ADVERSE REACTIONS
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.
Osteoarthritis and Rheumatoid Arthritis
Table 4 lists all adverse events, regardless of causality, that occurred in ≥2.0% of patients receiving BEXTRA 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 Number Treated | Placebo 973 | 10 mg 1214 | 20 mg 1358 | 150 mg 711 | 2400 mg 207 | 1000 mg 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 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:
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 Experience
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: Hypersensitivity reactions (including anaphylactic reactions and angioedema)
Gastrointestinal: Pancreatitis
Skin and appendages: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
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REPORTS OF SUSPECTED BEXTRA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Bextra. The information is not vetted and should not be considered as verified clinical evidence.
Possible Bextra side effects / adverse reactions in 70 year old female
Reported by a individual with unspecified qualification from United States on 2011-10-31
Patient: 70 year old female weighing 80.3 kg (176.7 pounds)
Reactions: Anxiety, Fatigue, Upper Limb Fracture, Drug Ineffective, Bone Pain, Hypotension, Gastrooesophageal Reflux Disease, Herpes Zoster
Suspect drug(s):
Bextra
Administration route: Oral
Indication: Back Disorder
Start date: 1997-01-01
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Other drugs received by patient: Lisinopril
Possible Bextra side effects / adverse reactions in 58 year old male
Reported by a consumer/non-health professional from United States on 2012-02-15
Patient: 58 year old male weighing 72.6 kg (159.7 pounds)
Reactions: Cerebrovascular Accident, Cardiac Disorder
Adverse event resulted in: death
Suspect drug(s):
Bextra
Possible Bextra side effects / adverse reactions in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 61 year old female weighing 77.1 kg (169.6 pounds)
Reactions: Nerve Injury, Diabetes Mellitus, Drug Ineffective, Chills, Constipation, Fall, Blood Creatinine Increased, Vomiting, Renal Disorder, Nausea, Mental Impairment, Renal Impairment, Panic Attack, Kidney Small, Blood Potassium Decreased, Arthralgia, Swelling, Dehydration, Memory Impairment, Gait Disturbance, Feeling Abnormal
Suspect drug(s):
Bextra
Dosage: unk
Administration route: Oral
Indication: Arthritis
End date: 2005-01-01
Celebrex
Dosage: 1 df, 1x/day
Administration route: Oral
Indication: Arthritis
Start date: 1999-01-01
End date: 2002-01-01
Cymbalta
Administration route: Oral
Indication: Neuralgia
Gabitril
Dosage: 10 mg, 1x/day
Administration route: Oral
Indication: Neuralgia
Maxzide
Dosage: unk
Administration route: Oral
Indication: Hypertension
Morphine Sulfate
Dosage: unk
Neurontin
Dosage: 100 mg, daily
Administration route: Oral
Indication: Nerve Injury
Neurontin
Dosage: 100 mg, 2x/day
Neurontin
Dosage: 600 mg, 3x/day
Indication: Pain
Neurontin
Dosage: 300 mg, 2x/day
Potassium Chloride
Dosage: unk
Indication: Blood Potassium Decreased
Start date: 2012-01-01
Topamax
Dosage: unk
Administration route: Oral
Indication: Neuralgia
Toprol-XL
Dosage: unk
Administration route: Oral
Indication: Hypertension
Zyrtec
Dosage: 10 mg, daily
Indication: House Dust Allergy
Other drugs received by patient: Toprol-XL; Lyrica; Lipitor; Aspirin; Norvasc
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