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Bextra (Valdecoxib) - Summary

 

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Serious Skin Reactions

  • Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving BEXTRA. Some of these reactions have resulted in death.
  • Patients appear to be at higher risk for these events within the first 2 weeks of treatment, but these may occur at any time during treatment.
  • The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other COX-2 agents.
  • BEXTRA should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

(See WARNINGS – Serious Skin Reactions)

 

BEXTRA SUMMARY

BEXTRA®
valdecoxib tablets

Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID).

BEXTRA Tablets are indicated:

  • For relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis.
  • For the treatment of primary dysmenorrhea.

BEXTRA NEWS HIGHLIGHTS

Published Studies Related to Bextra (Valdecoxib)

Intravenous parecoxib rapidly leads to COX-2 inhibitory concentration of valdecoxib in the central nervous system. [2008.03]

Utility and sensitivity of the sore throat pain model: results of a randomized controlled trial on the COX-2 selective inhibitor valdecoxib. [2007.07]

Efficacy and tolerability of valdecoxib in treating the signs and symptoms of severe rheumatoid arthritis: a 12-week, multicenter, randomized, double-blind, placebo-controlled study. [2007.06]

Utility and Sensitivity of the Sore Throat Pain Model: Results of a Randomized Controlled Trial on the COX-2 Selective Inhibitor Valdecoxib. [2007.05.24]

Valdecoxib is as efficacious as diclofenac in the treatment of acute low back pain. [2007.03]

more>>

Clinical Trials Related to Bextra (Valdecoxib)

Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction [Completed]

A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery [Completed]

A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat [Completed]

Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery [Completed]

A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan) [Completed]

more>>

Page last updated: 2008-03-26

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