Call Us: 1.800.873.5297


Rituxan risks may change course of treatment

The Food and Drug Administration is weighing whether patients’ course of treatment for the widely used cancer drug Rituxan should be changed. Rituxan may pose less of a risk of developing progressive multifocal leukoencephalitis (PML) if it is used for a shorter period or with breaks, according the FDA and the Wall Street Journal.

The drug is co-marketed by biotechnology companies Genentech Inc. of California and Biogen Idec Inc. of Massachusetts. Rituxan, which is used to treat lymphoma, a cancer of immune-system cells, had $2.6 billion in U.S. sales in 2008.

PML is a viral infection that affects the white matter of the brain. PML is caused by reactivated JC virus. Latent JC virus is present in about 80 percent of adults. Patients with PML exhibit neurological symptoms like confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. PML gets worse over time, and is usually fatal. There is no treatment or cure for the disease. It is often associated with drugs that suppress the immune system.

A study released in March in the medical journal, Blood linked Rituxan to 57 cases of PML between 1997 and 2008. Of 57, 51 died. The median time between their diagnosis and death was about two months.

The study’s researcher commented: “The potential contribution of Rituxan to the development of PML is unknown; however, it cannot be excluded.”

While Rituxan has been linked to a higher number of PML cases, some are not calling for a recall of Rituxan because it is frequently the best option for patients with life-threatening cancer. It is questionable whether the drug should be used in patients who do not have life-threatening diseases. There are typically more options for patients with rheumatoid arthritis, another ailment which Rituxan is approved to treat.

Doctors say Rituxan is also used “off label” for conditions not approved by the FDA, including lupus and psoriasis. FDA officials said they are aware of some off-label uses, which are legal so long as the drug maker does not promote them. Genentech said it doesn’t promote off-label use of Rituxan.

Doctors at the FDA have been looking at the long-term uninterrupted use of Rituxan as a potential factor in PML. By suppressing the immune system, the drug may give free rein to the virus, normally under check, that causes the brain disease.

“We’ve had discussions at the FDA about whether drug holidays or limitations on the duration of therapy might reduce the risk of PML and other serious adverse effects of chronic immunosuppression,” said John Jenkins, director of the FDA’s drug approval section.

Drug holidays themselves can cause problems, though. “Sometimes [after a break from the drug], the disease recurs more severely and requires higher doses to bring the disease back under control,” Dr. Jenkins said.

The FDA warned of the possible link between Rituxan and PML in 2006. Currently, Rituxan’s label has a “black box” warning about PML, the strongest possible warning.

Reports of adverse events associated with Rituxan, including PML, should be reported to the FDA.

The FDA can be contacted via:
Online at
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see:

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.