Gatwick, UK, 5 July 2017 – Novo Nordisk A/S has detected that the insulin cartridge holder used in a number of NovoPen® Echo® and NovoPen® 5 batches may crack or break if exposed to certain chemicals, for example household cleaning agents. NovoPen® Echo® and NovoPen® 5 are used for insulin treatment by people with diabetes.
Novo Nordisk urges people with diabetes using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to contact Novo Nordisk in order to replace the cartridge holder as some could be damaged or subject to damage in the future if not changed. The batch numbers of the affected batches are listed below.
Using a device with a cracked or broken cartridge holder can result in the device delivering a smaller dose of insulin than expected leading to high blood sugar. The risk of experiencing high blood sugar with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 %, i.e. only 1 in 1000 patients will experience high blood sugar due to an affected cartridge holder.
The warning symptoms of high blood sugar (hyperglycaemia) normally appear gradually and can be: feeling sleepy or tired; dry mouth, urinating more often, feeling thirsty and unintentional weight loss1. You might not experience any physical signs of high blood sugar, but only be able to see it in your blood sugar measurements.
The affected NovoPen® Echo® and NovoPen® 5 batch numbers distributed in the UK are shown below. Please note the batch number can differ on the pen from the box that it comes in.
|NovoPen® Echo®||NovoPen® 5|
|Batch number on carton||Batch number on pen||Batch number on carton||Batch number on pen |
Table 1. List of affected NovoPen® Echo® and NovoPen® 5 batches in the UK.
You can find the batch numbers printed on NovoPen® Echo® and NovoPen® 5 pens (Figure 2) and box (Figure 3) as indicated below.
Figure 2. Red squares show where the batch number is located on (A) NovoPen® Echo® and (B) NovoPen® 5. Please note the pen will need to be dialled up in order to see the batch numbers. The NovoPen® Echo® can be red or blue in colour, whereas NovoPen® 5 can be blue or grey.
If patients are in possession of a NovoPen® Echo® and/or a NovoPen® 5 device with a batch number which is not mentioned above, there is no reason for concern and they can be confident that the pen will work as intended.
Advice for patients using a NovoPen® Echo® and/or NovoPen® 5 with one of the affected batch numbers:
- Do not stop treatment without consulting your doctor.
- Be attentive to your blood sugar levels by checking them regularly and looking for symptoms of hyperglycaemia. If you note these symptoms, measure your blood sugar levels as instructed by your health care provider and take appropriate action.
- In the event that you experience symptoms of too high blood sugar involving this product, contact your doctor for advice.
- To request a replacement cartridge holder, register your contact details (name, address, phone number, email and number of affected cartridge holders) either at the local Novo Nordisk website www.novonordisk.co.uk or contact the Novo Nordisk Customer Care line on 0845 600 5055. Novo Nordisk will extend opening hours of the Customer Care line to include weekends to support patients. Opening hours will be 8am-8pm Mon-Fri and 8am-4pm Sat-Sun.
- You will receive an unaffected cartridge holder for your NovoPen® Echo® and/or NovoPen® 5 within 7 days. Upon receipt, you should attach the new cartridge holder and use as stated in the Instructions For Use.
- Report any adverse events or complaints (including a damaged cartridge holder) to Novo Nordisk’s Customer Care line on 0845 600 5055.
Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory for Novo Nordisk UK and Ireland said, “Novo Nordisk is committed to delivering high-quality products and sincerely apologises for this unfortunate situation and the concerns and inconvenience it may cause patients and health care professionals. We are working closely with the MHRA and UK patient groups to ensure patient safety and minimise the disruption this situation causes.”
If patients have any questions or concerns, please contact your doctor, pharmacist or Novo Nordisk’s Customer Care line on 0845 600 5055. Novo Nordisk will extend opening hours of the Customer Care line to include weekends to support patients. Opening hours will be Mon-Fri 8-8 and Sat-Sun 8-4.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Globally headquartered in Denmark, and at Gatwick in the UK, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.co.uk.