Allergy patients are being advised to carry two adrenaline auto-injector devices at all times following the discovery of blocked needles, which the Medicines and Healthcare products Regulatory Agency (MHRA) say cannot deliver the pens’ adrenaline.
The fault was first identified in June 2018 during a routine testing of the Emerade adrenaline pens by the manufacturers Bausch & Lomb. However, it was concluded that the defect was very rare, affecting only 15 in every 100,000 pens.
Further testing has since shown that the fault actually affects an average estimate of 230 pens per 100,000.
It is confirmed that all strengths of solution for Emerade pens (i.e. 50mcg, 300mcg and 500mcg) could be affected.
No batches are being recalled, but the MHRA says that the risk of being unable to deliver a dose of adrenaline falls to almost nothing at 0.23% to 0.000529% if patients follow the advice to carry two pens at all times.
Actions to take
The pens are used to treat severe, life-threatening allergic reactions, which have several causes, including eating foods containing nuts, milk, eggs and fish, and through insect stings or medicines.
Three brands of adrenaline pens are available in the UK – Emerade, EpiPen and Jext – all of which can be used to treat someone suffering from a severe allergic reaction.
The MHRA said: “Healthcare professionals should contact all patients, and their carers, who have been supplied with an Emerade device, to inform them of the potential defect and reinforce the advice to carry two in-date adrenaline auto-injectors with them at all times.”
Bausch & Lomb has also taken action and pens manufactured under the new procedures are to be released onto the market this month.
Lynne Regent, from the Anaphylaxis Campaign charity, said: “We would like to take this opportunity to remind all individuals who are prescribed an adrenaline auto-injector to always carry two devices at all times, to use your auto-injector at the first signs of anaphylaxis and to call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna-fill-axis’).”
Patients carrying any adrenaline pen are advised to do the following:
• Check the device’s expiry date and be sure to replace it before it expires
• Once you have called 999 in the case of anaphylaxis, lie flat if possible, with your legs up to keep blood flowing
• If you still feel unwell after five to 15 minutes, use your second pen
Inez Brown, partner and Head of Clinical Negligence with Medical Accident Group, said: “Although life-threatening allergic reactions can be caused by a number of reasons, the fault that has been identified with these adrenaline auto-injectors is of great concern and hopefully allergy patients will heed the warning by having two allergy pens with them at all times.”
If you or a family member have suffered from poor treatment, Medical Accident Group can help. We have a team of dedicated clinical negligence solicitors who will guide you through the process of making a claim. Call the team now on 0800 050 1668 or email at firstname.lastname@example.org