Adrenaline Auto-injectors to be reviewed by the European Medicines Agency

May 2014

The European Medicines Agency (EMA) has started a review of adrenaline auto-injectors, which are used as first-aid treatment of anaphylaxis (severe allergic reactions) prior to calling for emergency medical  assistance.

This review was requested by the UK medicines agency, the MHRA, following a national review of all adrenaline auto-injector products approved in the UK.  Although the product information of adrenaline auto-injectors states that the devices deliver adrenaline into a muscle, the UK review concluded that there is no robust evidence that this is the case for all patients.  Depending on individual factors such as skin-to-muscle depth, adrenaline may instead be injected under the skin (but not into a muscle), which may result in a different absorption profile (uptake of the medicine by the body).

The European Medicines Agency will now review the available data on the delivery of adrenaline from auto-injectors and on whether the product information contains clear and detailed instructions for appropriate use, and issue an opinion on the marketing authorisations of these medicines across the European Union (EU).

It is important that patients continue to carry an adrenaline auto-injector with which they are familiar, so that they can use it confidently in an emergency if needed. Patients who suffer an anaphylactic reaction should use their injector as prescribed and seek emergency medical assistance straightaway.

Read more on the EMA’s website

We will keep you updated on this review.  If you have any further questions please contact our helpline 01252 542029, info@anaphylaxis.org.uk.