Arava Boxed Warning updated to include severe liver injury

The FDA has updated the Boxed Warning of Arava (leflunomide, from sanofi aventis) to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. The Boxed Warning now additionally states that:
  • Patients with pre-existing liver disease should not receive leflunomide
  • Patients with elevated liver enzymes (ALT >2X ULN) should not receive leflunomide.
  • Caution should be used in patients who are taking other drugs that can cause liver injury
  • Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter
  • If the ALT rises to >2X ULN while the patient is on leflunomide – leflunomide should be stopped, cholestryamine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range
 
The previously required Boxed Warning states that leflunomide is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception.

Arava is indicated for active rheumatoid arthritis to reduce signs/symptoms, inhibit structural damage, and improve physical function. Arava may be used with aspirin, NSAIDs, and/or low-dose corticosteroids.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218912.htm.