Bextra Side Effects

Generic Name: valdecoxib

Please note - some side effects for Bextra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Bextra Side Effects - for the Professional

Bextra

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.

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

Side Effects by Body System

Cardiovascular

An increase in cardiovascular thromboembolic events (i.e., myocardial infarction, stroke, deep vein thrombosis (leg), and pulmonary embolism) have been reported in post CABG patients (n=1500) treated with valdecoxib compared to placebo. The risk of the intravenous form is higher (2%) than the oral form (1%) immediately following CABG surgery.

Studies to evaluate valdecoxib's long-term cardiovascular safety profile in patients with arthritis are being planned by the makers of the drug.

Cardiovascular side effects reported in less than 2% of patients have included aggravated hypertension, aneurysm, angina pectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, and hypotension. A greater frequency of cardiovascular events has been reported in patients given valdecoxib following a coronary artery bypass grafting surgery than in those given standard pain treatment.

Nervous system

Nervous side effects have included headache and dizziness. Other side effects reported have included cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, tremor, twitching, convulsions, and vertigo.

Dermatologic

In a recent letter to healthcare professionals sent by the manufacturer of valdecoxib, the following postmarketing dermatologic adverse effects have been reported: erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Data obtained from postmarketing adverse event reporting suggest that the skin reactions have occurred primarily within the first two weeks of valdecoxib therapy.

Toxic epidermal necrolysis has been reported in a 55-year-old woman, with a documented sulfa allergy, after taking valdecoxib for 8 days.

Dermatologic side effects have included serious, potentially fatal skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. These reactions are most likely to occur in the first two weeks of treatment, but can occur any time during therapy. In a few cases these reactions have resulted in death. The reported rate of these serious skin reactions appears to be greater for valdecoxib than other COX-2 agents.

Acne, alopecia, dermatitis, fungal dermatitis, eczema, photosensitivity allergic reaction, pruritus, erythematous rash, maculopapular rash, psoriaform rash, dry skin, skin hypertrophy, skin ulceration, increased sweating, and urticaria have been reported in less than 2% of patients.

Endocrine

Endocrine side effects reported in less than 2% of patients have included goiter.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, dyspepsia, flatulence, and nausea. Other side effects reported have included abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroesophageal reflux, hematemesis, hematochezia, melena, tenesmus, and vomiting.

Pancreatitis has been reported during the postmarketing period. It is not possible to estimate the frequency or to establish causality.

Hepatic

Hepatic side effects have included cholelithiasis, hepatitis, abnormal hepatic function, increased ALT, and increased AST.

Metabolic

Metabolic side effects have included increases in alkaline phosphatase, BUN, CPK, and creatinine, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, increased LDH, increased thirst, increases and decreases in weight, and xerophthalmia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, accidental fracture, myalgia, neck stiffness, osteoporosis, synovitis, and tendonitis.

Respiratory

Respiratory side effects have included sinusitis and upper respiratory tract infection. Other side effects have included abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis, pneumonia, pharyngitis, pleurisy, and rhinitis.

Psychiatric

Psychiatric side effects have included anorexia, anxiety, increased appetite, confusion, depression, insomnia, nervousness, morbid dreaming, and somnolence.

Hematologic

Hematologic side effects have included anemia, ecchymosis, eosinophilia, epistaxis, hematoma, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia, and thrombocytopenia.

Ocular

Ocular side effects have included blurred vision, cataract, conjunctival hemorrhage, conjunctivitis, eye pain, keratitis, and abnormal vision.

Genitourinary

Genitourinary side effects have included albuminuria, cystitis, dysuria, hematuria, micturition frequency increased, pyuria, urinary incontinence, and urinary tract infection. Female patients have reported amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, and vaginal hemorrhage. Male patients have reported impotence and prostatic disorder.

Hypersensitivity

Hypersensitivity side effects have included aggravated allergies and allergic reaction.

General

General side effects have included asthenia, chest pain, chills, cysts, generalized edema, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, and peripheral pain.

In a recent letter to healthcare professionals sent by the manufacturer of valdecoxib, postmarketing general adverse effects have included anaphylactic reactions and angioedema (hypersensitivity reactions).

Other

Resistance mechanism disorder side effects reported in less than 2% of patients have included herpes simplex, herpes zoster, fungal infection, soft tissue infection, viral infection, moniliasis, genital moniliasis, and otitis media.

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