Pharmaceutical ecomonics and politics vs. patient safety : Lumiracoxib in Australia

Whitstock, Margaret T., Eckermann, Elizabeth J., Majoribanks, Tomothy K. and Pearce, Christopher M. 2008, Pharmaceutical ecomonics and politics vs. patient safety : Lumiracoxib in Australia, The international journal of risk and safety in medicine, vol. 20, no. 3, pp. 161-167.

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Title Pharmaceutical ecomonics and politics vs. patient safety : Lumiracoxib in Australia
Author(s) Whitstock, Margaret T.
Eckermann, Elizabeth J.ORCID iD for Eckermann, Elizabeth J.
Majoribanks, Tomothy K.
Pearce, Christopher M.
Journal name The international journal of risk and safety in medicine
Volume number 20
Issue number 3
Start page 161
End page 167
Total pages 7
Publisher Elsevier
Place of publication Amsterdam, The Netherlands
Publication date 2008
ISSN 0924-6479
Keyword(s) COX-2 inhibitors
pharmaceutical regulatory policy (Australia)
Summary Lumiracoxib (Prexige©) 200 mg was listed in Australia’s Pharmaceutical Benefits Scheme (PBS) schedules on 01 August 2006. The listing was intended as a cost-minimisation strategy, as lumiracoxib 200 mg was deemed equivalent in therapeutic effect to celecoxib (Celebrex©) 200 mg, and was available at a lower cost. By the time of listing on the PBS, a safety re-evaluation of the recommended daily dose of lumiracoxib was being considered in other national regulatory jurisdictions. Within 3 months of listing, the manufacturer revised the recommended dosage to half that of the PBS-listed dosage. However, the PBS listing was neither revoked nor modified. At the time of listing on the PBS, lumiracoxib was known to be 17 times as biochemically selective in inhibiting the COX-2 isoform as celecoxib, and twice as selective as rofecoxib, already withdrawn for safety reasons. Safety concerns had already been raised about adverse hepatic outcomes on daily doses of lumiracoxib 200 mg. Communication of information about the risk potential of lumiracoxib was inadequate. Economic and political considerations were prioritised over patient safety, and lumiracoxib 200 mg remained available via the PBS until 10 August 2007, when it was withdrawn for safety reasons following cases of hepatic morbidity and mortality.
Language eng
Field of Research 111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 929999 Health not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
HERDC collection year 2008
Copyright notice ©2008, IOS Press and the authors
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