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Allergy patients who carry a particular type of adrenaline auto-injector pen that has been found to be faulty should be advised to seek replacement pens of a different brand, according to safety regulators.
The Medicines and Healthcare products Regulatory Agency (MHRA) said healthcare professionals were being asked to contact patients who use Emerade 500 microgram pens.
Both patients and 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, said the MHRA.
“It is vital that patients follow existing advice to carry two pens with them at all times”
The recall has been sparked by reports of difficulty in activating the pens, meaning the dose of adrenaline may not be delivered when needed by a patient for anaphylaxis.
The MHRA’s alert stated: “Results from manufacturer testing of Emerade auto-injectors recalled from patients in Europe indicate that approximately 13% of pens need higher than normal force to activate, implying a higher risk of activation failure than was previously understood.”
Most of the pens will still activate, but more force may need to be applied, warned the MHRA. The recall of Emerade 500 microgram auto-injectors also follows the previous recalls of Emerade 150 and 300 microgram auto-injectors.
The pens were recalled in three phases to ensure there would be enough supplies of the alternative pens, EpiPen or Jext, available for patients, noted the MHRA.
It highlighted that alternative brands of adrenaline auto-injector (EpiPen and Jext) were available in a maximum strength of 300 micrograms.
The MHRA said data showed that a single EpiPen (300 microgram) or Jext (300 microgram) pen would be a “suitable replacement” for a single Emerade 500 microgram pen.
This is based on results from a study that compared blood levels of adrenaline following EpiPen 300 micrograms or Jext 300 micrograms with that following Emerade 500 micrograms.
An 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.”
They said patients should be advised to return all relevant pens to their local pharmacy once they have a new prescription and had 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,” the spokesperson.
“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,” they added.
But, given the Covid-19 crisis, the MHRA advised that healthcare professionals were unlikely to be able to help with face to face training but there may be opportunities for remote consultations.
“Action has been taken to protect patients, following detection of a fault in one component of the Emerade adrenaline auto-injector pens”
Patients must be encouraged to take particular care to read the instructions on how to use the new pen which can be found in the leaflet contained in the box, the MHRA noted.
It highlighted that the manufacturers’ websites for each brand of pen had information and training videos, while trainer pens could be obtained from the manufacturer.
The MHRA added that, if an Emerade pen did need to be used before a patient was 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,” warned the authority in its safety alert.