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FDA: Fatal Case of Progressive Multifocal Leukoencephalopathy in Patient Receiving Rituximab

ROCKVILLE, Md -- September 11, 2008 -- The US Food and Drug Administration (FDA) and Genentech are notifying healthcare professionals of revisions to prescribing information for rituximab (Rituxan) regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis (RA) who received rituximab in a long-term safety extension clinical study.

The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of rituximab.

Healthcare professionals treating patients with rituximab should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.

In patients who develop PML, rituximab should be discontinued and reductions or discontinuation in concomitant immunosuppressive therapy and appropriate treatment including antiviral therapy should be considered. There are no known interventions that can reliably prevent PML or adequately treat PML if it occurs.

The reported case was confounded by the patient's development of oropharyngeal cancer, which was treated with chemotherapy (a platinum-containing regimen) and radiation therapy 9 months prior to the development of PML.

The patient had longstanding RA treated with immunosuppressants and a complex medical and rheumatologic history including Sjogren's syndrome and undetectable complement C4 levels.

Treatment for RA included methotrexate, steroids, and a tumour necrosis factor (TNF) antagonist prior to rituximab therapy; and methotrexate and steroids during and after rituximab therapy.

The rituximab package insert WARNING section on PML has previously noted reports of PML in patients with haematologic malignancies and autoimmune diseases for which rituximab is not approved. It has been updated to reflect the case of PML in an RA patient treated with rituximab.

The new label changes can be seen here: http://www.fda.gov/medwatch/safety/2008/Rituxan_PI.pdf

Healthcare professionals should report any serious adverse events possibly associated with the use of rituximab to Genentech Drug Safety at 1-888-835-2555. Alternatively, this information may be reported to the FDA's MedWatch reporting system by phone (1-800-FDA-1088), facsimile (1-800-FDA-1078) or the Med Watch website at www.fda.gov/medwatch or mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.


SOURCE: US Food and Drug Administration

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