Allergy patients are being advised of an urgent safety alert following reports to the Medicines & Healthcare products Regulatory Agency (MHRA) that Emerade pens are failing to activate.
The latest problem involves the needle not being released, and the injection therefore not being delivered.
This is different from the needle blockage issue that you are likely to have been informed about previously during the summer (read that here). That risk is expected to be resolved in all new stock manufactured since July 2019 that will now start to be released to the market.
The cause of the recent activation failures is being intensively investigated but is currently unknown.
Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled. Therefore, at present, the MHRA is advising that Emerade devices should not be recalled.
The MHRA understands that allergy patients will be very concerned that the pens in their possession may be affected. It is important to note that based on all the information to date, the majority of pens will activate as normal.
Allergy patients are being advised that if they do need to use an Emerade pen, as a precaution they should press the pen very firmly against the thigh. If this does not result in activation, they should immediately use their second pen.
If a further dose of adrenaline is needed before the emergency services arrive, additional attempts should be made to administer a pen that has failed to activate. This is because reports received suggest that a pen may activate after further attempts.
Allergy patients are reminded to carry two in-date pens with them at all times.
A full investigation is ongoing.