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Safety Information

Revised: 2 November 2015

Early Warning System

The early warning system provides current and historical information on safety concerns for medicines and medical devices (also known as therapeutic products). These warnings 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 process of identifying these risks is described in the sections on safety monitoring of medicines and safety monitoring of devices.  The early warning system is part of Medsafe’s proactive approach to monitoring the safety of medicines and medical devices.

Find information on safety monitoring of medicines

Find information on safety monitoring of medical devices

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.

The early warning system was the result of a joint project between Medsafe and the Australian Therapeutic Goods Administration (TGA). Whilst the communication process is the same in both countries, the communications themselves are country specific and the recommendations may differ.

There are two parts to the Early Warning System.

  1. Monitoring Communications

    Newly identified potential safety concerns are provided in the monitoring communication section. These concerns have not been fully investigated. The intention of these communications is to provide early information when safety concerns are identified.

    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.

    Monitoring communications are issued to encourage further reports to provide more information on these safety concerns. Safety concerns for which Medsafe is actively seeking further reports are included in the medicines monitoring scheme M² logo

    Find information on the Medicines Monitoring scheme M² logo

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

    Find more information on monitoring communication

  2. 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.

    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. A summary of recent recall actions initiated in New Zealand can be viewed in the publicly accessible and searchable database: Medsafe Online Recalls Database (MORD).

    View the Medsafe Online Recall Database

    Find more information on alert communications

How to Report Adverse Events to Medicines and Medical Devices

Medsafe advises you to consult your healthcare professional if you suspect that you are experiencing an adverse event to a medicine or medical device.

Please report all adverse events suspected to be linked to medicines or medical devices.

Summaries of medicine adverse events reported to Medsafe can be viewed in the Suspected Medicine Adverse Reaction Search (SMARS) and the Joint Adverse Event Notification System (JAENS-medicines).

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)

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