MHRA notification regarding Bausch and Lomb UK Emerade pens.
The MHRA has notified Bausch and Lomb UK Limited of reports that Emerade pens (150, 300 and 500 microgram solution for injection in pre-filled syringe) have failed to activate.
We have been asked to make patients aware of this and patients affected are being written to by the practice.
Advice to patients and carers with Emerade pens
- Use the autoinjector at first signs of anaphylaxis. As a precaution you should press the pen very firmly against the thigh.
- If this does not result in activation, you should immediately use your second pen. See Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19) to illustrate what a non-activated pen looks like
- 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. However, if you are having difficulty breathing, you may need to sit up to make breathing easier
- Use second pen if still unwell after 5-15 minutes
- If a further dose of adrenaline is needed before the emergency services arrive, additional attempts should be made to administer a pen that has failed to activate. This is because reports received suggest that a pen may activate after further attempts.
There is also a fact sheet with advice on the use of adrenaline auto-injectors which patients or carers are encouraged to read.
The risk of device mishandling or device failure exists with all adrenaline auto-injectors and is something that patients and carers should be aware of.
The chance of a successful outcome is increased if there is prompt administration of adrenaline at the first signs of anaphylaxis.
Even with an apparently successful response to adrenaline auto-injector administration, patients may relapse some hours later which underlines the importance that the emergency services should always be called.
Published: Oct 11, 2019