MHRA issues important alert for Emerade 300mcg and 500mcg auto injectors

7th April 2020

This is a different alert to that issued on 04 March 2020 for Emerade 150 microgram auto-injectors.

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.

This is a recall for Emerade 300 microgram pens only. Advice for patients with an Emerade 300 microgram auto injector can be downloaded here.

Healthcare professionals should inform patients and carers that they should therefore return all in-date Emerade 300 micrograms auto-injectors to their local pharmacy once they have obtained a prescription for, and been supplied with, an alternative brand.

The MHRA has issued action for healthcare professionals that can be downloaded here

At the point of prescribing and dispensing, it is vital that patients and carers receive training to ensure they are completely familiar with the use of the new device. This is because each brand of adrenaline auto-injector is used differently. Patients should continue to carry two devices at all times. in case of a need to administer a second dose of adrenaline before the arrival of the emergency services.

Guidance on the use of adrenaline auto-injectors in schools:

For more information on the use of adrenaline auto-injectors in schools, see the link below: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/645476/Adrenaline_auto_injectors_in_schools.pdf

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 Emerade 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. Advice for patients with an Emerade 500 microgram auto-injector can be downloaded here: Emerade 500mcg Patient Letter

What to do if you suspect anaphylaxis

• use your adrenaline pen immediately or ask someone else to do this if you prefer (any person is legally allowed to administer adrenaline to another person to save a life);
• call an ambulance (999) immediately after giving the injection or ask someone to do this. Say this is an emergency case of anaphylaxis (pronounced “anna-fill-axis”);
• use your second adrenaline pen 5 to 15 minutes after the first pen if you are not improving or if you start to deteriorate after an initial improvement;
• use your second adrenaline pen immediately if an Emerade pen fails to activate despite pressing firmly against the thigh;
• if you are not improving and need a second dose, keep trying to use a failed Emerade pen while waiting for the ambulance, even if one pen has activated

If you have any questions, you can contact our helpline at info@anaphylaxis.org.uk or call 01252 542029 for support from 9am – 5pm, Monday – Friday.