Drug Alert: Emerade
Please see the information below which has been provided by the MHRA and can be found with further information here.
Bausch & Lomb UK limited has informed the MHRA of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
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.
Before use, you can see the solution as clear and colourless in the inspection 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 inspection window. If it fails to activate properly, you may not see the plunger rod appear in the viewing window as you would do normally. Please note however that you may still hear an audible click even it has not worked correctly. If you stlll feel unwell after your first injection you should administer your second pen without delay. 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: Pharma_CS@bausch.com
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 autoinjectors 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-injectorswhich 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.