Arava (leflunomide): Boxed Warning- Risk of Severe Liver Injury

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Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

AUDIENCE: Rheumatology, Family Practice

ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of

Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the

risk of severe liver injury in patients using this drug and how this risk may be

reduced. FDA previously required a Boxed Warning stating that leflunomide was

contraindicated in pregnant women, or women of childbearing potential who were

not using reliable contraception.

BACKGROUND: The decision to add information on severe liver injury to the Boxed

Warning was based on FDA’s review of adverse event reports which identified 49

cases of severe liver injury, including 14 cases of fatal liver failure, between

August 2002 and May 2009. In this review, the greatest risk for liver injury was

seen in patients taking other drugs known to cause liver injury, and patients

with pre-existing liver disease.

RECOMMENDATIONS: The information on severe liver injury being added to the Boxed

Warning states:

Patients with pre-existing liver disease should not receive leflunomide.

Patients with elevated liver enzymes (ALT greater than two times the upper limit

of normal) 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 greater than two times the upper limit of normal 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.

Read the MedWatch safety alert, including a link to the Drug Safety

Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm218912.htm

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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