Revised: 8 August  2024

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
8 August 2024 Monitoring Medicine M2 logo Direct acting oral anticoagulants and potential for patients to experience mood changes (monitoring closes February 2025)
9 July 2024 Monitoring Medicine M2 Logo Update - DPP-4 inhibitors and the possible risk of ileus
13 May 2024 Alert Medicine Promethazine (oral): Do not use in children under 6 years of age due to the risk of psychiatric and central nervous system side effects
8 April 2024 Alert Medicine Do not use NaturaCoco Moisturising Cream or Dok Apo Moisturiser Soothing Cream
8 April 2024 Monitoring Medicine M2 logo Calcium channel blockers and the possible risk of new-onset eczema
4 March 2024 Alert Medicine Recent cases of lead poisoning with Ayurvedic Medicines
15 January 2024 Monitoring Medicine M2 Logo DPP-4 inhibitors and the possible risk of ileus
7 December 2023 Alert Medicine Update - Sodium valproate (Epilim) use in people who can father children: important new safety information
20 November 2023 Monitoring Medicine M2 Logo Update - Interleukin inhibitors and the possible risk of pancreatitis
25 September 2023 Alert Medicine Consent to distribute pholcodine-containing medicines will be revoked on 12 January 2024
4 September 2023 Alert Medicine Processing of adverse event reports received in New Zealand
19 June 2023 Monitoring Medicine M2 Logo Update - Possible risk of seizures with clonidine
30 May 2023 Alert Medicine Sodium valproate (Epilim) use in people who can father children: important new safety information
10 May 2023 Monitoring Medicine M2 Logo Interleukin inhibitors and the possible risk of pancreatitis
26 April 2023 Monitoring Medicine Review of pholcodine-containing medicines – Provide your feedback by 8 May 2023
6 April 2023 Alert Medicine Topiramate use in pregnancy: further restrictions for safety
27 March 2023 Monitoring Medicine M2 Logo Update - Abnormal uterine bleeding and oral anticoagulants (blood thinners)
20 March 2023 Alert Medicine New legislation about medicines that can impair driving
2 March 2023 Monitoring Medicine Reports of pericarditis following mpox vaccination


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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