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Product Information

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.

For more information on the use of adrenaline auto-injectors in schools, see Auto Injectors in Schools - More information can be found in Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20). Information on Emerade 500 microgram auto-injectors It is recommended that you carry two AAIs at all times, this is particularly important for people who have allergic asthma and a food allergy as they are at an increased risk of a severe allergic reaction.1 GOV.UK. Available at https://www.gov.uk/government/publications/public-assessment-report-recommendations-to-support-the-effective-and-safe-use-of-adrenaline-auto-injectors/public-assessment-report-of-the-commission-on-human-medicines-adrenaline-auto-injector-expert-working-group-recommendations-to-support-the-effectiv. Last Accessed: May 2023

The recall of Emerade 300 microgram auto-injectors from patients follows a previous recall of Emerade 150 microgram auto-injectors from patients. See more information in the previous alert.

General Practitioners (GPs) should send the letter “Advice for patients with an Emerade 300 microgram auto-injector” in the document attached below, to all patients and carers, as appropriate, who have been prescribed Emerade 300 micrograms auto-injectors. 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 500 microgram auto-injectors are not being recalled. Unless previously actioned during the Emerade 150 microgram recall, GPs should send the attached letter “Advice for patients with Emerade 500 microgram auto-injectors” in the document attached below, to those patients who have been prescribed Emerade 500 microgram auto-injectors, for information. This information is available as separate PDFs in the link for this alert. Actions for healthcare professionals There are two types of AAIs available in the UK, these are called Epi-Pen and Jext. They both contain the same type of medication called ‘adrenaline’ (also referred to as ‘epinephrine’) which is given by injection, into the outer midthigh muscle. AAIs are prescription only medicines, and need to be prescribed by a healthcare professional –usually your GP or allergy specialist. The dose of adrenaline required is dependent on the age and weight of the person requiring the AAI device, and will be prescribed by the doctor. It is important that AAIs prescribed for children are reviewed as they get older and increase in weight to ensure they have the correct dose. Each AAI device will differ in appearance and the availability of the dose/strength available in that particular brand.General Practitioners (GPs) should send the attached Patient Letter – Advice for patients with an Emerade 150 microgram auto-injector to all patients and carers, as appropriate, who have been prescribed Emerade 150 micrograms auto-injectors. Patients and carers should be told of the important differences between brands of adrenaline pen in how they are used. 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.