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MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.
The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.
In an alert, published July 11, 2019, the agency revealed that Bausch & Lomb UK, the company that markets the device, had highlighted a risk of the device failing to deliver a dose of adrenaline due to needle blockage in June 2018. However, as it was deemed then to only affect 1.5 in every 10 thousand devices it was considered a rare event.
Recent information, however, has highlighted that the potential for needle blockage is higher than originally estimated and so the issue has been brought to the attention of the patients. Now, it is estimated that 2.3 pens in every thousand may be effected, which has been based on simulated laboratory conditions without the auto-injector component.
Current recommendations are to carry two pens at all times in cases where a patient does not improve after first injection, which is a possibility for numerous reasons other than device failure. The agency reports that if patients continue to follow the recommendations to carry two pens the risk of not being able to deliver a dose of adrenaline is significantly reduced.
The MHRA’s alert is in force for Emerade devices of all strengths and does not apply to other marketed brands of adrenaline auto-injectors. However, the agency is not recalling any batches of Emerade.