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About the Early Warning System

4 June 2013

The Early Warning System includes current and historical information on safety concerns for medicines and medical devices. These communications are issued as part of a joint project between the TGA and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). While the communication process is the same in both countries, the communications themselves are country-specific and the recommendations may differ because of different legislative requirements, and different availability and/or usage of certain therapeutic products between Australia and New Zealand. You can view New Zealand communications on the Medsafe website.

Therapeutic products provide important benefits for consumers but no therapeutic product is completely risk free. While many risks are identified before the product is used in Australia, some are identified later. The process of identifying these risks and analysing the benefit versus risk profile of a therapeutic product is described in the Therapeutic Product Vigilance section. The Early Warning System is part of TGA's proactive approach to monitoring the safety of medicines and medical devices.

The known risks associated with prescription or pharmacist-only medicines in Australia are outlined in the Product Information (PI) and the Consumer Medicine Information (CMI) documents. The known risks for other types of medicines (including sunscreens, many vitamin, mineral, herbal and homoeopathic products) and medical devices are generally outlined in the PI/instructions for use and/or labelling supplied with the therapeutic product. Your health professional can also provide help and assistance on how to use medicines or medical devices.

There are two types of communications that can be issued as part of the Early Warning System.

1. Monitoring communications

Early communications about potential safety concerns are provided in the monitoring communications section. These concerns have not been fully investigated. The intention of these communications is to highlight potential safety concerns that are identified by the TGA. In addition, the TGA aims to encourage further reporting and research to provide more information on these safety concerns as at this stage, little information is known about the safety concern.

Consumers should NOT stop using a medicine or medical device following a monitoring communication. If you have any concerns with a therapeutic product you are using, please contact your health professional.

Health professionals should not change a patient's treatment as a result of a monitoring communication.

Not all of these concerns will result in the TGA taking an action. This may be because after investigation, the TGA has not found evidence to support a link between the events and the therapeutic product. The TGA may reinvestigate the safety concern if more information is identified at a later date.

2. Alert communications

An alert communication is issued once a safety concern has been investigated. Alerts contain more information on the safety concern and provide advice on actions that may need to be taken by health 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 Australia can be viewed in the publicly accessible and searchable database: System for Australian Recall Actions (SARA).

Additional information on the Early Warning System including the decision criteria used, content of communications, publication and update process of communications can be found at Trans-Tasman Early Warning System: Processes in Australia and New Zealand.

Reporting adverse events to medicines and medical devices

Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.

Summaries of medicine adverse events reported in Australia can be viewed in the Database of Adverse Event Notifications.

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