Revised: 6 September 2021

Safety Information

Medsafe Safety Communications

What are Medsafe safety communications?
Monitoring communications
Alert communications
Medsafe communications issued in the last 12 months
Medsafe communications issued more than 12 months ago
Further information

What are Medsafe safety communications?

These communications are intended to help consumers and healthcare professionals make informed decisions about their use of medicines and medical devices.

Medicines and medical devices provide important benefits for consumers but no product is completely safe. Whilst many risks are identified before the product is used in New Zealand some are identified later.

The known risks associated with medicines in New Zealand are outlined in the consumer medicine information (CMI) and the data sheet. The known risks for medical devices are generally outlined in the product information/user manual. Your healthcare professional can also provide help and assistance on how to use medicines or medical devices. Further information may be found on the product packaging or the company supplying the medicine or medical device may operate a helpline.

There are two types of Medsafe safety communications.

  1. Monitoring communications
  2. Alert communications

Anyone can subscribe to receive Medsafe safety communications.

How do I subscribe to receive Medsafe safety communications?

Monitoring Communications

These communications are intended to provide information to consumers and healthcare professionals about newly identified potential safety concerns.

In some cases, these communications are issued to request further information from users. Safety concerns for medicines for which Medsafe is actively seeking further reports display this symbol:

No actions are generally advised, other than to follow the instructions provided with the medicine or medical device. Consumers should NOT stop using a medicine or medical device following a monitoring communication. Healthcare professionals should not change a patient's treatment because of a monitoring communication.

Not all of these concerns will result in an action. This is because after an investigation, Medsafe may not consider that there is a link between the events and the medicine or medical device. Medsafe may reinvestigate the concern if more information is identified at a later date.

Alert Communications

Alert communications are issued once a review of the safety concern is complete. Alerts contain more information on the safety concern and provide specific advice on actions that may need to be taken by healthcare professionals and consumers.

Even though an alert has been issued it does not necessarily mean that a medicine or medical device is considered to be unsafe.

Safety concerns which identify defective medicines or medical devices supplied in the market may result in a recall action. This can include removal of the product from supply or undertaking corrective action. Recent recall actions initiated in New Zealand are published in the Medsafe Online Recalls Database (MORD).

Search the Medsafe Online Recall Database (MORD)

Medsafe Safety Communications Issued in the last 12 months

 

Date Communication Product Type Topic
6 September 2021 Alert Medicine Risks of importing or prescribing ivermectin for prevention or treatment of COVID-19
12 August 2021 Monitoring Medicine Dihydrocodeine: review of risks and benefits
21 July 2021 Alert Medicine Myocarditis and pericarditis - rare adverse reactions to Comirnaty (Pfizer COVID-19 vaccine)
9 June 2021 Monitoring Medicines M2 Logo Myocarditis – a potential adverse reaction to Comirnaty (Pfizer COVID-19 vaccine)
31 May 2021 Monitoring Medicine M2 Logo Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions
28 April 2021 Alert Medicine Fluad Quad - a newly funded influenza vaccine for people aged 65 years and older
27 April 2021 Monitoring Medicine COVID-19 vaccines and rare cases of blood clots with bleeding: no current risk with Comirnarty (Pfizer/ BioNTech) vaccine
7 April 2021 Monitoring Medicine M2 Logo UPDATE: Possible risk of psoriasis exacerbation with bupropion
23 March 2021 Monitoring Medicine UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
16 March 2021 Alert Medicine UPDATE - Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy
2 March 2021 Alert Device UPDATE - Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results
10 December 2020 Monitoring Medicine M2 Logo UPDATE: Potential interaction between fluoxetine and levothyroxine
10 December 2020 Monitoring Medicine Antiseptic Soothing Cream: review of the benefits and risks requested under section 36 of the Medicines Act 1981
6 November 2020 Alert Medicine UPDATE: Important updates to clozapine data sheets and monitoring during covid-19 pandemic
30 October 2020 Monitoring Medicine UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
23 October 2020 Monitoring Medicine Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
19 October 2020 Monitoring Medicine Technical issue with CareLink Plus database affecting clozapine monitoring
29 September 2020 Monitoring Medicine M2 Logo Possible risk of psoriasis exacerbation with bupropion
15 September 2020 Alert Medicine Medsafe is issuing a warning that Elevacity Elevate Smart Coffee (Version 3) should not be consumed – statement under section 98 of the Medicines Act 1981
3 September 2020 Alert Device Update - Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results
31 May 2020 Monitoring Medicine Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy
23 July 2020 Alert Device Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results
9 June 2020 Alert Medicine Important updates to clozapine data sheets and monitoring during covid-19 pandemic
28 May 2020 Alert Medicine Miracle Mineral Solution – dangerous and potentially life-threatening side effects 
21 May 2020 Monitoring Medicine M² Logo Update - Possible risk of vasculitis with dabigatran (Pradaxa)
21 May 2020 Monitoring Medicine M² Logo Potential interaction between fluoxetine and
levothyroxine
13 May 2020 Monitoring Medicine Potential interaction between fluoxetine and levothyroxine


Medsafe safety communications issued more than 12 months ago

Further Information

Further information on the development of the Medicines Monitoring scheme M2 Logo and Medsafe's safety monitoring processes can be found in the following links.

What is the Medicines Monitoring scheme M2 Logo?

How does Medsafe monitor medicine safety?

How does Medsafe monitor the safety and quality of medical devices?

Medsafe safety communications were initially developed as a joint project with the Australian Therapeutic Goods Administration (TGA) and called the trans-Tasman Early Warning System. Further information on this project can be found in the following links.

Consumer questions and answers on the early warning system

Healthcare professionals questions and answers on the early warning system

Audit of the first 12 months of the early warning system (PDF, 350KB, 14 pages)

Further information on the criteria used by Medsafe to decide when to publish a monitoring communication (PDF 224KB, 9 pages)

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