On-Line TGA Database Provides Information on Adverse Reactions to Medicines

“From today consumers, health professionals and industry can access online information about adverse events to medicines that have been reported to the Therapeutic Goods Administration (TGA) since 1971. Announcing the new online resource the Parliamentary Secretary for Health and Ageing, Catherine King, said the Database of Adverse Event Notifications, includes adverse event reports about prescription medicines, over-the-counter medicines sold in pharmacies and supermarkets, as well as complementary medicines such as vitamins and herbal remedies. ‘The Database currently contains around 251,000 reports of adverse events,’ Ms King said... ‘This is a great advance in transparency by Australia's medicines regulator, and I expect the public and industry will welcome this information resource which will improve reporting of adverse events.’ Ms King said it is important for consumers to understand that the information about adverse events to a medicine is not necessarily an indication of that medicine’s effectiveness. ‘The data should not influence a person's decision to stop taking a medicine – it is simply meant to give consumers additional information that they can discuss with their healthcare professional if they have any concerns.’ Ms King said that, for the first time, the public can search the Database by the name of a medicine to find out: [1] commonly reported adverse events to a particular medicine; and [2] de-identified reports about each patient, including information on other medicines they were taking and the reaction/s they experienced. ‘This is a great new resource provided by the TGA to make the work of the regulator more transparent and accessible to the community and to industry,’ she said. Currently, there are 28,586 medicines approved by the TGA in Australia. The TGA relies on the public, healthcare professionals, manufacturers and suppliers to report problems with medicines or medical devices – this allows it to identify and respond to safety problems. Please visit the TGA website for information on how to report a problem. The TGA and the New Zealand regulator, Medsafe, have worked together on the development of two publicly accessible databases that provide information on adverse events reported to each organisation. This project is part of the staged implementation of the move to becoming the Australia New Zealand Therapeutic Products Agency.”