The European Medicines Agency (EMA) has asked the laboratory Novo Nordisk to withdraw from the market three lots of NOVOMIX 30 FlexPen 100 U / ml due to a quality problem. This is a precautionary measure concerning batches CFG001, CFG002 and CFG003 which expire in September 2014 (09/2014). These insulin pens allow people with diabetes to inject the right dose of insulin when they need it.
“In the affected cartridges, the insulin level can vary between 50 and 150% of the indicated insulin units, which can cause hypoglycemia or hyperglycemia,” explains theEMA in a press release. But “it is important that the patients concerned do not stop their treatment,” she added. If you are in possession of one of these lots, you must give them to a pharmacist who will issue you with a new box in exchange. No adverse effects have been reported to date, but a potential quality defect in the manufacture of the cartridges could lead to overdose or underdose of insulin.
The Danish manufacturer wants to be reassuring and specifies that only 0.14% of cartridges are concerned.
What are the risks ?
Diabetes is caused by excess sugar in the blood. It is insulin that normally helps regulate blood sugar (sugar levels). In case of diabetes, there is an insulin deficiency or resistance to the action of this hormone. The body then becomes unable to use glucose (sugar) for energy. This is why people with diabetes must inject the right dose of insulin to avoid suffering from hypoglycemia or hypoglycemia.
In the event of an overdose, patients may suffer from hyperglycemia which manifests itself in a frequent urge to urinate, a feeling of thirst and uneasiness …
On the contrary, if the insulin cartridge is underdosed, patients may suffer fromhypoglycemia (pallor, headache, rapid heartbeat, tired and unusual weakness …)
