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

Article type: Research Article

Authors: Whitstock, Margaret T.^; | Eckermann, Elizabeth J. | Marjoribanks, Timothy K. | Pearce, Christopher M.

Affiliations: Deakin University, Waurn Ponds Campus, Geelong, VIC, Australia | School of Social and Political Sciences, The University of Melbourne, Melbourne, VIC, Australia | Melbourne East General Practice Network, Surrey Hills, VIC, Australia

Note: [] Address for correspondence: M.T. Whitstock, Melbourne University, P.O. Box 4264, Melbourne, VIC 3052, Australia. Tel.: +61 3 9376 0138; Fax: c/o +61 3 9639 7377; E-mails: whitstock@iinet.net.au; mtwh@deakin.edu.au.

Abstract: 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as biochemically selective in inhibiting the COX-2 isoform as celecoxib, and twice as selective as rofecoxib, already withdrawn for safety reasons.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over patient safety, and lumiracoxib 200 mg remained available via the PBS until 10 August 2007, when it was withdrawn for safety reasons following cases of hepatic morbidity and mortality.

Keywords: Lumiracoxib, Prexige, COX-2 inhibitors, coxibs, NSAIDs, pharmaceutical regulatory policy (Australia)

DOI: 10.3233/JRS-2008-0439

Journal: International Journal of Risk and Safety in Medicine, vol. 20, no. 3, pp. 161-167, 2008