Rofekoksib

**Rofekoksib** je nesteroidni antiinflamatorni lek (NSAID) koji je povučen sa tržišta iz bezbednostnih razloga. Njega je razvila kompanija Merk (Merck & Co.) za lečenje osteoartritisa, stanja akutnog bola i dismenoreja. Rofekoksib je FDA odobrila 20. maja 1999. On je bio u prodaji pod imenima *Vioxx*, *Ceoxx*, i *Ceeoxx*.

Rofekoksib je postao široko prihvaćen među lekarima koji su tretirali pacijente sa artritisom i drugim oboljenjima koja izazivaju hronični ili akutni bol. Svojevremeno je širom sveta ovaj lek je koristilo oko 80 miliona ljudi.

Merk je 30. septembra 2004 povukao rofekoksib sa tržišta usled zabrinutosti zbog povećanog rizika od srčanog udara vezanog za dugotrajnu upotrebu visokih doza leka. Do povlačenja je došlo nakon obelodanjivanja da informacije o rizicima nisu bile objavljene više od pet godina. To je uzrokovalo između 88,000 i 140,000 slučajeva ozbiljnih oboljenja srca. Rofekoksib je bio jedan od najšire korištenih lekova ikad povučenih sa tržišta. U toku godine pre povlačenja, Merkov prihod od prodaje Vajoksa je bio US$2.5 milijarde.

Rofekoksib je bio dostupan na recept, u obliku tableta i kao oralna suspenzija. U obliku injekcija je prodavan za bolničku upotrebu.

## Reference

## Literatura

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* FDA (2005). "Summary minutes for the February 16, 17 and 18, 2005, Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee." Published on the internet, March 2005. Link
* Fitzgerald GA, Coxibs and Cardiovascular Disease, *N Engl J Med* 2004;**351**(17): 1709&ndash;1711. .
* Grassley CE (15 Oct 2004). *[http://finance.senate.gov/press/Gpress/2004/prg101504.pdf Grassley questions Merck about communication with the FDA on Vioxx.] * Press Release.
* Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M (2004). Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. *Lancet* (published online; see also Merck response below)
* Karha J and Topol EJ. The sad story of Vioxx, and what we should learn from it  *Cleve Clin J Med* 2004; **71**(12):933-939. 
* Michaels, D. (June 2005) DOUBT Is Their Product, *Scientific American,* 292 (6).
* Merck & Co., (5 Nov 2004). *[http://www.merck.com/statement_2004_1105/lancet.pdf Response to Article by Juni et al. Published in The Lancet on Nov. 5.] * Press Release.
* Merck & Co (30 Sep 2004) Merck Announces Voluntary Worldwide Withdrawal of VIOXX. Press release http://www.vioxx.com/vioxx/documents/english/vioxx_press_release.pdf.
* D. M. Mukherjee, S. E. Nissen, and E. J. Topol, “Risk of Cardiovascular Events Associated with Selective COX-2 Inhibitors,” Journal of the American Medical Association 186 (2001): 954–959.
* Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, *et al.* Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. *N Engl J Med* 2005;**352**(11):1081-91. 
* Okie, S (2005) "Raising the safety bar--the FDA's coxib meeting." *N Engl J Med.* 2005 Mar 31;352(13):1283-5. .
* Leleti Rajender Reddy, Corey EJ. Facile air oxidation of the conjugate base of rofecoxib (Vioxx), a possible contributor to chronic human toxicity *Tetrahedron Lett* 2005, **46**: 927. http://dx.doi.org/doi:10.1016/j.tetlet.2004.12.055
* Swan SK *et al.*, Effect of Cyclooxygenase-2 Inhibition on Renal Function in Elderly Persons Receiving a Low-Salt Diet. Annals of Int Med 2000; 133:1–9
* Targum, SL. (1 Feb. 2001) Review of cardiovascular safety database. *FDA memorandum.* http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b2_06_cardio.pdf
* Wolfe, MM et al., Gastrointestinal Toxicity of Nonsteroidal Anti-anflamattory Drugs, New England Journal of Medicine. 1999; 340; 1888-98.

## Vanjske veze
* Reakcija nakon povlačenja leka
* Sudski postupak