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The Food and Drug Administration plans to convene an advisory committee in February 2005 to review cardiovascular safety of all COX-2 inhibitors. "We look forward to a scientific and reasoned evaluation in this appropriate setting," Dr. Feczko said.
Additional Information on Bextra
Bextra is contraindicated in patients who have demonstrated allergic-type reactions to sulfonamides; in patients with known hypersensitivity to valdecoxib; and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs because severe, rarely fatal, anaphylactic-like reactions to NSAIDS are possible in such patients. In rare cases, serious skin reactions can occur. Fatalities due to Stevens- Johnson syndrome and toxic epidermal necrolysis have been reported. If an allergic reaction is suspected or if there are other severe or unusual symptoms while taking Bextra, a patient should call his or her doctor or other healthcare professional immediately.
DISCLOSURE NOTICE: The information contained in this document is as of November 10, 2004. Pfizer assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments.
This document contains forward-looking information. A list and description of risks and uncertainties relating to matters discussed in this document can be found in Company's Annual Report on Form 10-K for fiscal year ended December 31, 2003, and in its periodic reports on Forms 10-Q and 8-K.
(1) White WB, et al. "Effects of Cyclooxygenase-2 Specific Inhibitor Valdecoxib Versus Nonsteroidal Antiinflammatory Agents and Placebo on Cardiovascular Thrombotic Events in Patients with Arthritis." American Journal of Therapeutics. 2004; 11: 244-250. Number 4.
Michael Monheit, Esquire is the managing attorney for Monheit Law, located in Philadelphia, Pennsylvania Monheit Law, P.C. concentrates its practice in the field of plaintiff personal injury cases on a contingency fee basis. They can be found at http://www.monheit.com/Bextra