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Number of valid reports in adverse reactions database reaches 250,000

4 April 2012

The number of valid reports entered into the internal TGA database of adverse reactions to medicines reached 250,000 in March 2012.

The TGA would like to thank all report contributors. Reports by consumers and health professionals are voluntary, and the TGA would like to encourage all consumers and health professionals to submit reports of suspected reactions to medicines to the TGA. Such information is vital to TGA efforts to promote the ongoing safe use of medicines in the community.

Reports submitted by consumers, health professionals and industry are entered into the internal database. This database is then used to detect whether there might be a problem with a particular medicine (signal detection). This problem might be entirely unknown, or might be a problem that was originally thought of as rare, but actually turns out to be more frequent. Once a potential problem with a medicine is identified, further investigation is conducted by the TGA to determine whether some kind of regulatory action is required.

The first report of an adverse reaction to a medicine was received by the Australian regulator in the mid-1960s, and the first case entered into the current database was on 17 November 1971. The number of cases has now reached 250,000. Help us to make this number larger by submitting your reports to the TGA.