Advisory - Important safety information for people with diabetes using NovoPen Echo or NovoPen 5

OTTAWA, July 25, 2017 /CNW/ -

Issue
Health Canada is advising Canadians that Novo Nordisk A/S has updated a voluntary recall of insulin cartridge holders used in certain lots of its NovoPen Echo and NovoPen 5 insulin pens. The company detected that the cartridge holders may crack or break if exposed to certain chemicals, such as some cleaning agents.

Affected Products
NovoPen Echo:


    Device Lot Number              Package Lot
                                   Number
    -----------------             -----------

    DUG2373                       DUG2373-5

    DVG1368                       DVG1368-B

    EVG2915                       EVG2915-7

    EVG3010                       EVG3010-2

    EVG4252                       EVG4252-6

    EVG5699                       EVG5699-6

    EVG5946                       EVG5946-7

    EVG5963                       EVG5963-1

    FVG7337                       FVG7337-2

    FVG7561                       FVG7561-1

    FVG8131                       FVG8131-5

    FVG8132                       FVG8132-6

    FVG8212                       FVG8212-1

    FVG8414                       FVG8414-9

    FVG8994                       FVG8994-1

    FVG8997                       FVG8997-1
    -------                       ---------

NovoPen 5:


    Device Lot Number             Package Lot Number
    -----------------             ------------------

    EVG5564                       EVG6240
                                  EVG6241
    EVG3337                       FVG6867
                                  FVG6868
    EVG5564                       FVG7469
                                  FVG7568
    EVG0915

    FVG7336

    FVG7377
    -------

Background
Novo Nordisk A/S has advised that using a device with a cracked or broken cartridge holder can result in a smaller dose of insulin than expected, which may lead to hyperglycemia (high blood sugar). According to Novo Nordisk A/S, 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 per cent. This means that less than one in 1,000 patients with an affected cartridge holder will experience high blood sugar.

Warning symptoms of high blood sugar include: flushed, dry skin, sleepiness or tiredness, dry mouth, breath that smells fruity or like acetone (nail polish remover), frequent urination, feeling thirsty, loss of appetite, nausea, and vomiting. It is possible that high blood sugar may only be seen by measuring blood sugar levels, and may not display any physical signs.

Novo Nordisk A/S has confirmed that the cartridge holder issue does not affect NovoPen Echo or NovoPen 5 devices with a lot number that is not mentioned above.

What consumers should do

    --  Do not stop treatment without consulting your health care professional.
    --  Contact Novo Nordisk Customer Service in order to receive an unaffected
        cartridge holder for your NovoPen Echo or NovoPen 5 product, or if you
        have any questions about this recall. You can contact the company by
        calling 1-800-465-4434, emailing NNCI_CustomerCare@novonordisk.com, or
        by completing the form on the company's website.
    --  In the event that you experience symptoms of high blood sugar or any
        health concerns involving this product, contact your healthcare
        professional for advice. Measure your blood sugar levels as instructed
        by your healthcare professional, and more frequently if symptoms of high
        or low blood sugar develop unexpectedly.
    --  Report complaints about health products to Health Canada by calling
        toll-free at 1-800-267-9675, or complete an online complaint form.

Related Links

Recall - NovoPen 5 and NovoPen Echo

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SOURCE Health Canada