EpiPen (Adrenaline) Auto-Injector 0.3 Mg: supply of a batch (no. 9FM766) with US-labelled auto-injectors packaged in UK cartons with a UK leaflet
- Mylan has released a batch of US-labelled EpiPen auto-injectors (Batch no. 9FM766) to enable continuous access of auto-injectors in the UK following approval from the MHRA.
- The EpiPen auto-injectors in this batch are affixed with a US label, and are packaged (as single packs) into UK cartons along with UK patient information leaflets.
- The drug name is epinephrine in the US but is known as adrenaline in the UK.
Patients and carers familiar with the term adrenaline may be confused.
Further information on the safety concern and recommendations
The auto-injector device in this batch is exactly the same as the normal UK EpiPen in every way except for the information on the label on the device.
Other differences between the US-labelled and UK-labelled auto-injectors are:
- The UK label has the instruction to ‘Dial 999, ask for ambulance and state ‘anaphylaxis!’, which is replaced with ‘Get emergency medical help!’ on the US label.
- The warning ‘Keep of the reach and sight of children’ is omitted on the US auto-injector label. However, the UK carton and patient information leaflet include this statement.
Please see below a comparison of the US and UK labels on the autoinjectors:
Reminder: Patients and carers should ‘Dial 999, ask for an ambulance and state anaphylaxis!’ after every use of the EpiPen auto-injector.
The label on the EpiPen (epinephrine) auto-injector is meant for the US. Therefore, patients and carers should read the outer carton and enclosed patient information leaflet which is designed for UK patients.
This Important Information leaflet from Mylan explains the difference for patients and healthcare professionals.
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 manufacturer’s 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- Ensure you gain a replacement device prior to disposing of any out of date devices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’).
- All adrenaline auto-injectors (AAIs) come with the following instructions on storage of their device: keeps AAIs in their original containers to prevent light exposure, do not store above 25oC and do not freeze. For EpiPen devices there is an additional instruction to not refrigerate the device.
- Your adrenaline auto-injector devices should be checked regularly to ensure the liquid is clear and colourless. If it appears discoloured or contains particles, the device should be replaced.