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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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has notified Bausch and Lomb UK Limited of reports that Emerade pens have failed to activate. This is not related to the risk of needle blockage reported in the previous drug alert. The risk of needle blockage is expected to be resolved in all new stock manufactured since Jul 2019. 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
The activation failures have not been traced to particular batches. Bausch and Lomb UK Limited are conducting a thorough investigation to identify the reason. Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled. Therefore, at present, the MHRA is advising that Emerade devices should not be recalled. On the basis of all the information available, most pens will activate as normal.
Patients are advised to continue to follow existing advice to carry two in-date pens with them at all times. When an Emerade pen is used, it should be pressed very firmly against the thigh. If this does not result in activation, the patient should immediately use their second pen. If the patient is not improving, suggesting a further dose of adrenaline is needed, additional attempts should be made to administer a pen that has failed to activate, while awaiting the arrival of the emergency services.
An activation failure means that the needle is not released from the device and therefore the injection is not administered. Bausch and Lomb UK Limited are conducting extensive investigations. It has been confirmed that some Emerade pens did not activate when normal force was applied, however the rate of occurrence cannot be accurately estimated at present.
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-57-08-19
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Oct 4, 2019
Issued at HKT 16:00
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