The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for Bausch & Lomb’s Emerade adrenaline auto-injector device.
Bausch & Lomb UK have notified the MHRA about a fault that is present within some of the Emerade products, due to a failure to deliver the adrenaline dose from the syringe because of a needle blockage within the device.
The first issue was detected in June 2018 during the routine stability testing of the syringe component in Emerade. At the time it was classed as a rare issue, due to its frequency being anticipated as 1.5 in every ten thousand pens being affected. However, it is believed that more pens may be affected than first thought.
Recent reports claim that around 0.23% of Emerade pens could be affected – that's 2.3 in every 1000 pens. However, it’s claimed that if a patient carries two in-date pens with them the risk of not being able to deliver an adrenaline dose before emergency services arrive is reduced from 0.23% to 0.000529%.
The MHRA is not recalling batches of Emerade as there are only two other adrenaline auto-injector devices on the market, and these are not used in the same way, meaning that in order to use these alternative devices training and advice would be required. Additionally, there are not sufficient supplies available of these alternatives to allow the removal of Emerade auto-injectors from the market.
The UK government is calling for all healthcare professionals to contact patients, and their carers who have been supplied with the Emerade device to notify them of the potential defect, and reinforce the advice to carry two devices which are in-date at all times. Additionally, all patients are encouraged to report any issues to the MHRA via the yellow card scheme, and keep the faulty pen for further inspection.
The additional advice issued to patients is as follows:
- Check expiry date and replace the pen before it expires
- Use the autoinjector at first signs of anaphylaxis
- Call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna -fill-axis’)
- Lie flat if possible with your legs up to keep your blood flowing
- Use second pen if still unwell after 5-15 minutes
Lynne Regent, CEO of the anaphylaxis campaign commented: “The anaphylaxis campaign recognises this is a very difficult time for patients who carry Emerade auto-injectors. We would like to take this opportunity to remind you and 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’)."
The government claim that Emerade’s manufacturer has carried out extensive investigations and implemented corrective actions. From mid-July 2019, an Emerade manufactured with corrective processes is anticipated to be introduced to the market.