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About monitoring communications

4 June 2013

The TGA emphasises that patients should NOT stop using a medicine or medical device subject to a monitoring communication. If you have any concerns with a therapeutic product you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Therapeutic products provide important benefits for consumers but no therapeutic product is completely risk free.

This section contains communications issued by the TGA for safety concerns with medicines and medical devices shortly after they have been identified. These communications highlight potential safety concerns which have not been fully investigated. The appearance of a safety concern in this section does not mean that the TGA has concluded that the medicine or medical device causes an adverse event.

Consumers are advised to use products according to the instructions provided with the medicine or medical device. For prescription and pharmacist-only medicines, these are outlined in the Consumer Medicines Information (CMI), which is either included in the medicine pack or available in a separate leaflet from the pharmacist. You can also look up CMI information on the TGA website's CMI search facility. 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 product information/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.

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

If you or someone you know has experienced one of these safety concerns please submit a report. This helps the TGA to investigate these safety concerns and decide if any action needs to be taken.

It is likely that some safety concerns that resulted in monitoring communications being issued will not result in any action being taken and these communications will be updated accordingly. If the TGA's review of the safety concern concludes that there is a demonstrated link with a medicine or medical device, an alert may be issued. The TGA will take appropriate action to improve the safe use of this medicine or medical device, where required.

All monitoring communications issued will have a subsequent communication advising of the outcome.