4th March 2020
The UK’s regulator of medicines (Medicines & Healthcare products Regulatory Agency [MHRA]) has received updated information from the company that makes Emerade pens about the defect previously reported by the MHRA. The defect means some pens may fail to activate and therefore will not inject adrenaline. Recent results from tests on unused pens returned by patients indicate that approximately 13% of pens (13 in 100) need higher than normal force to activate. This implies a higher risk of failure to activate than was previously estimated.
For Emerade 150 micrograms auto-injectors, the MHRA, in conjunction with the Department of Health & Social Care (DHSC) has established that there are sufficient supplies of alternative auto-injectors to allow for a recall to patient level. Emerade 150 micrograms auto-injectors is a product intended for use in children who weigh between 15 kg and 30 kg (typically aged 3 to 10 years).
The MHRA has issued advice for patients with an Emerade 150 microgram auto-injector which can be downloaded here
Emerade 300 microgram and Emerade 500 microgram auto-injectors are not being recalled at present as there are insufficient supplies of alternatives to provide replacements. For all patients currently in possession of higher strengths of Emerade auto-injectors (i.e. 300 or 500 microgram auto-injectors), the advice from MHRA and DHSC remains that the risk to the patient of being left without a pen, and therefore having no adrenaline to administer, is greater than allowing them to keep pens that may not activate, especially if two pens are carried. Although the risk of activation failure is now estimated to be higher than was previously reported, most Emerade pens will still activate as intended. Therefore, patients should be advised to retain their unexpired Emerade pens, to avoid being left without access to any adrenaline pens. Further MHRA drug alerts will be issued with immediate effect, as soon as supplies of alternatives are able to meet the demand for replacement of all the remaining Emerade pens held by patients.
The MHRA has issued advice for patients with an Emerade 300/500 microgram auto-injector which can be downloaded here
If you have any questions, you can contact our helpline at [email protected] or call 01252 542029 for support from 9am – 5pm, Monday – Friday.
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’).
- All three 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.