MHRA issues alert for Emerade Adrenaline Auto-Injectors failures
10 October 2019
Products: relates to the Emerade 150, 300 and 500 micrograms solution for injection in pre-filled syringe
The BDA has been notified that a number of Emerade pens (made by an affiliate of Bausch and Lomb UK Limited) have failed to activate meaning the needle is not released from the device and the injection has not administered.
This is not related to the risk of needle blockage reported previously, and the issue with these devices is expected to be resolved soon, as new stock (manufactured since July 2019) is now starting to be released, but it will take some time before all the existing stock in circulation can be replaced.
With this issue, the MHRA is advising that Emerade devices should not be recalled, since there are insufficient surplus devices to replace all the pens that would need to be recalled.
They are advising that, on the basis of all the information available, most pens will activate as normal and they deliver adrenaline as expected and, where patients are concerned, they are advised to continue to follow existing advice to carry two in-date pens with them at all times.
If, however, application does not result in activation, the second pen should be used immediately. If a patient does not improve, suggesting a further dose of adrenaline is needed, additional attempts should be made to administer the pen that has failed to activate, while awaiting the arrival of the emergency services.
For medical information enquiries please contact the Pharmacovigilance and Medical Information Officer on 0208 781 5523 or email.
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