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Rituxan
Injured by Rituxan?
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.The following information was determined based on post-market and clinical study data 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 ealuation. Call 1-800-LAW-INFO (1-800-529-4636) or fill out the short form to the right.
RituxanRSS Feed
Rituxan Therapy Linked to Fatal Brain Infection
Aug 14, 2007 | Parker Waichman Alonso, 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...
Biotech firms' drug is linked to deaths
Dec 19, 2006 | Los Angeles Times
The bestselling medicine for two of the country's biggest biotech drug companies has been further linked to a rare and deadly brain infection, U.S. health officials warned Monday. The news could hurt efforts by Genentech Inc. and Biogen Idec Inc. to expand approved treatments for Rituxan. Patients taking Rituxan, a drug approved to treat rheumatoid arthritis and non-Hodgkins lymphoma, have been known to contract the rare brain infection. But two patients being treated for lupus also have died...
Biogen, Genentech issue warning for Rituxan
Dec 19, 2006 | www.cbsmarketwatch.com
Biogen Idec and Genentech have 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. According to an advisory sent out by the Food and Drug Administration early Tuesday, Biogen and Genentech have sent a letter to healthcare providers informing them that two lupus patients taking Rituxan died of the rare brain disorder PML, an illness generally seen in patients...
Rituxan (rituxamab) Linked to Two Deaths in Lupus Patients
Dec 19, 2006 | www.medpagetodaycom
Two patients treated with the immune modulator Rituxan (rituximab) for systemic lupus erythmatosus (SLE) have died of progressive multifocal leukoencephalopathy (PML), the FDA warned physicians. The FDA said that PML, a viral infection of the central nervous system, has been reported in patients as late as 12 months after their last dose of Rituxan. PML is caused by reactivated JC virus which is present in about 80% of adults. SLE is not an approved indication for Rituxan. It is indicated for...
Off-Label Use of Rituxan Linked to Fatal Leukoencephalopathy
Dec 19, 2006 | www.medscape.com
The US Food and Drug Administration (FDA) is warning healthcare professionals regarding the risk for progressive multifocal leukoencephalopathy (PML) in patients receiving rituximab intravenous infusion (Rituxan, made by Genentech, Inc, and Biogen Idec, Inc) for the treatment of systemic lupus erythematosus (SLE), an off-label indication. The warning was based on 2 fatal cases of PML in patients with SLE receiving rituximab, according to an alert sent today from MedWatch, the FDA's safety...
Defective Drugs
Quick Facts
Rituxan Reference Guide
Generic Name
Rituximab
Date Approved
1997
Manufacturer
Genetech
Status
11/10/06 warning Approved Uses
Non-Hodgkin's Lymphoma
Rheumatoid Arthritis
Serious Side Effects
Bowel obstruction
Gastrointestinal perforation
PML
Death Related Topic
PML
Dangerous Drugs
Diseases
Rituximab
Date Approved
1997
Manufacturer
Genetech
Status
11/10/06 warning Approved Uses
Non-Hodgkin's Lymphoma
Rheumatoid Arthritis
Serious Side Effects
Bowel obstruction
Gastrointestinal perforation
PML
Death Related Topic
PML
Dangerous Drugs
Diseases
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