FDA Issues New Box Warning for Arava
The FDA has issued a new box warning for Arava, a drug used to treat rheumatoid arthritis.
The new warning for Arava, also known as leflunomide, highlights the risk of severe liver injury in patients and how this risk may be reduced.
The FDA recommends the following information be added to the boxed warning for Arava:
- Patients with pre-existing liver disease should not take Arava.
- Patients with elevated liver enzymes should not take Arava.
- Caution should be used in patients who are taking other medication that can cause liver injury.
- Liver enzymes should be monitored at least monthly for three months after starting Arava and at least quarterly thereafter.
For more information, please read the complete MedWatch 2010 Safety Summary.
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