Revised: 22 November 2022

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
22 November 2022 Monitoring Medicine Goserelin (Teva) 3.6mg and 10.8 mg implants and reports of issues when administering this medicine
8 September 2022 Alert Medicine Myocarditis and pericarditis have been reported with Nuvaxovid (Novavax COVID-19 Vaccine)
5 September 2022 Alert Device Recall of KetoSens Test Strips – batch UJ03PBXNG
29 August 2022 Monitoring Medicine M2 Logo Update – Possible risk of vasculitis with vildagliptin products (Galvus, Galvumet)
25 August 2022 Monitoring Medicine M2 Logo Abnormal uterine bleeding and oral anticoagulants (blood thinners)
13 July 2022 Alert Medicine Medsafe is publishing a warning that the product Nhan Sam Tuyet Lien Truy Phong Hoan should not be consumed
30 June 2022 Alert Medicine Accuretic found to contain nitrosamines
7 June 2022 Alert Device Typographical error in Healgen Rapid COVID-19 Antigen Self-Test (RATs) patient instruction leaflet
8 April 2022 Alert Medicine Reminder: Miracle Mineral Solution has dangerous and potentially life-threatening side effects
22 February 2022 Monitoring Medicine M2 Logo Possible risk of vasculitis with vildagliptin products (Galvus, Galvumet)
20 February 2022 Monitoring Medicine Buccaline tablets: review of the benefits and risks under section 36 of the Medicines Act 1981
19 February 2022 Monitoring Medicine M2 Logo Update - Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions
15 February 2022 Monitoring Medicine Update - Dihydrocodeine: review of risks and benefits
22 December 2021 Alert Medicine Medsafe is issuing a warning not to use Goree Beauty Cream with Lycopene, Goree Day and Night Beauty Cream Oil Free, and Golden Pearl Beauty Cream– statement under section 98 of the Medicines Act 1981
17 December 2021 Alert Medicine Reminder: Comirnaty vaccination (Pfizer COVID-19 vaccine) can cause myocarditis and pericarditis
17 November 2021 Monitoring Medicine COVID-19 vaccination in pregnancy: no safety concerns with Comirnaty (Pfizer COVID-19 vaccine)
17 November 2021 Monitoring Medicine Menstrual disorders and unexpected vaginal bleeding – Comirnaty (Pfizer COVID-19 vaccine)
15 November 2021 Alert Medicine Consent to distribute medicines containing bufexamac was revoked on 9 November 2021


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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