potential risk of contamination of Cyanokit, which means patients receiving an affected batch of Cyanokit could get an infection. The risk is low and far outweighed by the benefits of treating cyanide poisoning.
- If you have any questions about Cyanokit, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Cyanokit
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- hydroxocobalamin
- Therapeutic area (MESH)
- Hydroxocobalamin
- Pharmaceutical forms affected
- Powder for solution for infusion
- Availability of alternatives
- no
Key dates
- Expected resolution
- May 2025
- First published