Patients with diabetes should be advised to check their insulin pens or pen cartridges because of quality concerns.
Late on Friday the Medicines and Healthcare products Regulatory Agency issued a drug alert asking diabetes patients to check insulin pens or pen cartridges at home.
The move follows a manufacturing fault that sparked a precautionary recall across Europe of 33 specific batches of insulin pens and cartridges.
The products affected by the European recall are the NovoMix 30 Flexpen 100U/ml pre-filled pen and the NovoMix 30 Penfill 100U/ml cartridge.
The manufacturing problem concerns a fault in the filling of the cartridges, which resulted in some batches of pens and cartridges containing too much or too little insulin.
According to the MHRA, only around 0.14% of the 3.3 million cartridges that are sold across Europe are likely to be affected by the problem so the risk to people in the UK is “likely to limited to a small number of people”.
People with diabetes or their carers can check to see if they have pens or cartridges from the affected batches by looking to see if the following batch numbers are printed on the pen or cartridge: CS6D422, CS6C626, CS6C421, CP50912, CP50750, CP50639, CP51706, CP50940, CP50928, CP50903, CP50914, CP50640, CP51095, CP50904, CP50650, CP51098, CP50915, CP50412, CFG0003, CFG0002, CFG0001, CP50902, CP50749, CP50393, CP50950, CP51025, CP50751, CP50375, CP50420, CP51097, CP50641, CP51096 and CP50392.
Gerald Heddell, the MHRA’s director of inspection, enforcement and standards, said: “Any patients with affected medicines should consult their GP or nurse to make arrangements for a new supply as soon possible.
“In the meantime, it is important that patients do not stop their treatment,” he said.
“They are advised to continue taking their medicine but to measure their blood glucose levels frequently to ensure adequate blood sugar control and that they are in close contact with their carer, a friend or family member who can get medical help if necessary.”
Simon O’Neill, Diabetes UK’s director of health intelligence and professional liaison, added: “The important thing is that anyone affected by this must keep taking their insulin but should get it replaced at the earliest opportunity.”
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