Allergy patients are being advised of an urgent safety alert. The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a risk of Emerade products failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
The products affected in the safety alert are:
Emerade 150 Micrograms Solution For Injection In Pre-Filled Syringe; Emerade 300 Micrograms Solution For Injection In Pre-Filled Syringe And Emerade 500 Micrograms Solution For Injection In Pre-Filled Syringe
It is estimated that about 2.3 in every thousand pens could be affected.
However, if patients follow the existing advice to ALWAYS carry two in-date pens with them at all times, the risk of not being able to deliver a dose of adrenaline before the emergency services arrive is reduced.
This issue was first detected in June 2018 by the pens' makers, Bausch & Lomb, and it was decided then, that the risk affected only about 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, as described above.
It is important that patients observe the guidance to carry the recommended two pens at all times in case the patient does not improve after the first injection which may occur for a number of reasons.
This safety alert applies to Emerade devices of all strengths. It does not apply to other marketed brands of adrenaline auto-injectors.
The Medicines and Healthcare products Regulatory Agency (MHRA) is not recalling batches of Emerade.
Additional advice for patients
- 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
There is also a fact sheet with advice on the use of adrenaline auto-injectors
which patients or carers are encouraged to read.