Adverse events now online
August 2, 2012
THE Therapeutic Goods
Administration has launched a new
online database covering adverse
medicines events which have been
reported since 1971.
The information includes reports
about prescription medicines as
well as OTC and complementary
products, and currently contains
around 251,000 adverse events
reported by consumers, health
professionals and industry.
Just last year the TGA received
more than 14,000 adverse event
reports.
“This is a great advance in
transparency by Australia’s
medicines regulator,” said
Parliamentary Secretary for Health
and Ageing, Catherine King.
However she urged consumers to
understand that the details on the
database are not necessarily an
indication of 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,” she said.
The database is searchable by
medicine name and covers
commonly reported adverse events
as well as de-identified patient
reports, including information on
other medicines they were taking
at the time of the event and the
reactions they experienced.
The TGA has developed the new
resource together with NZ
regulator Medsafe, as part of the
staged implementation of the
Australia New Zealand Therapeutic
Products Agency.
See tga.gov.au/safety/daen.htm.
MEANWHILE the TGA has
released a new edition of its
Medicines Safety Update, covering
a range of issues including
accidental paracetamol poisoning
which can sometimes occur at
therapeutic doses.
There’s also coverage of new
Product Information for strontium
ranelate (Protos), covering the risks
of venous thromboembolism and
serious skin reactions.
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