Diabetics Recall of insulin preparation NovoMix 30

Drug Agency Recalls Insulin Syringes - Life-threatening hypoglycaemia possible

25/10/2013

The Federal Institute for Drugs and Medical Devices (BfArM) has the insulin preparation „NovoMix 30 FlexPen“ recalled. According to the BfArM, the insulin dose may be based on the information provided by the manufacturer Novo Nordisk for the affected batches of the drug „between 50 percent and 150 percent of the specified concentration“, which makes a correct adjustment of the blood sugar level in diabetes patients virtually impossible. In the worst case, use could have life-threatening consequences.

Due to a production error in certain batches of NovoNordisk's insulin pens, insulin doses in the pre-filled syringes that are too low or too high are possible according to the BfArM. Overall, around 1,000 pens are affected by the batch numbers CP50393, CP50749 and CP50902. These batches were also delivered to Germany. Depending on whether the insulin dose is too high or too low in the pre-filled syringes, either high blood sugar (if the insulin dose is too low) or too low blood sugar (if the insulin dose is too high) may result.

Health risks due to wrong insulin dose
Both hypoglycaemia and hypoglycaemia are associated with certain health risks. However, if the diabetes patient is given too little insulin due to a defective pre-filled syringe, the occurrence of acute symptoms of hyperglycemia (high blood sugar levels) is, according to the BfArM „unlikely, especially in patients with type 2 diabetes, who make up the majority of NovoMix 30-treated patients.“ Although patients with type 1 diabetes tend to be more affected by a wrong dosage, but here too, according to the experts, only symptoms such as an increased feeling of thirst, increased urine production or dizziness can be expected. The BfArM classifies the risk of too high an insulin content of the preparations as much more serious. These could „Patients with type 1 and type 2 diabetes alike“ and lead to the onset of severe hypoglycaemia (very high levels of hypoglycaemia), which in turn can trigger convulsions or even a life-threatening shock (so-called sugar shock).

Risk of life-threatening hypoglycemia
„While the risk of severe hyperglycemia is considered to be relatively low and manageable, the use of a cartridge with too high an insulin concentration could potentially induce lethal hypoglycaemia“, writes the BfArM. Could also „in the worst case scenario, a patient switching from a 50 percent to low concentration pen would switch to a 50 percent high concentration, and thus acutely increase the dose of insulin three times“, so the warning of the drug agency. Patients or caregivers should therefore thoroughly inspect the lot number of the pen.

Replace preparations or change the therapy
„If the pen does not have any of the above numbers, it can continue to be used normally“, otherwise the patients should „Contact the pharmacy to see if the pen can be exchanged for another one from an unaffected batch“, reports the BfArM. If there is no possibility of an exchange, the persons concerned should consult their doctor in order to discuss a change of treatment with him, explains the Federal Institute. However, until a conversation with the doctor has taken place, the patients should not stop their treatment, according to the authority, but only control their blood sugar levels. The company Novo Nordisk has set up a telephone hotline for the affected patients under 06131 / 903-1113. (Fp)