Prexige

Prexige (generic name lumiracoxib) is a prescription drug manufactured by Novartis.

In a 2002 interview, Paulo Costa, the head of Novartis Pharmaceuticals in the US, indicated that he thought the osteoarthritis drug could be a major money-spinner for the company. In its 2006 annual report Novartis stated that "as a result of past investments, Novartis has been able to successfully launch a number of new products in 2006" including Prexige. In 2006 Prexige earned $US47 million for the company, a 488% increase on the previous years sales of $8 million.

In August 2007 the Australian Therapeutic Goods Administration withdrew approval for the marketing of the drug due to a number of cases of serious liver side effects experienced by consumers. Use of the drug caused two deaths and necissitated two consumers to require liver transplants.

English language sites
Global Website: http://www.prexige.com/ Canada: https://www.prexige.ca/form_en.asp United Kingdom: http://www.novartis.co.uk/index.shtml

Other Languages

 * Brazil: http://www.prexige.com/BZ/PT/index.shtml
 * Germany: http://www.prexige.de/de/Prexige/pub/Home/page.html
 * Canada (French): https://www.prexige.ca/form_fr.asp

Therapeutic Goods Administration (Australia) Withdrawal Announcements

 * Therapeutic Goods Administration, "Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib (Prexige)", Media statement, August 11, 2007.
 * Therapeutic Goods Administration, "Urgent advice regarding management of patients taking lumiracoxib (Prexige) advice for health professionals", Safety alert, August 13 2007.
 * Therapeutic Goods Administration, "Medicine recall notice: Lumiracoxib (PREXIGE)", August 10, 2007.

National Prescribing Service (Australia) Announcements

 * National Prescribing Service, "New COX-2: benefit and heart risk to be balanced", August 1, 2006.
 * National Prescribing Service, "Lumiracoxib (Prexige) for osteoarthritis", Medicine update, April 2007.
 * National Prescribing Service, "NPS issues prescribing advice following Lumiracoxib withdrawal", Media Release, August 14, 2007.

Company Links & Announcements

 * "Lumiracoxib", Novartis Clinical Trials Database, accessed August 2007.
 * "Novartis Withdraws Prexige in Australia", Media Release, August 11, 2007.
 * Novartis, "PREXIGE(R) lumiracoxib", Consumer Medicine Information, April 2007.

US FDA Related Links

 * "FDA requests additional data on arthritis and pain drug, lumiracoxib", Media Release, September 23, 2003.
 * Lourdes Villalba, "Briefing package for Lumiracoxib: Preliminary review of GI and CV data from TARGET", U.S. Food and Drug Administration, January 18, 2005.
 * "FDA Discloses Safety Reviews Of Arcoxia, Prexige and Parecoxib", FDAAdvisoryCommittee.com, February 15, 2005.