FDA Warns of Safety Concern Regarding Rituxan in New Patient Population

BETHESDA, MD -- December 19, 2006 -- The Food and Drug Administration 
(FDA) is alerting health care professionals and patients treated with 
Rituxan (rituximab) to reports of an emerging risk of a serious side 
effect in patients receiving or who have used Rituxan.

FDA recently learned that two patients who were treated with Rituxan 
for systemic lupus erythematosus (SLE) developed progressive 
multifocal leukoencephalopathy (PML), a fatal viral infection of the 
central nervous system. This side effect has been reported in 
patients as late as 12 months after their last dose of Rituxan.

SLE is not an approved indication for Rituxan. Rituxan is approved 
only for the treatment of patients with non-Hodgkin's lymphoma and 
patients with rheumatoid arthritis whose disease no longer responds 
to other common treatments.

"Rituxan is used in both approved and off-label settings, and 
therefore it is very important for prescribers as well as patients to 
be aware of these new reports of the risk of PML," said Dr. Steven 
Galson, director of FDA's Center for Drug Evaluation and Research. 
"Patients who are being treated or have been treated with Rituxan who 
experience any major changes in vision, balance, or coordination, or 
who experience confusion, should promptly call their doctor."

Rituxan, which has been marketed since 1997, acts on the body's 
immune system by decreasing certain types of white blood cells. This 
makes the drug effective in treating lymphoma and rheumatoid 
arthritis, but it also increases the body's susceptibility to 
infection. The Rituxan label was updated in February 2006 to include 
postmarketing reports of cases of serious viral illnesses, including 
PML, in patients with lymphoma who received Rituxan. There have been 
23 confirmed cases of PML in patients with lymphoid malignancies 
either during or after completion of treatment with Rituxan. The 
majority of these patients also had received other drugs known to 
affect the immune system.

Additionally, cases of PML have occurred in patients who have not 
received Rituxan. Most reports have been in patients with a 
compromised immune system, either due to medical conditions (lymphoma 
or blood cancers, HIV infection and congenital immunodeficiency 
syndromes) or medical treatments (cancer chemotherapy and 
immunosuppressive medications in organ transplant recipients). There 
also have been literature reports of PML in patients with SLE who did 
not receive Rituxan, but had received other immunosuppressive drugs. 
Currently FDA is working with Genentech, the drug's sponsor, to add 
this recent information on PML to the drug label.

Health care professionals should report any serious adverse events 
possibly associated with the use of Rituxan to FDA's MedWatch Adverse 
Event Reporting program online [at www.fda.gov/MedWatch/report.htm], 
by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 
3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] 
by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or 
fax [1-800-FDA-0178].

Rituxan is manufactured by Genentech, Inc. of South San Francisco, 
Calif.


SOURCE: Genentech, Inc.