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Valdecoxib Side Effects

Applies to valdecoxib: oral tablet

Cardiovascular

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Endocrine

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

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.[Ref]

Hepatic

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

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.[Ref]

Musculoskeletal

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

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.[Ref]

Psychiatric

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

Hematologic

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

Ocular

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

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.[Ref]

Hypersensitivity

Hypersensitivity side effects have included aggravated allergies and allergic reaction.[Ref]

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.[Ref]

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).[Ref]

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.[Ref]

References

1. "Product Information. Bextra (valdecoxib)." Pharmacia Corporation, Peapack, NJ.

2. FDA. U.S. Food and Drug Administration "Medwatch - The FDA Safety Information and Adverse Event Reporting Program - Strengthened warnings on Bextra (valdecoxib) Available from: URL: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Bextra." ([2004 Dec 10]):

3. Pfizer News Release "Pfizer provides information to healthcare professionals about its cox-2 medicine Bextra (valdecoxib). Available from: URL: http://www.pfizer.com/are/news_releases/2004pr/mn_2004_1015.html." ([2004 Oct 15]):

4. Glasser DL, Burroughs SH "Valdecoxib-induced toxic epidermal necrolysis in a patient allergic to sulfa drugs." Pharmacotherapy 23 (2003): 551-3

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Some side effects may not be reported. You may report them to the FDA.