The manufacturer of Emerade 150, 300 and 500 microgram solution in pre-filled syringes are recalling these products. However, the recall only applies to suppliers currently holding batches of these products - it does not apply to individual patients carrying individual pens.
The recall came about after the Medicines and Healthcare products Regulatory Agency (MHRA) notified the manufacturer, Bausch and Lomb UK Limited, of reports that certain autoinjectors had failed to activate.
Subsequent to further investigation by the manufacturer, a recall has now been put in place relating to suppliers only. “The company’s investigations have now shown that an error in one component of the autoinjector is believed to cause some pens to fail to activate and deliver adrenaline.
There is an increased likelihood of the activation fault occurring when pens are exposed to high temperature. Patients should be advised not to expose pens to temperatures above 25°C as this may increase the likelihood of the fault occurring.” *
What action have Treated.com taken?
Following the advice of the MHRA, we have stopped supplying all Emerade products. We are in the process of sending these products back to the manufacturer as has been requested. Until adequate safety notice has been provided from the manufacturer, the product will be discontinued until further notice.
Our patients should be aware that we currently offer EpiPen in 300mcg doses only. We recommend visiting a local pharmacy or other reputable source if you need to obtain an adrenaline pen in a higher or lower dose.
Advice for our patients
We understand this might be concerning for those who may need to use emergency anaphylaxis treatment. We would like to stress to our patients the importance of keeping your Emerade pens below 25 degrees at all times. If you plan on travelling to a hot country, look into ways of keeping your pen cool. You can also speak with our pharmacist if you’re unsure.
Only a very small minority of Emerade pens are thought to have faulty auto-injector components. All action has been taken to minimise the risks relating to the continued supply of these products.
If you currently have an Emerade pen, our advice is to keep it with you and always have 2 pens. There is no need to send your Emerade pen back to your supplier or the manufacturer. Not having a pen at all carries more risk than carrying a faulty pen.
We strongly recommend that all patients carry two pens at all times, as is the advice of the MHRA. They say that “it is important to always carry 2 pens. At the first signs of anaphylaxis, the patient or carer should administer an Emerade pen by pressing it firmly against the thigh. If the pen fails to activate, they should immediately use the second pen."
What happens if I use my Emerade pen?
If you suffer with an anaphylactic shock and you, or a carer, has to administer your Emerade pen call for help straight away. Emergency help should be summoned by dialling 999 and saying “Anaphylaxis” (pronounced anna-fill-axis). While waiting for the ambulance, use your Emerade pen. If it fails to activate then try again, pressing more firmly. If the pen fails or if your symptoms do not start to improve, use your second pen. Discard any used pens safely as soon as you’ve used them.
If all suppliers follow the instructions issued by the MHRA, you will not be able to get a replacement pen however there are alternative brands of adrenaline auto-injector for anaphylaxis, such as EpiPen or others.
Comment from GP Clinical Lead Dr Daniel Atkinson
“Understandably, the recall of these products may be concerning for our patients and others suffering with allergic conditions. We’re taking all appropriate steps to follow the advice and guidance of the MHRA.
The vast majority of people will not be affected by this. I would remind people who currently have Emerade pens in their possession to keep them cool, below 25 degrees, to carry two pens at all times and to replace their Emerade pen with a different brand following its usage.
If anyone feels or concerned, or has additional questions, we are here to support you. You can reach our customer services line on 0207 043 0716, who will be available to answer any questions you may have.” - GP clinical Lead, Dr Daniel Atkinson.
* Medicines and Healthcare products Regulatory Agency (MHRA), “D R U G A L E R T CLASS 2 MEDICINES RECALL”, November, 2019.