NEWS - Rituxan (rituximab) linked to a fatal case of PML

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Medscape

Yael Waknine

Rituxan Linked to Fatal PML Case

September 11, 2008 — The safety labeling for rituximab intravenous

infusion (Rituxan, Genentech, Inc, comarketed with Biogen Idec, Inc)

has been updated to reflect a fatal case of progressive multifocal

leukoencephalopathy (PML) in a rheumatoid arthritis (RA) patient, the

US Food and Drug Administration (FDA) announced today.

The patient was diagnosed about 18 months after receiving the last

dose of rituximab as part of a long-term safety clinical extension

study, according to an alert issued by MedWatch, the FDA's safety

information and adverse event reporting program. Previously,

Cunningham (JC) virus reactivation leading to PML had only been

reported with use of rituximab for hematologic malignancies and

off-label autoimmune diseases.

In a letter to healthcare professionals, the manufacturer noted

several confounding factors in the RA case: an oropharyngeal cancer

that was treated with platinum-based chemotherapy 9 months before the

patient developed PML, a complex history that included Sjogren's

syndrome and undetectable complement C4 levels, and a long-term

history of immunosuppressive therapy that continued during and after

rituximab was administered.

Healthcare professionals treating patients with rituximab are advised

to maintain an index of suspicion for PML in any patient presenting

with new-onset neurologic manifestations. A neurologic consult with

brain magnetic resonance imaging and lumbar puncture should be

considered as clinically indicated.

Rituximab therapy should be discontinued in patients who develop PML;

dose reductions and discontinuation should be considered for any

concomitantly administered immunosuppressants.

Rituximab is a CD20-directed cytolytic monoclonal antibody indicated

for the treatment of non-Hodgkin's lymphoma and, in combination with

methotrexate, for the treatment of moderately to severely active RA in

patients who have had inadequate response to 1 or more anti-tumor

necrosis factor therapies.

Adverse events related to use of rituximab should be reported to the

FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by

fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by

mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

http://www.medscape.com/viewarticle/580407

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