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FDA: Antirheumatic Drug Gets New Boxed Warning
by -- Beth Gilbert
Updated: Jul 14th 2010
WEDNESDAY, July 14 (HealthDay News) -- The U.S. Food and Drug Administration has added information on risk of severe liver injury to the boxed warning of leflunomide (Arava), a disease-modifying antirheumatic drug.
The agency previously required a boxed warning highlighting that leflunomide was contraindicated in pregnant women, or women of childbearing years who were not using reliable contraception. A bolded warning statement on severe liver injury was added to the leflunomide drug label in 2003 but the FDA has now decided that the information should be included in a boxed warning to emphasize the importance of appropriate patient selection prior to starting treatment and to highlight the importance of monitoring patient's liver function tests during treatment.
The additional information to the boxed warning was added after the FDA identified 49 cases of severe liver injury when reviewing adverse event reports, including 36 cases that required hospitalization and 14 cases of fatal liver failure, between August 2002 and May 2009. In addition, five patients required a liver transplant and nine patients experienced a life-threatening event. Patients with pre-existing liver disease and those taking other drugs known to cause liver injury were identified in the review as having the greatest risk for liver injury. In addition, most patients developed severe liver injury within the first six to 12 months of treatment.
According to a recent FDA safety alert, "only patients for whom the anticipated therapeutic benefit is expected to outweigh the risk of severe liver injury should be considered for leflunomide treatment. Alanine transaminase levels should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter."
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