Allergy patients who carry Emerade 500 microgram adrenaline auto-injector pens should contact their prescriber and seek replacement pens of a different brand.
Healthcare professionals are being asked to contact patients who use Emerade 500 microgram pens following notification by the Medicines and Healthcare products Regulatory Agency (MHRA).
Patients and/or carers should return all Emerade 500 micrograms auto-injectors to their local pharmacy once they have obtained a prescription for, and been supplied with, an alternative brand.
The recall is due to reports of difficulty in activating the pens, meaning the dose of adrenaline may not be delivered when needed by a patient for a severe, acute allergic reaction (anaphylaxis). Most of the pens will still activate, but more force may need to be applied.
The recall of Emerade 500 microgram auto-injectors follows the previous recalls of Emerade 150 and 300 microgram auto-injectors. More information on the previous alerts can be found on the following links: 150mcg recall and 300 mcg recall.
The pens were recalled in three phases to ensure there would be enough supplies of the alternative pens, EpiPen or Jext, available for patients.
Alternative brands of adrenaline auto-injector (EpiPen and Jext) are available in a maximum strength of 300 micrograms.
There are data to show that a single EpiPen (300 microgram) or Jext (300 microgram) pen will be a suitable replacement for a single Emerade 500 microgram pen.
This is based on recently available results from a study that compared blood levels of adrenaline following EpiPen 300 micrograms or Jext 300 micrograms with that following Emerade 500 micrograms. Patients should always carry two pens.
A MHRA spokesperson, said:
Action has been taken to protect patients, following detection of a fault in one component of the Emerade adrenaline auto-injector pens.
Patients should return all Emerade 500 microgram pens to their local pharmacy once they have a new prescription and have been supplied with pens of an alternative brand.
It is vital that patients follow existing advice to carry two pens with them at all times and to contact their doctor when a replacement is due.
When switching to a different brand of adrenaline pen the patient must ensure they are familiar with how to use the pen as each brand is administered differently.
Given the current COVID-19 pandemic, the MHRA in line with NHS guidance, is urging patients who need to return auto-injector pens to minimise additional burden on healthcare professionals and heed the advice on social distancing.
- a patient or carer should make a telephone appointment with their doctor to request a prescription for replacement pens of a different brand. Unless their doctor advises otherwise, they should not visit the GP surgery in person
- request the prescription is sent to a pharmacy to avoid collecting in-person from the surgery
- if a patient and/or their household is self-isolating, ask a friend or relative to collect the replacement pens from the pharmacy. Some pharmacies offer a home delivery service
- once the patient has the replacement auto-injector pens return Emerade 500 mcg pens to the pharmacy. Some pharmacies have drop-off boxes to facilitate distancing.
At present, healthcare professionals are unlikely to be able to help with face to face training but there may be opportunities for remote consultations. Patients must take particular care to read the instructions on how to use the pen which are in the leaflet contained in the box.
The manufacturers’ websites for each brand of pen have information and training videos on how to use the auto-injector.
Trainer pens can be obtained from the manufacturer and patients are strongly urged to get these so they can practise with the new device.
If an Emerade pen does need to be used before a patient is able to obtain an alternative pen, it should be pressed very firmly against the thigh. If this does not result in activation, the patient should immediately use their second pen.