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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