There is a risk of some Emerade syringes failing to deliver adrenaline doses due to blockage of the needle, the Medicines and Healthcare products Regulatory Agency (MHRA) warned as it advised healthcare professionals to contact all affected patients and carers.
The medicines watchdog highlighted the risk in a July 11 drug alert.
The product defect, which affects an estimated 2.3 in every thousand pens, was first identified during product testing in June 2018 but is now judged to be more prevalent than first thought, Bausch & Lomb UK has informed the MHRA.
The potential for blockage is present in Emerade devices of all strengths. It does not apply to other marketed brands of adrenaline auto-injectors.
The MHRA said it would not be recalling Emerade devices, as different auto-injectors require specific training and advice for use and because there are “insufficient supplies available of alternative brands to support the removal of one brand”.
Healthcare professionals are advised to contact all patients and carers who have been supplied with Emerade devices to inform them of the risk and to “reinforce the advice to always carry two in-date adrenaline auto-injectors with them at all time”.
Patients’ risk of being affected by product defects is “substantially reduced” if this advice is followed, the MHRA said.
Lynne regent, CEO of the Anaphylaxis Campaign, advised patients: “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.”