Medicines Healthcare Products Regulatory Agency
Patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should immediately contact their GP to obtain a prescription for, and be supplied with two 300 microgram or 500 microgram auto-injectors of a different brand. Pharmacists and pharmacy teams can also help with obtaining new prescriptions and dispensing of new pens. Patients or carers should then return all Emerade 300 and 500 micrograms auto-injectors to their local pharmacy.
Patients should only return their Emerade pens when they have received a replacement from their pharmacy which will be an alternative brand - either EpiPen or Jext. They should ensure they know how to use the replacement pen, as each brand of pen works differently. Patients should ask their doctor, pharmacist, or nurse for help with this. Instructions are included inside the pack, along with details of the manufacturers website that also provides information, including videos, on how to use a new EpiPen or Jext adrenaline pen.
This precautionary recall is because some 300 microgram and 500 microgram Emerade auto-injector pens may rarely fail to activate if they are dropped, meaning a dose of adrenaline would not be delivered. Premature activation has also been detected in some of the 300 microgram and 500 microgram pens after they have been dropped, meaning that a dose of adrenaline is delivered too early.
The activation failure and premature activation was detected during a design assessment conducted by the manufacturer and therefore means there is a potential for some 300 microgram and 500 microgram Emerade pens to fail during use after having been dropped.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Patient safety is our top priority.
We are taking prompt action to protect patients, following detection of damage to internal components of the Emerade pens if they are dropped, which may mean they activate too early or fail to activate and deliver adrenaline.
The Department for Health and Social Care has confirmed that there are appropriate supplies of EpiPen or Jext adrenaline pens available for patients across the UK, however, patients will need to request a new prescription.
Patients are reminded to carry two pens with them at all times as normal and to contact their healthcare professional when a replacement is due.
Further information for patients and carers on what to do if they suspect anaphylaxis is available on the MHRAs Adrenaline Auto-Injectors (AAIs) safety campaign.
Additional information
1. Exposure to high temperature may increase the risk of pen failure. Emerade pens should not be exposed to temperatures above 25C, such as being placed near to a radiator or fire. If travelling to a hot climate, patients should visit their doctor to obtain a prescription for an alternative brand of adrenaline pen.
2. Emerade pens that are dropped or vigorously handled may fail to activate or may prematurely activate. General advice states that users should inspect the pen if dropped and replace if they notice damage or leakage. This recall considers that damage within some pens may not be visible and therefore a precautionary patient-level recall is being carried out.
3. If an Emerade pen does need to be used, it should be pressed very firmly against the thigh. If this does not result in activation, the patient should immediately use their second pen. More detailed information for patients is available on the MHRA website. This includes images showing users what an activated pen looks like, compared to a non-activated pen.
4. Training videos on how to use the 0.15mg EpiPen and 0.3mg EpiPen and Jext 150 pen and 300 pen are available on the respective manufacturers websites.
5. Since May 2021, there have been no Yellow Card reports of Emerade 300 microgram or 500 microgram pens prematurely activating or failing to activate.
Notes to editors
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care (DHSC) have taken the action following receipt of evidence from the manufacturer, Bausch & Lomb UK Limited, which showed the premature activation and activation failure of some Emerade pens after they were dropped during a design assessment.
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The MHRA issued a patient-level recall of Emerade pens on 9th May 2023, and included advice that can be shared with patients to ensure they request a new prescription and received alternative brands.
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Emerade is a brand of adrenaline auto-injector (AAI) pen for the emergency treatment of anaphylaxis. It is available in two strengths of 300 microgram and 500 microgram per dose.
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The Yellow Card Scheme is MHRAs system of monitoring the safety of medicines in the UK and it acts as an early warning system to identify new, and strengthen existing, safety information about medicines. Yellow Cards are used alongside other scientific safety information to help MHRA to take action, if necessary, to make changes to the warnings given to people taking a medicine or review the way the medicine is used to maximise benefit and minimise the risk to the patient.
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For media enquiries, please contact the newscentre@mhra.