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.
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    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