Bextral

Of the patients treated with BEXTRA Tablets in controlled arthritis trials, 2665 were patients with OA, and 2684 were patients with RA.

More than 4000 patients have received a chronic total daily dose of BEXTRA 10 mg or more. 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.

Bextra (generic name: valdecoxib) , a Cox-2 Inhibitor drug, is in the same drug family as Vioxx, Celebrex and Naproxen. People prescribed Bextra have experienced a higher number of heart attacks, strokes and other cardiovascular problems. Bextra is a COX-2 inhibitor, marketed by Pharmacia Corporation and Pfizer Inc. in the United States. The drug is prescribed for the treatment of osteoarthritis, adult rheumatoid arthritis, and the pain associated with menstrual cramping.

FDA advisory committee hearings held in February 2005 examined whether Celebrex and Bextra offered enough benefits to stay on the market, if they needed stronger warnings and what further research was needed. The advisers met from February 16, 2005 through February 18, 2005 and ultimately voted to keep Bextra on the market. The New York Times reported that 10 of the 32 government drug advisers who voted to keep Bextra and the other COX-2 drugs on the market have consulted for pharmaceutical manufacturers. If these 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn.

MORE DRUG INFO

• Application site disorders: Cellulitis, dermatitis contact
• Cardiovascular: Aggravated hypertension, aneurysm, angina pectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, hypotension
• Central, peripheral nervous system : Cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, tremor, twitching, vertigo
• Endocrine: Goiter
• Female reproductive: Amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, vaginal hemorrhage
• Gastrointestinal: Abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroesophageal reflux, hematemesis, hematochezia, hemorrhoids, hemorrhoids bleeding, hiatal hernia, melena, stomatitis, stool frequency increased, tenesmus, tooth disorder, vomiting
• General: Allergy aggravated, allergic reaction, asthenia, chest pain, chills, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, peripheral pain
• Hearing and vestibular: Ear abnormality, earache, tinnitus
• Heart rate and rhythm: Bradycardia, palpitation, tachycardia
• Hemic: Anemia
• Liver and biliary system: Hepatic function abnormal, hepatitis, ALT increased, AST increased
• Male reproductive: Impotence, prostatic disorder
• Metabolic and nutritional: Alkaline phosphatase increased, BUN increased, CPK increased, creatinine increased, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, LDH increased, thirst increased, weight decrease, weight increase, xerophthalmia
• Musculoskeletal: Arthralgia, fracture accidental, neck stiffness, osteoporosis, synovitis, tendonitis
• Neoplasm: Breast neoplasm, lipoma, malignant ovarian cyst
• Platelets (bleeding or clotting): Ecchymosis, epistaxis, hematoma NOS, thrombocytopenia
• Psychiatric: Anorexia, anxiety, appetite increased, confusion, depression, depression aggravated, insomnia, nervousness, morbid dreaming, somnolence
• Resistance mechanism disorders: Herpes simplex, herpes zoster, infection fungal, infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media
• Respiratory: Abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis, pneumonia, pharyngitis, pleurisy, rhinitis
• Skin and appendages: Acne, alopecia, dermatitis, dermatitis fungal, eczema, photosensitivity allergic reaction, pruritus, rash erythematous, rash maculopapular, rash psoriaform, skin dry, skin hypertrophy, skin ulceration, sweating increased, urticaria
• Special senses: Taste perversion
• Urinary system: Albuminuria, cystitis, dysuria, hematuria, micturition frequency increased, pyuria, urinary incontinence, urinary tract infection
• Vascular: Claudication intermittent, hemangioma acquired, varicose vein
• Vision: Blurred vision, cataract, conjunctival hemorrhage, conjunctivitis, eye pain, keratitis, vision abnormal
• White cell and RES disorders: Eosinophilia, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia Other serious adverse events that were reported rarely (estimated <0.1%) in clinical trials, regardless of causality, in patients taking bextra:
• Autonomic nervous system disorders: Hypertensive encephalopathy, vasospasm
• Cardiovascular: Abnormal ECG, aortic stenosis, atrial fibrillation, carotid stenosis, coronary thrombosis, heart block, heart valve disorders, mitral insufficiency, myocardial infarction, myocardial ischemia, pericarditis, syncope, thrombophlebitis, unstable angina, ventricular fibrillation
• Central, peripheral nervous system: Convulsions
• Endocrine: Hyperparathyroidism
• Female reproductive: Cervical dysplasia
• Gastrointestinal: Appendicitis, colitis with bleeding, dysphagia, esophageal perforation, gastrointestinal bleeding, ileus, intestinal obstruction, peritonitis
• Hemic: Lymphoma-like disorder, pancytopenia
• Liver and biliary system: Cholelithiasis
• Metabolic: Dehydration
• Musculoskeletal: Pathological fracture, osteomyelitis
• Neoplasm: Benign brain neoplasm, bladder carcinoma, carcinoma, gastric carcinoma, prostate carcinoma, pulmonary carcinoma
• Platelets (bleeding or clotting): Embolism, pulmonary embolism, thrombosis
• Psychiatric: Manic reaction, psychosis
• Renal: Acute renal failure
• Resistance mechanism disorders: Sepsis
• Respiratory: Apnea, pleural effusion, pulmonary edema, pulmonary fibrosis, pulmonary infarction, pulmonary hemorrhage, respiratory insufficiency
• Skin: Basal cell carcinoma, malignant melanoma
• Urinary system: Pyelonephritis, renal calculus
• Vision: Retinal detachment
• Postmarketing Eperience
• The following reactions have been identified during postmarketing use of BEXTRA. These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to BEXTRA, or a combination of these factors. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• General: Hy persensitivity reactions (including anaphylactic reactions and angioedema)
• Skin and appendages: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

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