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MHRA alert regarding N-butyl-2-cyanoacrylate (Histoacryl)
The MHRA has issued an alert regarding N-butyl-2-cyanoacrylate (Histoacryl) after being notified about problems with batches that have failed to polymerise when deployed. They have also warned of potential supply problems in the near future. Cyanoacrylate is recommended in the BSG 2015 guidelines for the management of gastric variceal haemorrhage in cirrhotic patients (level 1a, grade A). Thrombin can also be considered, albeit with a weaker evidence base (level 4, grade C). Many units around the UK already use thrombin (FlosealTM) and Endoscopy Units may wish to consider having this available as an alternative to cyanoacrylate for patients with bleeding gastric varices until the situation is resolved.
The BSG does not routinely issue drug or device alerts but in this instance, all members should be aware of the problems with Histoacryl to allow forward planning, given the often life-threatening and emergency nature of gastric variceal haemorrhage.
Ian Penman, VP Endoscopy
John Dillon, VP Hepatology
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