Safety Alerts & Recalls

What does this mean?

The issue of PML with the use of Rituxan has been known for some time and the product currently has a black box warning to inform physicians of this safety issue. For most patients, the benefit of Rituxan will outweigh the risk of PML. However, you may wish to follow up with your doctor to review your benefits of Rituxan treatment and the updated PML risk information. You should also monitor for symptoms of PML and contact your doctor immediately if you notice any changes such as weakness in the hands or legs, difficulty thinking or concentrating, or a loss of coordination - which could be early signs of the condition.

If you have any questions about the safety of Rituxan or if you think you may be experiencing side effects from this medicine, please follow up with your doctor.

Update on Risk of Progressive Multifocal Leukoencephalopathy (PML) with Use of Rituxan

Genentech and FDA have received a report of a third case of progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis treated with Rituxan. PML is a rare but life threatening disease of the brain and nervous system. This is the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a Tumor Necrosis Factor (TNF) antagonist, a class of medications used to treat rheumatoid arthritis. The overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare. There have been 3 reports of PML in approximately 100,000 rheumatoid arthritis patients that have been exposed to Rituxan. However, information to date suggests that patients with rheumatoid arthritis who receive Rituxan have an increased risk of PML.

Rituxan contains the active ingredient rituximab. Rituxan is used to treat rheumatoid arthritis (RA) and is also used to treat certain types of non-Hodgkin's lymphoma (NHL).

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Source: FDA
Publication Date: 2009-10-26
Last Updated: 2009-12-05

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