http://www.yourlawyer.com/topics/overview/rituxan Sat, 21 Nov 2009 07:34:40 -0800 pixel-app en http://www.yourlawyer.com/articles/read/17180 Mon, 26 Oct 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/17180 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 cancer drug for lymphoma. It is also approved as a therapy for rheumatoid arthritis, and is used off-label to treat multiple sclerosis, lupus erythematosus and autoimmune anemias.

In February 2006, the labeling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML. At present, the Rituxan PML warning is contained in a “Black Box”, the FDA’s strongest safety alert.

PML is a viral infection that affects the white matter of the brain. 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.

According to a "Dear Healthcare Provider" letter issued by Genentech, the third Rituxan PML case occurred in a 73-year old woman with a diagnosis of seronegative rheumatoid arthritis of 3 years who had received a course of Rituxan in February 2009.  The letter did not say whether the woman was still alive, but two other PML victims who had taken Rituxan have died.

According to the letter, the overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed). However, the information to date suggests that patients with rheumatoid arthritis who receive Rituxan have an increased risk of PML

The letter advises physicians to  consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. In patients who develop PML, Rituxan should be discontinued.

In June, the FDA announced that it was investigating a possible Rituxan-PML link.  At the time, The Wall Street Journal reported that doctors at the FDA were trying to determine if long-term, uninterrupted Rituxan therapy may play a role in the development of PML. The agency has discussed whether a “drug holiday” – an interruption in therapy – might mitigate the risk of PML, the report said. But that could be a problem for many lymphoma patient, as a break could lead to a recurrence of the disease that is more difficult to treat. In such a case, higher doses of Rituxan are needed to bring the cancer under control, the Journal said.

]]> http://www.yourlawyer.com/articles/read/16603 Mon, 01 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16603 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 system, is the most important and widely used cancer drug for lymphoma.  It is also approved as a therapy for rheumatoid arthritis, and is used off-label to treat multiple sclerosis, lupus erythematosus and autoimmune anemias.

In February 2006, the labeling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML.  At present, the Rituxan PML warning is contained in a "Black Box", the FDA's strongest safety alert, The Wall Street Journal said.

PML is a viral infection that affects the white matter of the brain. 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.

As we reported last month, a study published in the journal Blood found that 57 patients taking Rituxan had developed PML between 1997 and 2008.  The study, conducted by researchers with the Northwestern University Feinberg School of Medicine RADAR (Research on Adverse Drug Events and Reports) project, also found that on average, average, these PML patients died just two months after being diagnosed.  In many cases, PML patients taking Rituxan were misdiagnosed with disease like dementia and Alzheimer’s.

The PML patients in the RADAR study were using Rituxan as a treatment for anemia, rheumatoid arthritis or lymphoma.  While it is known that a small number of lymphoma patients will develop PML regardless of the treatment they undergo, it is not typically seen in anemia or arthritis patients, the researchers said.

According to The Wall street Journal,  doctors at the FDA are trying to determine if long-term, uninterrupted Rituxan therapy may play a role in the development of PML.  The agency has discussed  whether a "drug holiday" - an interruption in therapy - might mitigate the risk of PML, the report said.  But that could be a problem for many lymphoma patient, as a break could lead to a recurrence of the disease that is more difficult to treat.  In such a case, higher doses of Rituxan are needed to bring the cancer under control, the Journal said.

The doctor who led the RADAR study,  Charles Bennett, told the Journal that he believes that Rituxan should only be used for life-threatening ailments like lymphoma until more conclusion can be drawn about its link to PML.  A co-author of the study, Kenneth Carson, is of the opinion that the FDA should consider imposing special prescribing conditions on Rituxan, similar to those imposed on Tysabri, a drug for MS that has been liked to PML.

One thing no one is advocating is the withdrawal of Rituxan from the market because it is often the best option for patients with life-threatening cancer.  However, other drugs have been withdrawn because of associations with PML.  As we reported in April, the psoriasis drug Raptiva was voluntary withdrawn from the market after three patients died from PML.  Tysabri was withdrawn for a time because of its PML link, but reintroduced under current prescribing restrictions.

]]> http://www.yourlawyer.com/articles/read/16575 Wed, 20 May 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16575 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 ((Research on Adverse Drug Events and Reports) is an international consortium of physicians that collaborate to identify adverse reactions to medications and devices.

According to Science Daily, Rituxan is the most important and widely used cancer drug for lymphoma, and is also approved as a therapy for rheumatoid arthritis. In addition, Rituxan is also used off-label to treat multiple sclerosis, lupus erythematosus and autoimmune anemias.

Last September, the labeling for Rituxan was updated to reflect its association with PML. At the time, the Food & Drug Administration (FDA) said that at least two patients given Rituxan as a treatment for systemic lupus erythematosus had died from PML.

PML is a viral infection that affects the white matter of the brain.  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.

According to Science Daily,  the 57 Rituxan PML patients identified in  the RADAR study were using the drug as a treatment for anemia, rheumatoid arthritis or lymphoma.  On average, they died just two months after being diagnosed.  While it is known that a small number of lymphoma patients will develop PML  regardless the treatment they undergo, it is not typically seen in anemia or arthritis patients, Science Daily said.

In many cases, the researchers found that PML patients taking Rituxan were misdiagnosed with disease like dementia and Alzheimer's, Science Daily said.  

The head of  the RADAR project told Science Daily that considering the study's findings, there is a  need for caution in prescribing Rituxan.  "The drug has tremendous usefulness in lymphoma, but as its use expands to diseases that are not cancer, we might have to reconsider the risk benefit," Charles Bennett, M.D said. "Some cancer patients take this drug chronically for non-fatal chronic leukemia where the risk-benefit calculations differ from lymphoma."

Bennett told Science Daily that the next step in RADAR's research will be to determine what risk factors might be linked to Rituxan-associated PML.  

]]> http://www.yourlawyer.com/articles/read/15120 Thu, 11 Sep 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/15120 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  arthritis.  In addition to rheumatoid arthritis, Rituxan is approved to treat non-Hodgkins Lymphoma.

PML is characterized by the progressive inflammation of the brain and central nervous system. 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.

PML  is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply.

Rituxan is a powerful medication that suppresses the immune system. In February 2006, the labeling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML. The FDA also cautioned physicians who were considering treating a patient with Rituxan for any condition to inform the patient of the risk of developing PML.

Last year, the FDA warned that two patients taking Rituxan off-label for systemic lupus erythematosus had died from PML.  

This latest PML-Rituxan fatality involved a woman taking the drug for rheumatoid arthritis. According to the FDA, the patient was undergoing chemotherapy and radiation treatment for cancer in the months before she developed the infection.  The agency said the patient  received Rituxan in a long-term safety extension clinical study. According to the FDA, the patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan.

In a letter sent to healthcare providers, Genentech and Biogen Idec, the makers of Rituxan, advised doctors to consider PML in any patient presenting with new onset neurologic manifestations. Consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated. Rituxan should be discontinued immediately in patients who develop PML, the letter said.

Ritixan is not the only Biogen Idec drug to be associated with PML.   Earlier this summer, the FDA warned that the same brain disease had been associated with Tysabri, a drug for multiple sclerosis (MS) that Biogen Idec markets in a joint effort with Elan Inc.  The FDA warning was prompted by reports of two European MS patients undergoing Tysabri monotherapy had developed PML.

In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical  trials developed PML.  But the drug was reapproved in 2006, although it was subject to restrictions. The new European cases of Tysabri-related PML raised alarms because both patients had been taking Tysabri as monotherapy - with no other drugs. It had been theorized that patients contracting PML had done so because of exposure to multiple medications and that monotherapy with Tysabri was less risky.

]]> http://www.yourlawyer.com/articles/read/13008 Tue, 14 Aug 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13008 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 approved to treat SLE.  The FDA has only approved Rituxan for the treatment of non-Hodgkin’s lymphoma and for rheumatoid arthritis when other treatments have failed.  Despite the fact that Rituxan is not approved to treat SLE, the FDA estimates that as many as 10,000 SLE patients have received this treatment.

When a drug is prescribed for a condition that it is not approved to treat, this is known as “off-label use”.   This practice is not rare, nor is it illegal.  Once a drug is approved by the FDA, doctors are free to prescribe it in any way they choose.  Drug companies are forbidden from advertising possible off-labels uses, but if a physician asks for information on off-label treatments, the companies are free to provide it.  Currently, hundreds of prescription drugs are prescribed off-label.  Unfortunately, this means that the safety of these drugs in treating non-approved illnesses was never evaluated.

Rituxan is a powerful medication that suppresses the immune system.  Lupus is an autoimmune disease that occurs when the body's tissues are attacked by its own immune system.  Rituxan is used off-label to suppress the immune systems of SLE patients, thereby easing their lupus systems.  But that could come at a price, because suppressing the immune system also leaves patients open to potentially serious infections, like PML.

PML is characterized by the progressive inflammation of the brain.  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.

Of the two Rituxan-treated patients who died from PML, one was a seventy-year-old woman.  She received six infusions of Rituxan between 2004 and 2005.  Soon after, she developed vertigo, involuntary tongue biting and problems walking.  An MRI confirmed that the patient had PML, and she died in March 2006.  The second patient, a 46-year-old woman, died in July the same year.  She had received Rituxan three times between 2002 and 2005.  Her symptoms became apparent in April 2006.

In February 2006, the labeling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML. The FDA also cautioned physicians who were considering treating a patient with Rituxan for any condition to inform the patient of the risk of developing PML.

]]> http://www.yourlawyer.com/articles/read/12402 Tue, 19 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12402
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 from the infection after taking Rituxan, the Food and Drug Administration said in a notice posted on its website.

The two deaths are the first ones reported for so-called off label uses for Rituxan. Doctors often prescribe a drug for diseases other than those for which it is approved if they believe it may help with similar symptoms. Systemic lupus erythematosus, or SLE, is an autoimmune disease that causes arthritis, among other things.

The news comes as Genentech and Biogen seek to expand approved treatments for Rituxan, including lupus. The drug is their biggest seller, with $1.8 billion in sales nationwide last year. It is illegal for drug makers to promote off-label uses, but doctors can use their judgment.

"This might make it more challenging to develop Rituxan" for other diseases, Eric Schmidt, an analyst with Cowen & Co. in New York, told Bloomberg News. "Even though we can't necessarily link this to Rituxan, it's an unfortunate circumstance."

The link between Rituxan and the brain infection, called progressive multifocal leukoencephalopathy, or PML, is not clear, but 23 rheumatoid arthritis and lymphoma patients have contracted the brain illness while or shortly after being treated with Rituxan, Genentech spokeswoman Debra Charlesworth said.

PML usually is fatal, and there is no treatment.

More than a million patients have been treated with Rituxan since the drug was approved in 1997, Charlesworth said.

The virus that causes PML is present in 80% of adults but is dormant, the FDA said. It is not clear whether the virus is triggered by Rituxan, which suppresses a patient's immune system, or by the diseases it is supposed to treat.

Rituxan's prescribing instructions already include information about reports of viral infections, including PML.

Genentech and Biogen estimated that about 10,000 SLE patients were treated with Rituxan.
]]> http://www.yourlawyer.com/articles/read/12401 Tue, 19 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12401
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 with severely compromised immune systems.

Rituxan, which is used to treat non-Hodgkin's lymphoma and rheumatoid arthritis, is not approved to treat lupus. However, such drugs are sometimes prescribed to treat conditions other than those they are approved for, a practice known in the medical industry as "off-label" use. Off-label prescribing is often done for patients who are not responding well to more standard therapies.

"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, in a statement Tuesday.

"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," Galson added.

Based on the antibody rituximab, Rituxan works by manipulating the immune system and belongs to a class of drugs known as immunomodulators. The drug has been on the market since 1997.

This is the second time that Rituxan has been linked to PML, a condition generally seen in patients with advanced AIDS. In February of this year, the drug's label was changed to advise physicians that cases of PML had been observed in patients taking Rituxan for lymphoma. A majority of the patients affected had also taken other immunomodulators, according to the FDA.

The agency also noted that PML has been seen in lupus patients who had taken immunomodulator drugs other than Rituxan.
Rituxan, which had 2005 sales of $1.8 billion, was developed by Genentech and Idec, a predecessor of Biogen Idec. The drug is Biogen's biggest revenue driver next to its popular multiple sclerosis therapy Avonex.

In early 2005, Biogen was hit hard when it discovered that its newly-launched multiple sclerosis drug, Tysabri, had been linked with three cases of PML. Like Rituxan, Tysabri is also an immunomodulator. In the three PML cases associated with Tysabri, the patients were found to have also taken other immunomodulators, such as Biogen's Avonex.

Tysabri was put back on the back earlier this year, with a warning against using the drug with other immunomodulator drugs.]]> http://www.yourlawyer.com/articles/read/12406 Tue, 19 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12406
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 patients with CD20-positive, B-cell, non-Hodgkin's lymphoma and for rheumatoid arthritis that has become refractory to standard therapies. Yet the FDA noted that Rituxan is prescribed off-label for SLE and other serious conditions.

Symptoms of PML include major changes in vision, balance, or coordination, or confusion, said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. He said patients who are using Rituxan, or who have used it, should consult a physician if they have any of those symptoms.

The FDA updated the Rituxan label last February to include post-marketing reports of serious viral illnesses, including PML, in patients with lymphoma who were treated with Rituxan.

There have been 23 confirmed cases of PML in patients with lymphoid malignancies either during or after treatment with Rituxan. But the FDA said most of those patients had also been treated with other drugs known to affect the immune system.

Additionally, PML has occurred in patients who have not received Rituxan. Most reports have been in patients with a compromised immune system, either from 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.

The FDA said it is working with Genentech to add this recent information on PML to the drug label.

Additionally, Biogen Idec, which co-markets Rituxan with Genentech, said that the companies jointly issued a letter to physicians informing them of the two deaths.]]> http://www.yourlawyer.com/articles/read/12405 Tue, 19 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12405
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 information and adverse event reporting program. The drug manufacturers estimate that approximately 10,000 patients with SLE have received rituximab therapy.

PML is a rare and frequently fatal demyelinating disease of the central nervous system that primarily affects patients whose immune systems are compromised by disease or medical treatments. It is caused by reactivation of the JC virus, which remains latent in up to 80% of healthy adults. There are no known effective treatments for PML.

The first death occurred during March 2006 in a woman aged 70 years with a history of lupus nephritis and hemolytic anemia. She had received prior treatment with cyclophosphamide, azathioprine, and long-term corticosteroid therapy. After receiving multiple infusions of rituximab (4 in 2004 and 2 in 2005), she developed vertigo, tongue biting, and difficulty walking. Magnetic resonance imaging (MRI) revealed multiple brain lesions, and brain autopsy showed characteristics of PML.

The second death, in July 2006, involved a woman aged 45 years with a 24-year history of SLE and prior treatment with cyclophosphamide and intravenous methylprednisolone. After receiving 3 courses of rituximab from 2002 to 2005, she developed neurologic signs and symptoms. MRI revealed multiple brain lesions, and tests of cerebrospinal fluid were positive for JC virus.

Because rituximab targets CD20-positive lymphocytes, its use is associated with an increased vulnerability to infection regardless of the indication. Postmarketing reports of serious viral illness have included 23 confirmed cases of PML in patients with lymphoid malignancies either during treatment or as long as 1 year after the last dose. The FDA notes that the majority of affected patients had also received other immunosuppressive drugs.

Healthcare professionals are advised to maintain a high index of suspicion for PML in patients receiving rituximab therapy, particularly those who develop new neurologic signs or symptoms.

Patients receiving rituximab therapy should be advised to promptly contact their healthcare professional if they develop any major changes in vision, balance/coordination, or experience disorientation/confusion.

Rituximab intravenous infusion is approved for use in combination with methotrexate to reduce signs and symptoms of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to one or more tumor necrosis factor–alpha inhibitor therapies.

It is also indicated for use with cyclophosphamide, vincristine, and prednisolone chemotherapy in the first-line treatment of follicular, CD20-positive B-cell non-Hodgkin's lymphoma (NHL), and for the treatment of low-grade NHL in patients with stable disease who achieve a partial or complete response to first-line treatment with CVP chemotherapy.

In addition, rituximab can be used for the treatment of patients with relapsed or refractory low-grade or follicular CD20-positive B-cell NHL, and for the first-line treatment of CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone or other anthracycline-based chemotherapy regimens.
]]> http://www.yourlawyer.com/articles/read/12403 Tue, 19 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12403
The FDA said it has recently learned of two deaths from progresive multifocal leukoencephalopathy (PML) in patients treated with Rituxan, a drug developed in San Diego by Idec Pharmaceuticals, now merged with Biogen to form Cambridge-based Biogen Idec.

The patients were given Rituxan, for systematic lupus erythematosus, or SLE. Rituxan is not approved to treat this disease. Rituxan is approved for treatment of non-Hodgkin's lymphoma and rheumatoid arthritis. Biogen Idec sells Rituxan in partnership with South San Francisco-based Genentech Inc.

Last year, Genentech suspended sales of another drug, Tysabri, due to reports that two patients taking the drug for multiple sclerosis had contracted PML. The FDA later allowed Tysabri sales to resume, with additional cautionary warnings. Genentech has built a manufacturing plant in Oceanside to make Tysabri. The plant is expected to begin commercial production next year.

Both Rituxan and Avastin belong to a class of drugs called monoclonal antibodies, which are specifically crafted to destroy cells implicated in disease. FDA spokeswoman Karen Riley said she had not heard of anything to suggest a linkage between the reactions.]]> http://www.yourlawyer.com/articles/read/12397 Mon, 18 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12397
Rituxan is a powerful immunosuppressant that eliminates mature circulating B-cells for up to nine months. Rituxan is approved for CD20-positive, B-cell, non-Hodgkins lymphoma and for moderately-to severely-active rheumatoid arthritis when there has been inadequate response to other treatments. Rituxan is being studied for other indications, and is prescribed off-label for other serious diseases and conditions such as SLE. The sponsor estimates that approximately 10,000 patients with SLE have been treated with Rituxan. Reactivation or exacerbation of viral infections including JC virus leading to PML may occur when patients receive Rituxan for any reason. FDA is working with the sponsor to gather additional information about the occurrence of PML in patients treated with Rituxan and to strengthen the Warnings about the risk of PML in the product labeling for Rituxan. Patients who have been treated with Rituxan and present or develop new neurological signs or symptoms should be evaluated for PML.
]]> http://www.yourlawyer.com/articles/read/12396 Mon, 18 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12396
The signs of PML include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems.  Recognition of these warning signs of PML may be obscured by the fact that they are also associated with the underlying diseases for which Rituxan may be prescribed.

• Patients who have been treated with Rituxan should contact their doctor if they experience any warning signs like those listed above to find out the exact cause of their warning signs and to be checked for PML.
• Physicians who are thinking about treating a patient with Rituxan for any condition should inform their patient about the chance of PML with Rituxan treatment because there is no known effective treatment for PML.
• Patients who are taking or are considering taking Rituxan should be aware of the chance of developing PML and discuss it with their doctor.

Rituxan is a powerful medication that is used to suppress the immune system.  It works by blocking the effect of specific immune cells in the blood, known as B cells, for up to six to nine months.  Rituxan is approved for use only in patients with certain types of cancer called non-Hodgkin’s lymphoma and for rheumatoid arthritis when other treatments have failed.  Rituxan is not approved for the treatment of SLE.  The sponsor estimates that approximately 10,000 patients with SLE have been treated with Rituxan.

In February 2006, the labeling for Rituxan was updated to include information about reports of several different types of viral infections, including PML, that had become active again or worsened in cancer patients taking Rituxan.  FDA is working to gather more information about Rituxan and PML and to strengthen the Warnings about PML in the Rituxan product label.
]]> http://www.yourlawyer.com/articles/read/12400 Mon, 18 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12400
The Food and Drug Administration said it plans to add more warnings to the drug's label on the risk of potentially deadly viral brain side effects. According to FDA, Rituxan reactivated latent JC virus in the two patients who died while taking the drug. Nearly 80 percent of adults have latent JC virus, according to FDA.

Genentech and Biogen Idec Inc., which developed the drug comarketed by Genentech, on Monday sent a letter to physicians and prescribers informing them of two deaths from progressive multifocal leuklencephalopathy, a rare nervous system condition, in patients taking Rituxan. The patients were taking Rituxan for Systemic Lupus Erythematosus, a use for which it is not approved.

In a statement posted on its web site today, the FDA advised physicians to "maintain a high index of suspicion for the development" of the brain virus in patients taking Rituxan.

FDA said it plans to continue gathering more data on the drug and will update its web site with additional advisories.

Genentech reported sales of $1.8 billion for Rituxan last year.]]> http://www.yourlawyer.com/articles/read/12398 Mon, 18 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12398 ]]> http://www.yourlawyer.com/articles/read/12404 Mon, 18 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12404
While the drug is approved for treatment of non-Hodgkin’s lymphoma and rheumatoid arthritis, both of the patients who died were being treated for systemic lupus erythematosus (SLE), a condition for which Rituxan has not been approved.

“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.”

According to the FDA, “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 FDA has asked Genentech, the drug’s manufacturer, to update its label warning information. In 2005, sales of Rituxan reached $1.8 billion.
]]> http://www.yourlawyer.com/topics/overview/rituxan Mon, 18 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/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.]]>