The information below has been provided by the MHRA. Click here to visit the www.gov.uk website article.
Brief description of the problem
Bausch & Lomb UK limited 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. (This estimate is based on simulated laboratory conditions without the auto-injector component which may lower the potential rate of failure to deliver.)
However, if the patient follows the existing advice to 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 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.
This notification of potential for needle blockage applies to Emerade devices of all strengths. It does not apply to the other marketed brands of adrenaline auto-injectors.
The Medicines and Healthcare products Regulatory Agency (MHRA) is not recalling batches of Emerade.
In the UK there are two alternative adrenaline auto-injector devices available. However, the different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices.
Furthermore, there are insufficient supplies available of alternative brands to support the removal of one brand.
The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade manufactured with all the corrective processes is expected to be introduced into the market from mid-July 2019.
Updated Thursday 17th July 2019
How do I know if I have a faulty pen?
All Emerade pens currently on the market have a low risk of being defective but there is no way for the patient to tell by looking at an unused device that it is faulty. Users may be able to check if a dose of adrenaline has been delivered as expected by noting the following:
- Before use, you can see the solution as clear and colourless in the viewing window of the pen by lifting the label.
- If you need to use a pen and it works properly, you will see the plunger rod visible in the whole of the viewing window for the Emerade 300 mcg and 500 mcg autoinjector. The viewing window for the 150 mcg autoinjector will appear yellow from the plunger rod and spacer component of the autoinjector.
- The plunger rod is of different colour for each strength of the Emerade autoinjector: blue for Emerade 500 mcg; green for Emerade 300 mcg and yellow for Emerade 150 mcg.
- If it fails to activate properly, you may not see the plunger rod or the plunger rod may not ‘fill’ the whole of the viewing window as it would do normally. You may also see a yellow spacer, which is a component of the autoinjector, in the viewing window for Emerade with needle blockage. Please note however that you may still hear an audible click even it has not worked correctly.
- It might be difficult to differentiate the viewing window for the 150 mcg Emerade pen between a successful activation (a pen without needle blockage) and unsuccessful activation (a pen with needle blockage). Therefore in all cases it is important that if you stlll feel unwell after your first injection you should administer your second pen without delay (5-15 minutes according to the patient leaflet). You should make sure you carry two devices at all times.
Pens are currently being manufactured with full corrective actions. The company has advised that Emerade manufactured with all the corrective processes will be introduced into the market from mid-July 2019. For enquiries regarding stock, please contact Bausch & Lomb Customer Services, Tel: 0208 781 2991 Email: [email protected]
Action for healthcare professionals and patients
Healthcare Professionals should contact all patients, and their carers, who have been supplied with an Emerade device to inform them of the potential defect and reinforce the advice to always carry two in-date adrenaline auto-injectors with them at all times.
This advice is provided in the approved patient information leaflet for Emerade, which should be provided to the patient or caregiver at dispensing.
Patients experiencing any problem with Emerade failing to activate should report this via the MHRA’s Yellow Card Scheme and keep the pen for further examination.
Additional advice to patients
Additional advice to reiterate to patients is 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
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.
Contact details for further information
For stock enquiries please contact Bausch & Lomb Customer Services:
Tel: 0208 781 2991 Email: [email protected]
For medical information enquiries please contact Lizanne Kombrink, Pharmacovigilance and Medical Information Officer:
Tel: 0208 781 5523 Email: [email protected]