Safety Alerts & Recalls

What does this mean?

The prescribing information for leflunomide has contained a warning statement on severe liver injury since 2003 and most doctors are aware of this risk in patients using this medicine. For most patients, the benefits of leflunomide in treating rheumatoid arthritis will continue to outweigh the risk of side effects.

If you take leflunomide or the brand Arava, you should be aware that severe liver injury is a rare, but serious side effect of this drug. You may wish to further discuss this risk with your doctor or other healthcare professional, especially if you have a history of liver problems. If you experience itching; yellow eyes or skin; dark urine; loss of appetite; or light-colored stools should contact your doctor or other healthcare professional right away - these may be signs of severe liver injury. If you have any other concerns about this medicine, please talk to your doctor or healthcare professional.

Leflunomide (Arava): FDA Adds Information on Severe Liver Injury to the Boxed Warning

The U.S. Food and Drug Administration (FDA) is adding information on severe liver injury to the Boxed Warning of leflunomide (Arava) to highlight the risk of severe liver injury in patients using this medicine. Leflunomide is used to treat rheumatoid arthritis. It is also sold under the brand name Arava.

The information on severe liver injury now being added to the Boxed Warning states: - Patients with liver disease should not receive leflunomide.

- Patients with elevated liver enzymes 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 liver enzymes become too high while a patient is on leflunomide - leflunomide should be stopped, and additional treatment and monitoring provided as described in the prescribing information.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-07-13
Last Updated: 2010-07-14

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