This was successfully posted to your pofile.
This box will close automatically in a few seconds. Close this window
We don't have an e-mail address on file for you. To use AAFP Connection, you must have an e-mail address in our records. Click Here
FDA Adds Information on Severe Liver Injury to Leflunomide's Boxed Warning
Agency Acts in Wake of Dozens of Case Reports, 14 Deaths
By News Staff
The following information about liver injury was added to the boxed warning:
- patients with elevated liver enzymes (i.e., alanine transaminase, or ALT, levels greater than two times the upper limit of normal) and those with pre-existing liver disease should not receive leflunomide;
- liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter;
- if ALT levels rise to greater than two times the upper limit of normal while a patient is on leflunomide, the medication should be stopped, a cholestyramine washout should be performed to speed removal of the drug from the body, and follow-up liver function tests should be conducted at least weekly until the ALT value is within normal range; and
- caution should be used in patients who are taking other drugs that can cause liver injury.
In addition, 14 patients had pre-existing liver disease, such as acute or chronic infection with hepatitis B or hepatitis C virus, and/or a history of alcohol abuse.
Although many patients were taking other drugs or had pre-existing liver disease, the FDA concluded that the use of leflunomide was associated with the development of severe liver injury in the affected patients.
The agency advised physicians that only patients for whom the anticipated therapeutic benefit is expected to outweigh the risk of severe liver injury should be considered for leflunomide treatment.
Patients who experience signs or symptoms of severe liver injury -- itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools -- should contact their physicians right away, according to the FDA.
Side effects associated with leflunomide use should be reported to the FDA's MedWatch program.
FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)
(July 13, 2010)
CDC: Rheumatoid Arthritis