Leflunomide use during the first 33 months after food and drug administration approval: experience with a national cohort of 3,325 patients.

Academic Article


  • OBJECTIVE: To describe leflunomide (LEF) use in a national cohort of 3,325 veterans. METHODS: Prescriptions for LEF and 9 disease-modifying antirheumatic drugs written between October 1998 and June 2001 at all Veterans Affairs (VA) medical centers were obtained from VA national databases. RESULTS: LEF was initiated with a loading dose of 100 mg daily for 3 days in 61% of patients, and 42% of patients discontinued LEF. LEF was more likely to be discontinued if a 3-day 100-mg loading dose was prescribed, patients were younger than 44 years or older than 75 years, or reported an annual family income <$60,000. Review of medical records of 291 discontinuers revealed that the most common reasons for discontinuation were inefficacy (30%), gastrointestinal symptoms (29%), medication noncompliance or lost to followup (14%), and elevated liver enzymes (5%). CONCLUSION: LEF is relatively safe in clinical practice. The VA's national databases provide an excellent, inexpensive resource for postmarketing evaluation of rheumatologic medications.
  • Published In


  • Adult, Aged, Anti-Inflammatory Agents, Non-Steroidal, Antirheumatic Agents, Arthritis, Rheumatoid, Cohort Studies, Databases, Factual, Drug Approval, Drug Therapy, Combination, Female, Hospitals, Veterans, Humans, Isoxazoles, Leflunomide, Male, Middle Aged, Military Medicine, Product Surveillance, Postmarketing, Treatment Failure, United States, United States Department of Veterans Affairs
  • Digital Object Identifier (doi)

    Author List

  • Siva C; Eisen SA; Shepherd R; Cunningham F; Fang MA; Finch W; Salisbury D; Singh JA; Stern R; Zarabadi SA
  • Start Page

  • 745
  • End Page

  • 751
  • Volume

  • 49
  • Issue

  • 6