Valdecoxib
Clinical data | |
---|---|
Trade names | Bextra |
Pregnancy category |
|
Routes of administration | Oral |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | 83% |
Protein binding | 98% |
Metabolism | Hepatic (CYP3A4 and 2C9 involved) |
Elimination half-life | 8 to 11 hours |
Excretion | Renal |
Identifiers | |
| |
JSmol) | |
| |
| |
(what is this?) (verify) |
Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995.[2]
Valdecoxib was manufactured and marketed under the brand name Bextra by
In 2009, Bextra was at the center of the "largest health-care fraud settlement and the largest criminal fine of any kind ever."
A water-soluble and injectable prodrug of valdecoxib, parecoxib, is marketed in the European Union under the tradename Dynastat.
Uses until 2005
In the United States, the FDA approved valdecoxib for the treatment of osteoarthritis, adult rheumatoid arthritis, and primary dysmenorrhea.[8]
Valdecoxib was also used
Side effects and withdrawal from market
On April 7, 2005, Pfizer withdrew Bextra from the U.S. market on recommendation by the FDA, citing an increased risk of
Pfizer first acknowledged cardiovascular risks associated with Bextra in October 2004. The
In a large study published in
2009 settlement for off-label uses promotions
This section may lend create a more balanced presentation. Discuss and resolve this issue before removing this message. (December 2012) |
On September 2, 2009, the
The remaining $1 billion of the fine were paid to resolve allegations under the civil
Analytical methods
Several HPLC-UV methods[18] have been reported for valdecoxib estimation in biological samples like human urine.[19][20] Valdecoxib has analytical methods for bioequivalence studies,[21][22] metabolite determination,[23][24][19] estimation of formulation,[25] and an HPTLC method for simultaneous estimation in tablet dosage form.[26]
See also
References
- ^ Anvisa (2023-03-31). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 2023-04-04). Archived from the original on 2023-08-03. Retrieved 2023-08-16.
- ISBN 9783527607495.
- ^ a b "Pfizer fined $2.3B in record fraud settlement Pharma giant illegally promoted product: Justice Department says, in largest health care fraud settlement in history". Washington: CNN. 2 September 2009. Retrieved 28 December 2015.
- ^ a b Gardiner H (2 September 2009). "Pfizer Pays $2.3 Billion to Settle Marketing Case". New York Times. Retrieved 28 December 2015.
- ^ "Valdecoxib. U.S. FDA Drug Approval". Thomson Micromedex. Retrieved June 8, 2007.
- ^ a b "Information for Healthcare Professionals: Valdecoxib (marketed as Bextra)". U.S. Food and Drug Administration. 2005. Retrieved 28 December 2015.
- ^ Elkind P, Reingold J (28 July 2011). "Inside Pfizer's palace coup". Fortune. Retrieved 28 December 2015.
- ^ a b "Pfizer to pay $2.3 billion to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks". Stop Medicare Fraud, US Dept of Health & Human Svc, and of Justice. Archived from the original on 2012-08-30. Retrieved 2012-07-04.
- PMID 16968832. Archived from the originalon 2020-11-05. Retrieved 2006-09-17.
- ^ "Pfizer agrees record fraud fine", BBC, 2009-09-02
- ^ "Pharmacia & Upjohn Company Inc Pleads Guilty to Fraudulent Marketing of Bextra". The United States Attorney's Office, District of Massachusetts. 15 September 2009. Archived from the original on 7 December 2009. Retrieved 2009-10-16.
- ^ "Ex-Pfizer Manager Found Guilty of Obstruction". The United States Department of Justice - United States Attorney's Office - District of Massachusetts. 17 March 2009. Archived from the original on 1 June 2009. Retrieved 16 October 2009.
- ^ Edwards J (2009-06-26). "Pfizer's Off-Label Bextra Team Was Called "The Highlanders" - CBS News". Industry.bnet.com. Archived from the original on June 29, 2009. Retrieved 2019-06-06.
- ^ "Pharmaceutical Company Manager Sentenced for Off-Label Marketing". The United States Department of Justice - United States Attorney's Office - District of Massachusetts. 18 June 2009. Archived from the original on 1 September 2009. Retrieved 16 October 2009.
- ^ "Justice Department Announces Largest Health Care Fraud Settlement in Its History: Pfizer to Pay $2.3 Billion for Fraudulent Marketing". Federal Bureau of Investigation - Press Release. 2 September 2009. Archived from the original on 9 September 2010. Retrieved 28 July 2016.
- ^ "Pfizer settlement and Bextra whistleblower case: News stories and court documents". Whistleblower News | Articles, Blogs, & Insights. Phillips & Cohen LLP. Archived from the original on 5 February 2011. Retrieved 6 June 2019.
- ^ "Bextra whistleblower case leads to record-setting Pfizer settlement". Whistleblower news. Phillips & Cohen LLP. Archived from the original on 29 December 2010. Retrieved 2019-06-06.
- ISBN 978-3-8443-2869-1.
- ^ PMID 12535845.
- S2CID 95275785.
- ^ Sahu PK, Sankar KR, Annapurna MM (2011). "Determination of Valdecoxib in Human Plasma Using Reverse Phase HPLC" (PDF). Journal of Chemistry. 8 (2): 875–881.
- ^ Mandal U, Jayakumar M, Ganesan M, Nandi S, Pal TK, Chakraborty MK, Roy Chowdhary A, Chattoraj TK (2004). "[title]". Indian Drugs. 41: 59.
- PMID 12946532.
- PMID 15473012.
- ^ Sutariya VB, Rajashree M, Sankalia MG, Priti P (2004). "Spectrophotometric Estimation Of Valdecoxib In Pure Form And Tablets". Indian Journal of Pharmaceutical Sciences. 66 (3): 360–362.
- .