Thursday 3rd October 2019
The Medicines & Healthcare products Regulatory Agency (MHRA) has received reports of Emerade pens failing to activate. This means that the needle is not released, and the injection is not delivered.
This is different from the needle blockage issue that you are likely to have been informed about previously by your healthcare professional via a drug alert. This risk is expected to be resolved in all new stock manufactured since July 2019 that will now start to be released to the market.
The cause of the activation failures is being intensively investigated but is currently unknown.
Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled. Therefore, at present, the MHRA is advising that Emerade devices should not be recalled.
The activation failures have not been traced to any particular batches of product.
The MHRA understands that you will be very concerned that the pens in your possession may be affected.
It is important to note that based on all the information to date, the majority of pens will activate as normal.
If you do need to use an Emerade pen, 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. Information is provided below to illustrate what a non-activated pen looks like.
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.
You are reminded to carry two in-date pens with you at all times.
The MHRA and Bausch and Lomb UK Limited will provide updated information to healthcare professionals and affected members of the public as soon as it becomes available.
You can help us by continuing to report any issues directly via the Yellow Card reporting tool, https://yellowcard.mhra.gov.uk
Download the free Emerade mobile app. The free Emerade mobile is available for iPhone and Android phones and includes: Instructions for Emerade, Symptoms of anaphylaxis and Video demonstrations
*Download the app now by visiting the App Store or Google Play and search for “Emerade”.
Reporting a problem
It is easiest and quickest to report ADRs online via the Yellow Card website –
https://yellowcard.mhra.gov.uk/ or via the Yellow Card app available from the Apple App Store or Google Play Store.
Alternatively, prepaid Yellow Cards for reporting are available:
- by writing to FREEPOST YELLOW CARD (no other address details necessary)
- by emailing [email protected]
- at the back of the British National Formulary (BNF)
- by telephoning the Commission on Human Medicines (CHM) free phone line: 0800-731-6789
- by downloading and printing a form from the Yellow Card website (see link above)
When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, and product brand name.
Contacts 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 the Pharmacovigilance and Medical Information Officer, Tel: 0208 781 5523, Email: [email protected]
Further information on Emerade including use of the app can be found at https://www.emerade-bausch.co.uk/
The Anaphylaxis Campaign would like to reinforce the following advice;
- Always carry two adrenaline auto-injectors with you at all times.
- Ensure you have registered the expiry date of your devices on the relevant manufacturers websites to give you ample warning when a new prescription is required.
- Ensure you gain a replacement device prior to disposing of any out of date devices.
- Always make sure you have a trainer device which can be ordered from the manufacturer’s websites for free:
- Make sure that your family and friends are familiar with the device you have and how to use it.
- In an emergency call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna-fill-axis’).
If you have any questions, you can contact our helpline at [email protected] or call 01252 542029 for support from 9am – 5pm, Monday – Friday.