July 13, 2010: Information About Severe Liver Injury Added to Boxed Warning of Arava
On July 13, 2010 The U.S. Food and
Drug Administration (FDA) announced that it is adding information on severe
liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat
rheumatoid arthritis. FDA is taking this action to highlight the risk of severe
liver injury in patients using this drug and inform consumers how this risk may
be reduced.
FDA previously required a Boxed
Warning stating that leflunomide was contraindicated for use by both pregnant
women and women of childbearing potential who were not using reliable
contraception.
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.
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.
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