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


There have been questions raised over the last few years about the length of the needles delivering adrenaline/epinephrine via autoinjectors in cases of anaphylactic shock.

To be effective, the adrenaline must be delivered into a large muscle which will propel it speedily around the body. The thigh muscle is ideal, especially in fit young men for whom the injection was originally designed. However, if there is a thick layer of flesh between the skin and the muscle of the recipient (as there could be in a a less fit young man or as there always is in a woman as that is the way that women are built) the needle in the standard autoinjector may not be long enough to reach the muscle. It will therefore deliver the adrenaline under the skin. If this happens it will, effectively, be useless as it will take far too long to reach the muscle and be circulated around the body to reverse the effects of the anaphylactic shock in time. (See this blog for more detail.)

A couple of recent deaths of slim young women for whom adrenaline/epinephrine injections have not worked and the launch of a new auto-injector with a longer needles among other improvements, from Emerade have brought the issue into some focus. Prompted by the UK MHRA, the European Medicines Agency have now set up of a review.

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).

If the Agency decides that the standard needle length is, indeed, too short for some patients this could cause considerable disruption among existing manufacturers all of whose autoinjectors have standard length needles. It could also cause considerable concern among at risk allergics (women and overweight men) who may no longer be able to rely on their Epipens to rescue them quite so reliably if they were to come into contact with their allergen.

Check Emerade for more details on their longer needle injectors.

Check here for Ruth Holroyd's review of the other pens currently available.

For more details on surviving an anaphylactic attack and on how to write an Action Plan see Ruth's article here.

N.B. May 2014
Ruth Holroyd suggests that all women who carry autoinjectors should get an ultrasound check of their thigh to find out how deep their muscle is seated and what is the optimum point for injection. See her blog here.

April 2014

If you found this article interesting, you will find many more articles on anaphylaxis here, and reports of research into anaphylaxis here.
You can also find articles on peanut and tree-nut allergy here, cow's milk allergies here, egg allergy here, histamine intolerance hereand articles on a wide range of other allergic and intolerance reactions to a wide range of other foods here.

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