SAFETY ALERT - FDA adds information to Arava (leflunomide) boxed warning

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FDA

Posted 13 Jul 2010

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.

[07/13/2010 - Drug Safety Communication - FDA]

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

Products/ucm218912.htm

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