On April 7, the Food and Drug Administration requested that Pfizer suspend sales of BEXTRA. The request is based on safety information of Cox II Bextra's cardiovascular, gastrointestinal and skin rash risks.
In understanding the failure of Pfizer to act in the best manner, readers should consult the following articles cited by Jay S. Cohen, M.D., Associate Professor (voluntary), Departments of Family and Preventive Medicine and of Psychiatry
University of California, San Diego:
References:
1. Bextra advertisement. Pfizer Inc. 2004.
2. American Medical Association. AMA Drug Evaluations, Annual 1993. Chicago: American Medical Association, 1993.
3. Clark, WG, Brater, DC, Johnson, AR. Goth's Medical Pharmacology. 12th Edition. St. Louis: The C.V. Mosby Company, 1988.
4. Kivitz, A, Eisen, G, Zhao, WW, Bevirt, T, Recker, DP. Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis. Journal of Family Practice 2002;51(6):530-7.
5. Makarowski, W, Zhao, WW, Bevirt, T, Recker, DP. Efficacy and safety of the COX-2 specific inhibitor valdecoxib in the management of osteoarthritis of the hip: a randomized, double-blind, placebo-controlled comparison with naproxen. Osteoarthritis & Cartilage 2002;10(4):290-6.
6. Ormrod, D, Wellington, K, Wagstaff, AJ. Valdecoxib. Drugs 2002;62(14):2059-71.
7. Bensen WG, Fiechtner JJ, McMillen JI, et al. Treatment of osteoarthritis with celecoxib: a randomized controlled trial. Mayo Clinic Proceedings 1999;74(11):1095?]105.
8. Hubbard, R, Geis, GS, Woods, E, Yu, S, ZHao, W. Efficacy, tolerability, and safety of celecoxib, a specific Cox-2 inhibitor, in osteoarthritis. Arthritis and Rheumatism 1998;41(9 suppl):S196[abstract].
