The FDA will require that the label for the rheumatoid arthritis drug leflunomide (Arava) carry an added warning for severe liver injury. The label already warns against the drug's use in pregnant women and those of childbearing potential.
The new warning comes after the FDA received 49 reports of severe liver injury, including 14 instances of fatal liver failure, from 2002 to 2009. Risk for liver injury was higher among patients using other drugs associated with liver injury and patients with liver disease.
Clinicians should monitor liver enzymes at least monthly for 3 months after beginning the drug. After that, enzymes should be monitored every quarter. Treatment should be halted if liver enzymes rise to two times the upper limit of normal.
FDA MedWatch alert
The new warning comes after the FDA received 49 reports of severe liver injury, including 14 instances of fatal liver failure, from 2002 to 2009. Risk for liver injury was higher among patients using other drugs associated with liver injury and patients with liver disease.
Clinicians should monitor liver enzymes at least monthly for 3 months after beginning the drug. After that, enzymes should be monitored every quarter. Treatment should be halted if liver enzymes rise to two times the upper limit of normal.
FDA MedWatch alert
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