October 4th Update on the position of Emerade Auto Injectors following a review from the MHRA’ - BSACI
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October 4th Update on the position of Emerade Auto Injectors following a review from the MHRA’

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EMERADE 150/300/500 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN- COMPLAINTS OF INITIAL FAILURE TO ACTIVATE

Dear Healthcare Professional,

PharmaSwiss Ceska republika s.r.o. (an affiliate of Bausch and Lomb UK Limited), with the agreement of the European Medicines Agency (EMA) and Medicines & Healthcare products Regulatory Agency (MHRA), wishes to inform you of the following in relation to Emerade 150/300/500 micrograms solution for injection for treating severe acute allergic reactions (anaphylaxis):

Summary

  • The MHRA 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; This risk of needle blockage is expected to be resolved in all new stock manufactured since July 2019
  • 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. Information is provided to patients on page 5.
  • 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.