Valdecoxib

What is Valdecoxib

NOTE: This drug is discontinued in the US.

Valdecoxib is a selective cyclooxygenase-2 (COX-2), nonsteroidal anti-inflammatory drug (NSAID).

Valdecoxib exhibits anti-inflammatory, analgesic, and antipyretic activities but does not inhibit platelet aggregation. It is indicated for the management of dysmenorrhea, osteoarthritis, and rheumatoid arthritis.

Clinical trials have demonstrated similar efficacy and a significantly lower incidence of GI side effects for valdecoxib as compared to naproxen for symptomatic management of osteoarthritis or rheumatoid arthritis. A supplemental NDA for the treatment of migraine was filed with the FDA in April 2004. Valdecoxib was FDA-approved in November 2001.

On April 7, 2005, Pfizer announced a voluntary suspension of valdecoxib from the U.S. and European Union markets.

Although the cardiovascular risk of valdecoxib could not be differentiated from other NSAIDs, the FDA has concluded that the additional, increased risk of rare but serious skin reactions associated with valdecoxib warrants its withdrawal from the market.

Patients who are taking valdecoxib should discuss other treatment options with their physicians.

Brand Name

Bextra

Indications

  1. bone pain
  2. dental pain
  3. dysmenorrhea
  4. moderate pain
  5. osteoarthritis
  6. rheumatoid arthritis
  7. severe pain

For the management of signs and symptoms of osteoarthritis and rheumatoid arthritis

Side Effects

  1. abdominal pain
  2. anaphylactoid reactions
  3. anemia
  4. angina
  5. angioedema
  6. aseptic meningitis
  7. azotemia
  8. back pain
  9. cardiomyopathy
  10. chest pain (unspecified)
  11. diarrhea
  12. dizziness
  13. dyspepsia
  14. dysphagia
  15. edema
  16. elevated hepatic enzymes
  17. erythema multiforme
  18. esophageal stricture
  19. esophageal ulceration
  20. esophagitis
  21. exfoliative dermatitis
  22. flatulence
  23. GI bleeding
  24. headache
  25. heart failure
  26. hematemesis
  27. hyperkalemia
  28. hypertension
  29. hyponatremia
  30. hypotension
  31. melena
  32. myalgia
  33. myocardial infarction
  34. nausea
  35. odynophagia
  36. peptic ulcer
  37. peripheral edema
  38. phlebitis
  39. proteinuria
  40. pulmonary embolism
  41. pyrosis (heartburn)
  42. rash
  43. renal papillary necrosis
  44. sinusitis
  45. Stevens-Johnson syndrome
  46. stroke
  47. thrombosis
  48. toxic epidermal necrolysis
  49. urticaria
  50. vomiting

Monitoring Parameters

  • (drug no longer available)
  • CBC
  • LFTs
  • serum creatinine/BUN
  • stool guaiac

Contraindications

  • acute bronchospasm
  • alcoholism
  • anemia
  • angioedema
  • anticoagulant therapy
  • asthma
  • bone marrow suppression
  • breast-feeding
  • cardiac disease
  • cerebrovascular disease
  • chemotherapy
  • children
  • coronary artery bypass graft surgery (CABG)
  • coronary artery disease
  • corticosteroid therapy
  • dehydration
  • diabetes mellitus
  • geriatric
  • GI bleeding
  • GI disease
  • GI perforation
  • heart failure
  • hepatic disease
  • hepatitis
  • hypertension
  • hypovolemia
  • immunosuppression
  • infants
  • jaundice
  • labor
  • lactase deficiency
  • nasal polyps
  • neonates
  • neutropenia
  • NSAID hypersensitivity
  • obstetric delivery
  • peptic ulcer disease
  • peripheral edema
  • peripheral vascular disease
  • pregnancy
  • renal disease
  • renal failure
  • renal impairment
  • rheumatoid arthritis
  • salicylate hypersensitivity
  • serious rash
  • stroke
  • sulfonamide hypersensitivity
  • systemic lupus erythematosus (SLE)
  • tobacco smoking
  • urticaria

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