Bausch & Lomb UK limited (the makers of Emerade) has informed us of a risk of Emerade product 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 potential to affect 1.5 in every ten thousand pens, and 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 we are therefore bringing it to the attention of patients.
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. However, if you follow the existing advice to carry two in-date pens with you at all times, the risk of not being able to deliver a dose of adrenaline before the emergency services arrive is substantially reduced (from 0.23% to 0.000529%).
It should be emphasised that two pens are already recommended to be carried at all times in case the patient does not improve after the first injection which may occur for a number of reasons.
We would advise you to:
- Check expiry date and replace the pen before it expires
- Use the autoinjector at first signs of anaphylaxis
- Call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna -fill-axis’)
- Lie flat if possible with your legs up to keep your blood flowing
- Use second pen if still unwell after 5-15 minutes
Please click on the link below for further information:
https://assets.publishing.service.gov.uk/media/5b644e25ed915d377695c83d/AAI-PDF-v4.pdf