Class 4 MHRA drug alert – Emerade 150/300/500 micrograms solution for injection in pre-filled syringe

Class 4 MHRA drug alert – Emerade 150/300/500 micrograms solution for injection in pre-filled syringe

July 11, 2019

July 11, 2019

Class 4 MHRA drug alert – Emerade 150/300/500 micrograms solution for injection in pre-filled syringe (Bausch & Lomb)

Drug alert number: EL (19)A/17

Date issued: 11th July 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Emerade 150 micrograms solution for injection in pre-filled syringe (Bausch & Lomb)

Emerade 300 micrograms solution for injection in pre-filled syringe (Bausch & Lomb)

Emerade 500 micrograms solution for injection in pre-filled syringe (Bausch & Lomb)

Bausch & Lomb UK limited has informed MHRA of a risk of Emerade products 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. 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%).

Advice for community pharmacy teams:

Healthcare Professionals should contact all patients, and their carers, who have been supplied with an Emerade device to inform them of the potential defect and reinforce the advice to always carry two in-date adrenaline auto-injectors with them at all times.

For stock enquiries please contact Bausch & Lomb Customer Services, Tel: 0208 781 2991, Email: Pharma_CS@bausch.com

For medical information enquiries please contact Lizanne Kombrink (Pharmacovigilance and Medical Information Officer), Tel: 0208 781 5523, Email: Pharmacovigilance.UK@bausch.com

PL number: PL 33616/0013, PL 33616/0014, PL 33616/0015

To view the alert please visit the GOV.uk website.



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