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In Australia, it is mandatory for pharmaceutical companies to report all serious adverse events suspected of being related to their drugs, but reporting by health professionals has always been voluntary.… Click to show full abstract
In Australia, it is mandatory for pharmaceutical companies to report all serious adverse events suspected of being related to their drugs, but reporting by health professionals has always been voluntary. Without robust reporting mechanisms supporting the detection of safety signals, rare adverse drug events may remain undetected for years, exposing patients to unanticipated risks. Examples of high-profile drug withdrawals include lumiracoxib (associated with severe hepatotoxicity), which only occurred after thousands of patients in Australia had been exposed.6
Journal Title: Australian Prescriber
Year Published: 2021
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