Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Bausch & Lomb UK Limited has informed MHRA of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle. The affected products are:
- Emerade 150 micrograms solution for injection in pre-filled syringe
- Emerade 300 micrograms solution for injection in pre-filled syringe
- Emerade 500 micrograms solution for injection in pre-filled syringe
This issue was first detected in Jun 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%). It should be emphasised that two pens are already recommended to be carried at all times in case the patient does not improve after the first injection which may occur for a number of reasons. This notification of potential for needle blockage applies to Emerade devices of all strengths. It does not apply to the other marketed brands of adrenaline auto-injectors. MHRA is not recalling batches of Emerade.
The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade manufactured with all the corrective processes is expected to be introduced into the market from mid-Jul 2019.
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 autoinjectors with them at all times. This advice is provided in the approved patient information leaflet for Emerade, which should be provided to the patient or caregiver at dispensing.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-emerade-150-300-and-500-microgram-solution-for-injection-in-pre-filled-syringe-mdr-55-06-18
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Jul 12, 2019
Issued at HKT 15:00
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