Published: 23 October 2020
Revised: 23 March 2021
Safety Information
Monitoring
Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
Update Information
23 March 2021
Monitoring finished on 19 March 2021
Since early January 2021 no further reports of lack of efficacy have been reported for NovoRapid Penfill (insulin aspart 3 mL cartridge). A full quality review of multiple batches was undertaken by the New Zealand sponsor and no quality issues were identified. Independent testing, including testing of a complaint sample, was also conducted by Medsafe which was consistent with the sponsor’s findings.
Medsafe will continue to monitor this issue through routine pharmacovigilance.
Update Information
30 October 2020
This information refers to batch number KR72M95.
There continues to be no indication that this batch is faulty or that it should be recalled.
Investigations into this matter are ongoing.
Medsafe notes that this batch has been in widespread use in New Zealand and was first supplied into the distribution chain in May this year. Prior to 21 October 2020, there had been no unusual increase in reports about concerns with the batch.
Samples of batch KR72M95 that weren’t distributed have been tested and shown to meet specifications. A complaint sample will also be tested. Information received on the manufacture and transport of the batch has not given Medsafe cause for concern.
Novo Nordisk can be contacted at: NovoCare® Customer Care Centre 0800 733 737 (New Zealand) or AUNRCCC@novonordisk.com
Original Information
23 October 2020
Medsafe has been informed by members of the public regarding patients (children and adults) having difficulty managing their blood sugar levels while using NovoRapid Penfill (insulin aspart 3 mL cartridge) with the batch number KR72M95. This batch was distributed between May and September this year, and the first complaint for this batch was received on 21 October 2020.
Medsafe is working with the company to urgently investigate the quality of the NovoRapid Penfill product, batch number KR72M95. The company’s preliminary investigation has not found any evidence to indicate that there is a product quality issue.
Medsafe will provide further advice when we have more information.
Products affected
Additional information
Regulator actions
Reporting
Products affected
| Product name | Batch | Company |
|---|---|---|
| NovoRapid Penfill (insulin aspart 3 mL cartridge) | KR72M95 | Novo Nordisk |
Additional information
NovoRapid is a rapid-acting insulin product used to treat diabetes mellitus in adults and children. NovoRapid has a faster onset and a shorter duration of action than soluble human insulin.
The daily insulin requirement may change with differences in physical activity, changes in diet, or during concomitant illness.
As with all insulins, glucose monitoring should be intensified for elderly patients and patients with hepatic or renal impairment, and the dosage adjusted on an individual basis.
Medsafe is working with the company to investigate the concerns raised by members of the public. Medsafe notes that a similar issue occurred in 2017 and a comprehensive investigation was conducted. The investigation included a review of batch documents and testing of complaint and retention samples by an independent laboratory. The conclusion of the review was that there was no quality issue and no action was taken.
In 2017 it was noted that high and low blood sugar are by far the most frequently reported adverse events for all insulin products. Diabetes, being a complex disease, means that fluctuations in blood sugar levels and subsequent change in patients' insulin requirements can occur for a variety of reasons.
If any patients using NovoRapid who have concerns or questions about their treatment and control of blood sugar levels should also talk to their healthcare professional for advice.
More information on this medicine and known side effects can be found in the consumer medicine information (CMI) and data sheet.
Search for consumer medicine information and data sheets
Medsafe advises patients not to stop using their medicine and to continue to monitor their blood sugar levels as normal.
Regulator actions
Medsafe is currently working with the company to investigate this issue. At this stage there is no indication that this product should be recalled.
Reporting
Medsafe encourages healthcare professional and patients who have concerns about the product and would like to provide us with information to email us at: recalls@health.govt.nz
