Lumiracoxib
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Trade names | Prexige |
AHFS/Drugs.com | International Drug Names |
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Routes of administration | Oral |
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Elimination half-life | 5-8 hours[1] |
Excretion | Urine (54%) and faeces (43%)[1] |
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Lumiracoxib is a
Its structure is different from that of other COX-2 inhibitors, such as
It was patented in 1997 and approved for medical use in 2003.[3] It was manufactured by Novartis and is still sold in few countries, including Mexico, Ecuador and the Dominican Republic, under the trade name Prexige.[1] Lumiracoxib has been withdrawn from the market in several countries, mostly due to its potential for causing liver failure (sometimes requiring liver transplantation). It has never been approved for use in the United States.[1]
History
The TARGET study (Therapeutic Arthritis Research and Gastrointestinal Event Trial) was conducted with more than 18,000 patients to test its gastrointestinal and cardiovascular safety against naproxen and ibuprofen and also study its efficacy against these two NSAIDs.
In November 2006, Prexige received marketing approval for all European Union countries through a common procedure called MRP. However, in August 2007, Prexige was withdrawn from the market in Australia following 8 serious liver adverse events, including 2 deaths and 2 liver transplants.[4] On September 27, 2007, the US Food and Drug Administration issued a not approvable letter for lumiracoxib, requiring additional safety data.[5] Canada withdrew Prexige (approved at 100 mg dose only) in October 2007.[6] Several European Union countries followed suit in November 2007.[7]
The FDA rejected Prexige as a trade name for lumiracoxib in 2003. Prexede was suggested as an alternative, but the FDA Division of Medication Errors and Technical Support (DMETS) subsequently recommended against it as well.[8]
Withdrawal from market
On August 11, 2007, Australia's Therapeutic Goods Administration (TGA, the national agency responsible for regulation of pharmaceuticals) cancelled the registration of lumiracoxib in Australia due to concerns that it may cause liver failure.[9]
According to the TGA's Principal Medical Adviser, Dr Rohan Hammett, as of 10 August 2007 the TGA had received 8 reports of serious adverse liver reactions to the drug, including two deaths and two liver transplants.
"The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug," Dr Hammett said.
"The TGA has taken this advice to cancel the registration of Lumiracoxib in order to prevent further cases of severe liver damage.
"It seems that the longer people are on the medicine, the greater the chance of liver injury. The TGA is, therefore, advising people to stop taking the Lumiracoxib immediately and to discuss alternative treatments with their doctor," Dr Hammett said.[10]
New Zealand has followed suit with Australia in recalling Prexige.[11]
On October 3, 2007, Health Canada requested sales of Prexige to stop. Novartis has agreed to the request and has taken steps to do so.[12] On December 13, 2007, the European Medicines Agency recommended the withdrawal for Prexige from all EU markets.[13]
On January 17, 2008, the
On July 22, 2008, The
On November 12, 2008, INVIMA, the Colombian National Institute for Food and Drug Surveillance ordered the withdrawal of all presentations of lumiracoxib (Prexige), due to the international reports on hepatotoxicity.
References
- ^ S2CID 24063728.
- PMID 14965322.
- ISBN 9783527607495.
- ^ "Urgent medicine recall - Lumiracoxib (PREXIGE)". Therapeutic Goods Administration. Archived from the original on 2007-08-27. Retrieved 2007-08-11.
- ^ "Prexige® receives "not approvable" letter in the US despite being one of the most studied COX-2 inhibitors" (PDF). Novartis.
- ^ "Withdrawal of Market Authorization for Prexige". Health Canada. November 2021.
- ^ "United Kingdom and Germany suspend marketing and sale of Prexige® pending outcome of European regulatory review". Novartis AG. Archived from the original on 2009-09-05. Retrieved 2008-07-02.
- ^ "NDA 21-521/ind 58,495 Prexige (COX189, lumiracoxib 100 mgs tablets)" (PDF). Food and Drug Administration. Archived from the original (PDF) on 2017-05-04. Retrieved 2019-12-16.
- ^ "Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib". Therapeutic Goods Administration. 11 August 2007. Archived from the original on 2009-06-03. Retrieved 11 August 2007.
- ^ "Media statement - Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib (Prexige)". Therapeutic Goods Administration. Archived from the original on 2009-06-03. Retrieved 2007-08-10.
- ^ "NZ regulators ban arthritis drug". The New Zealand Herald. 21 August 2007. Archived from the original on 29 September 2007. Retrieved 12 September 2011.
- ^ "Important Safety Information on Prexige (lumiracoxib)" (PDF). www.novartis.ca. Archived from the original (PDF) on 9 October 2007. Retrieved 25 January 2022.
- ^ "European Medicines Agency recommends withdrawal of the marketing authorisations for lumiracoxib-containing medicines" (PDF). Press release. 13 December 2007. Archived from the original (PDF) on 11 September 2008.
- ^ "DOH recalls lumiracoxib, sets two-week deadline". Abs-Cbn Interactive.
- Folha de S. Paulo(in Portuguese). July 22, 2008. Retrieved 2008-07-22.
- Anvisa. July 22, 2008. Archived from the originalon July 26, 2008. Retrieved 2008-07-22.
- ^ "Anvisa suspende venda e uso de 2 antiinflamatórios" [Anvisa suspends sale and use of 2 anti-inflammatories] (in Portuguese). Terra. October 3, 2008. Retrieved 2008-10-03.
External links
- Prexige
- Forbes
- FDA request more information September 23, 2003
- NPS RADAR
- FDA - Background Document for Lumiracoxib 1/13/2005
- "NZ regulators ban arthritis drug". The New Zealand Herald. 21 August 2007. Archived from the original on 2007-09-29.