"The US Food and Drug Administration's (FDA's) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted yesterday to recommend premarket approval of the Cartiva Synthetic Cartilage Implant for use in pati"...
(Generic versions may still be available.)
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 dis continued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
(See WARNINGS – Serious Skin Reactions)
Valdecoxib is chemically designated as 4-(5-methyl-3-phenyl-4-isoxazolyl) benzenesulfonamide and is a diaryl substituted isoxazole. It has the following chemical structure:
The empirical formula for valdecoxib is C16H14N2O3S, and the molecular weight is 314.36. Valdecoxib is a white crystalline powder that is relatively insoluble in water (10 μg/mL) at 25°C and pH 7.0, soluble in methanol and ethanol, and freely soluble in organic solvents and alkaline (pH=12) aqueous solutions.
BEXTRA Tablets for oral administration contain either 10 mg or 20 mg of valdecoxib. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.
Last reviewed on RxList: 8/11/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Bextra Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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