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Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods

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In November 2011, the delegate of the Secretary of the Department of Health and Ageing gave notice that the Therapeutic Goods Administration (TGA) intended to remove dextropropoxyphene (brand names Di-Gesic and Doloxene) from the Australian Register of Therapeutic Goods.1

This followed a review of the safety and efficacy of medicines containing dextropropoxyphene. The TGA “determined that the overall risk of serious adverse reactions outweighs any benefits that may be provided by these medicines”.2 The main concern was the risk of sudden death from cardiotoxicity (not shared by other opioid drugs), in the setting of renal impairment, drug interactions and accidental or deliberate overdose.26

Evidence against dextropropoxyphene has been accumulating for over 30 years.3 The drug has been removed from the market by medicine regulators in the United Kingdom (2004), European Union (2009), United States (2010), New Zealand (2010) and elsewhere.2 Over a decade…