Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic properties in animal models.
Vision : Retinal detachment.
Autonomic nervous system disorders : Hypertensive encephalopathy, vasospasm.
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:.
Of the patients treated with BEXTRA Tablets in controlled arthritis trials, 2665 were patients with OA, and 2684 were patients with RA. More than 2800 patients have received BEXTRA 10 mg/day, or more, for at least 6 months and 988 of these have received BEXTRA for at least 1 year.
Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving Bextra. Bextra Tablets for oral administration contain either 10 mg or 20 mg of valdecoxib. The absolute bioavailability of.
The efficacy and clinical utility of Bextra Tablets have been demonstrated in osteoarthritis (OA), rheumatoid arthritis (RA) and in the treatment of primary dysmenorrhea.
Bextra has not been investigated in pediatric patients below 18 years of age.
The absolute bioavailability of valdecoxib is 83% following oral administration of Bextra compared to intravenous infusion of valdecoxib. Valdecoxib achieves maximal plasma concentrations in approximay 3 hours.
In addition to routine adverse event reporting, pre-specified adverse events of interest were adjudicated according to pre-specified definitions by an independent committee who were blinded to treatment assignment.
I warned about Bextra many other times: in debate with the FDA's top drug expert, Dr. Robert Temple, at the large conference of the Drug Information Association.
1337 Camino Del Mar Suite C Del Mar, CA 92014 Phone: 858.345.1760 858.509.8944 Dear Pfizer :. Medication side effects are the #4 leading cause of death in the U.S. This website is dedicated to providing information to help you and your doctor make informed, inligent choices about medications and natural alternatives to maximize the benefits and minimize the risks of treatment. Jay S. Cohen M.D. Cohen M.D. Jay S. Note: This website is free of drug company or government influence. annually (JAMA 1998).
The popular arthritis drug Bextra is to be pulled from the U.S. market under a decision issued by the FDA.
Along with stricter warnings, patients receiving Celebrex or other prescription anti-inflammatory drugs will now also receive medication guides outlining the risks and benefits of the drugs, Galson says. The additional warnings will begin appearing with the drugs within a few weeks, he says.
FDA officials say they asked Pfizer -- the drug's maker -- to remove it from U.S. pharmacies because its risks of heart, stomach, and skin problems clearly outweighed its benefits.
"The studies were long-term studies with older folks," he says.
Bextra was used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. It was withdrawn from the U.S. market in.
Symptoms of a Bextra overdose include drowsiness, nausea, vomiting, and stomach pain.
Bextra was withdrawn from the U.S. market in 2005.
Bextra may also be used for purposes other than those listed in this medication guide.
fluconazole (Diflucan) or ketoconazole (Nizoral).
CSA Schedule N Not a controlled drug.
You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.