Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle” MHRA (2019).

MHRA report “Bausch & Lomb UK limited has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

This issue was first detected in June 2018 during routine stability testing of the syringe component of Emerade, with potential to affect 1.5 in every ten thousand pens, and therefore considered a rare event. However, recent information indicates that the potential occurrence of needle blockage in batches on the market is higher than first estimated and we are therefore bringing it to the attention of patients.

The potential for units on the market to have a blockage of the needle which could lead to Emerade failing to deliver a dose when activated is now estimated to be 0.23 %, which would affect 2.3 in every thousand pens. (This estimate is based on simulated laboratory conditions without the auto-injector component which may lower the potential rate of failure to deliver.)

However, if the patient follows the existing advice to carry two in-date pens with them at all times, the risk of not being able to deliver a dose of adrenaline before the emergency services arrive is substantially reduced (from 0.23% to 0.000529%).”

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Reference:

MHRA (2019) Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18)