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Of the patients treated with BEXTRA (valdecoxib) 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 (valdecoxib) 10 mg or more. More than 2800 patients have received BEXTRA (valdecoxib) 10 mg/day, or more, for at least 6 months and 988 of these have received BEXTRA (valdecoxib) for at least 1 year.

Osteoarthritis and Rheumatoid Arthritis

Table 4 lists all adverse events, regardless of causality, that occurred in ≥2.0% of patients receiving BEXTRA (valdecoxib) 10 and 20 mg/day in studies of three months or longer from 7 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

Table 4 Adverse Events with Incidence 2.0% in Valdecoxib Treatment Groups: Controlled Arthritis Trials of Three Months or Longer

 

(Total Daily Dose)

   

Valdecoxib

Diclofenac

Ibuprofen

Naproxen

Adverse Event

Placebo

10 mg

20 mg

150 mg

2400 mg

1000 mg

Number Treated

973

1214

1358

711

207

766

Autonomic Nervous System Disorders

Hypertension

0.6

1.6

2.1

2.5

2.4

1.7

Body as a Whole

Back pain

1.6

1.6

2.7

2.8

1.4

1.0

Edema peripheral

0.7

2.4

3.0

3.2

2.9

2.1

Influenza-like symptoms

2.2

2.0

2.2

3.1

2.9

2.0

Injury accidental

2.8

4.0

3.7

3.9

3.9

3.0

Central and Peripheral Nervous System Disorders

Dizziness

2.1

2.6

2.7

4.2

3.4

2.7

Headache

7.1

4.8

8.5

6.6

4.3

5.5

Gastrointestinal System Disorders

Abdominal fullness

2.0

2.1

1.9

3.0

2.9

2.5

Abdominal pain

6.3

7.0

8.2

17.0

8.2

10.1

Diarrhea

4.2

5.4

6.0

10.8

3.9

4.7

Dyspepsia

6.3

7.9

8.7

13.4

15.0

12.9

Flatulence

4.1

2.9

3.5

3.1

7.7

5.4

Nausea

5.9

7.0

6.3

8.4

7.7

8.7

Musculoskeletal System Disorders

Myalgia

1.6

2.0

1.9

2.4

2.4

1.4

Respiratory System Disorders

Sinusitis

2.2

2.6

1.8

1.1

3.4

3.4

Upper respiratory tract infection

6.0

6.7

5.7

6.3

4.3

6.4

Skin and Appendages Disorders

Rash

1.0

1.4

2.1

1.5

0.5

1.4

In these placebo- and active-controlled clinical trials, the discontinuation rate due to adverse events was 7.5% for arthritis patients receiving valdecoxib 10 mg daily, 7.9% for arthritis patients receiving valdecoxib 20 mg daily and 6.0% for patients receiving placebo.

In the seven controlled OA and RA studies, the following adverse events occurred in 0.1 - 1.9% of patients treated with BEXTRA (valdecoxib) 10 - 20 mg daily, regardless of causality.

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 (valdecoxib) :

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 (valdecoxib) . These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to BEXTRA (valdecoxib) , 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