Safety Alerts & Recalls

What does this mean?

The issue of PML with the use of rituximab has been known for some time. For most patients, the benefit of rituximab will outweigh the risk of PML. However, you may wish to follow up with your doctor to review your benefits of rituximab 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 rituximab or if you think you may be experiencing side effects from this medicine, please follow up with your doctor.

Serious infections Reported with Use of MabThera in Patients with Rheumatoid Arthritis

In the December 2009 Drug Safety Update, the MHRA reported about a third case of progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis treated with rituximab (MabThera). 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 rituximab who has not previously received treatment with a Tumor Necrosis Factor (TNF) antagonist, a class of medications used to treat rheumatoid arthritis. Cases of PML have also been reported in patients with other autoimmune diseases treated with rituximab. The MHRA is reminding health care professionals that rituximab is not indicated for first-line treatment of rheumatoid arthritis.

Rituximab is marketed under the brand name MabThera. Rituximab in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis who have failed to respond to other therapies. Rituximab is also indicated for treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukaemia in combination with chemotherapy.

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Source: MHRA
Publication Date: 2009-12-09
Last Updated: 2010-11-08

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