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Rituxan Side Effects Could Result In Brain Disease Lawsuits

Rituxan | Lawsuits, Lawyers | Side Effects: Brain Disease, Progressive Multifocal Leukoencephalopathy, PML, Abdominal Pain, Bowel Obstruction, Perforation

On December 19, 2006 Genentech issued a warning to healthcare providers for their oncology drug Rituxan, advising them that the drug has been linked to the deaths of two lupus patients from a rare brain disease, called Progressive multifocal leukoencephalopathy (PML). On November 10, 2006, Health Canada and the manufacturer of Rituxan (Generic: rituximab) issued a new safety warning for the drug. Reports of Bowel obstruction and gastrointestinal perforation lead to the new safety warning for Rituxan (Generic: rituximab). Rituxan is prescribed to treat B-cell non-Hodgkin's Lymphoma (NHL) and Rheumatoid Arthritis (RA). Rituxan first gained FDA approval in 1997. Rituxan is manufactured by Genentech, Inc.

Post-market & Clinical Study of Rituxan

Reports of abdominal pain, bowel obstruction, and perforation, in some cases leading to death, have been observed in patients receiving Rituxan. The bulk of reports, including all deaths, have occurred in patients receiving Rituxan in combination with chemotherapy for the Non-Hodgkin's Lymphoma (NHL) indication.

A causal relationship connecting Rituxan and these events has not been established. In post-marketing reports of patients with Non-Hodgkin's Lymphoma (NHL), the mean time to onset of symptoms was 6 days from the start of therapy (range 1 day to 77 days) for documented gastrointestinal perforation. Complaints of abdominal pain, particularly early in the course of treatment, should prompt a thorough diagnostic assessment and appropriate treatment.

Discoverings from the pharmacovigilance database for Rituxan point outs that 47 cases of bowel obstruction (9 deaths), and 37 cases of gastrointestinal perforation (4 deaths), have been reported in Rituxan patients, based on an approximately 730,000 cumulative patient exposure. The reports originate from both spontaneous sources and clinical studies and the majority of these cases were reported for the Non-Hodgkin's Lymphoma (NHL) indication. Analysis of the data from the majority of the 47 cases of bowel obstruction was difficult due to multiple risk factors, including gastrointestinal lymphoma, various other gastrointestinal disorders, and concomitant treatments, such as chemotherapy, steroids, and radiation therapy.

The location of gastrointestinal perforation in the cases of Non-Hodgkin's Lymphoma (NHL) included both the upper and lower gastrointestinal tract. Regular risk factors in these reports included a history of gastrointestinal lymphoma at the time of the event and documented concomitant medications, including chemotherapy and prednisolone. Despite these confounding factors, a contributory role of Rituxan in causing gastrointestinal perforation in patients diagnosed with Non-Hodgkin's Lymphoma (NHL) has not been excluded. In addition, a pooled analysis of clinical trials in patients with Non-Hodgkin's Lymphoma (NHL) has indicated a higher incidence of gastrointestinal perforation in the arms treated with Rituxan/chemotherapy compared to the arms treated with chemotherapy alone (0.38% vs 0.15%).  There have been 2 reports of bowel obstruction (1 death) and 2 reports of gastrointestinal perforation originating from Canada.

Legal help for Rituxan users

If you or a loved one took Rituxan and you suffered Bowel Obstruction, Gastrointestinal Perforation or any other injury, contact Parker & Waichman, LLP for a free case evaluation. Call 1-800-YOURLAWYER (1-800-968-7529) or fill out the short form to the right.


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Third Rituxan Patient Diagnosed with PML

Oct 26, 2009 | Parker Waichman LLP
A third Rituxan patient has developed a serious and often fatal brain infection called progressive multifocal leukoencephalopathy (PML).   According to a statement posted on the Food & Drug Administration (FDA) Web site, this is the first case of PML in a patient with rheumatoid arthritis  treated with Rituxan who has not previously received treatment with a TNF antagonist.Rituxan, a powerful medication that suppresses the immune system, is the most important and widely used...

Rituxan - PML Link Could Spark FDA Action

Jun 1, 2009 | Parker Waichman LLP
U.S. health regulators are taking a look at the lymphoma drug Rituxan because of its possible association with progressive multifocal leukoencephalitis (PML), an often fatal brain infection.  According to The Wall Street Journal, the Food & Drug Administration (FDA) is trying to determine if  patients should take Rituxan for shorter periods, or take breaks from therapy to lessen the risk that they will develop PML.Rituxan,  a powerful medication that suppresses the immune...

Study Finds 57 Rituxan Patients Developed PML

May 20, 2009 | Parker Waichman LLP
Patients taking Rituxan may be at risk of developing a serious, and often fatal brain infection called progressive multifocal leukoencephalitis (PML), according to the findings of a new study.  The study, published in the journal Blood, reports on 57 cases of PML that developed in patients taking Rituxan between 1997 and 2008. The study, which is detailed in Science Daily, was conducted by researchers with the Northwestern University Feinberg School of Medicine RADAR project.  RADAR...

Rituxan Treatment for Rheumatoid Arthritis Implicated in Brain Infection

Sep 11, 2008 | Parker Waichman LLP
The labeling for Rituxan is being revised following a report that a patient administered the drug to treat rheumatoid arthritis had died of the brain infection progressive multifocal leukoencephalopathy (PML).  Cases of PML have previously been reported in patients taking Rituxan for unapproved uses, such as blood cancer and lupus.  But according to the Food & Drug Administration (FDA),  this is the first report of the infection in an individual undergoing treat for ...

Rituxan Therapy Linked to Fatal Brain Infection

Aug 14, 2007 | Parker Waichman LLP, LLP
Rituxan, a powerful cancer medication, has been linked to a fatal brain infection called progressive multifocal leukoencephalopathy (PML).  PML is a viral infection for which there is no treatment.   The disease is usually fatal, and at least two patients undergoing Rituxan therapy have died.According to the Food and Drug Administration (FDA), two patients developed PML after they were given Rituxan as a treatment for systemic lupus erythematosus (SLE).  Rituxan is not...

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