WMT has been made aware of a risk of the Emerade auto injector failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
This issue was first detected in June 2018 during routine stability testing of the syringe component of Emerade with the potential to affect 1.5 in every ten thousand pens; therefore considered a rare event. However, recent information indicates that the potential occurrence of needle blockage in batches on the market is higher than first estimated and so it is being brought to the attention of users.
The full text release from the MHRA can be read here.
The potential for units on the market to have a blockage of the needle which could lead to Emerade failing to deliver a dose when activated is now estimated to be 0.23 %, which would affect 2.3 in every thousand pens. (This estimate is based on simulated laboratory conditions without the auto-injector component which may lower the potential rate of failure to deliver.)
However, because the dose of adrenaline in an adult Emerade auto injector is 0.5mg (0.5ml), even a faulty auto injector is likely to deliver more adrenaline than an Epipen (or Jext / Anapen) device which all routinely have 0.3mg (0.3ml) in them.
The Medicines and Healthcare products Regulatory Agency (MHRA) is not recalling batches of Emerade.
The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade manufactured with all the corrective processes has been introduced into the market from mid-July 2019.
My recommendation is to do nothing but this notice is for awareness and transparency (in case you see other articles in the press on this matter).
Dr Harvey Pynn
Medical Director
31 August 2019