Parker Waichman LLP

CellCept Linked to Fatal Neurological Disease

Last November, Swiss drug maker Roche alerted the US Food and Drug Administration (FDA) about reports of a neurological disease—progressive multi-focal leukoencephalopathy—that is often fatal, occurring in patients taking its drug <“https://www.yourlawyer.com/topics/overview/cellcept_miscarriage_birth_defects”>CellCept. CellCept is used to help the body avoid rejection following organ transplantation. Now, regulators trying to determine whether organ transplant drugs made by […]

Last November, Swiss drug maker Roche alerted the US Food and Drug Administration (FDA) about reports of a neurological disease—progressive multi-focal leukoencephalopathy—that is often fatal, occurring in patients taking its drug <“https://www.yourlawyer.com/topics/overview/cellcept_miscarriage_birth_defects”>CellCept. CellCept is used to help the body avoid rejection following organ transplantation. Now, regulators trying to determine whether organ transplant drugs made by Roche and Novartis increase the risk of the often-fatal disease. The FDA also said today that it is reviewing similar risks with Myfortic, a drug made by another Swiss drug maker—Novartis—that is used to prevent kidney transplant rejection.

CellCept—generically known as mycophenolate mofetil—is part of a class of drugs called immunosuppressants and was approved in 1995 to prevent rejection of solid organ transplants, including kidney, heart, and liver. When CellCept is used in with cyclosporine and corticosteroids, it greatly reduces the patient’s immune system from attacking the transplanted organ. As with all immunosuppressants, CellCept carries certain risks, including development of lymphoma and other malignancies and is also linked to an increased risk of developing opportunistic infections and sepsis.

The FDA announced the process to review the reports and consider revised labeling for the medications takes approximately two months. Until then, regulators advise doctors and patients to watch for neurological symptoms. Progressive multi-focal leukoencephalopathy attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. According to the FDA, patients who the disease are often permanently disabled.

Christopher Vancheri, a Roche company spokesman, confirmed 10 cases of progressive multi-focal leukoencephalopathy in CellCept patients, adding that over 500,000 patients have used CellCept since 1995, when it was approved in the US.

Last October, CellCept was linked to miscarriage and birth defects, prompting the FDA to add a new boxed warning to its label last November. That labeling remains under FDA review. The potential for side effects was considered so great that the FDA advised women of childbearing age to use two methods of birth control before, during, and after CellCept treatment. Meanwhile, European regulators added language about the neurological disease to CellCept packaging and, this February, Roche sent a letter to European doctors, highlighting the labeling changes. The letter stated problems were reported in kidney, heart, and lung transplant patients and the neurological disorder was seen in patients taking the drug for a form of lupus, a CellCept use not approved by regulators.

Roche said it is difficult to sort out the role of its drug in the reports since many patients had other diseases and were taking other drugs. According to the Roche letter—which the FDA posted to its Website today, determining the role of the drug in the reports poses some challenges because many patients taking the drug were suffering with other illnesses and also on other drugs, “However, the contributory role of CellCept cannot be excluded.”

A spokeswoman for Novartis said the company is not aware of any instances of the neurological disease in patients taking its drug and plans to cooperate with any labeling changes recommended by regulators.

Progressive multi-focal leukoencephalopathy is associated with at least one other drug, Tysabri, which is used to treat multiple sclerosis. Tysabri was actually removed from the market in 2005 because several patients taking it had died of the disorder.  In 2005, the law firm of Parker Waichman filed suit against Elan Inc. and Biogen Idec, the makers of Tysabri, on behalf of a woman who died from progressive multi-focal leukoencephalopathy while taking that drug.  When contacted, Jerry Parker, the managing partner of Parker Waichman said that Tysabri case had been resolved, but that the resolution remained confidential.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I am very happy with the way Parker and Waichman is proceeding with my lawsuit. They clearly guided me through the process and answered all of my questions. One of the the things that I like the most about their administration is that they let you know right from the getgo, that before they making a decision, they need to study all possibilities of how to win the case, and that gave me the confidence assuring me that I made the right choice to hire Parker and Waichman. They have assigned Josephine Burgess to my case and I am impressed of how quickly she answer all my questions as well as helping me to promptly expedite my case, it is very ez to go through it with your help. Thank you Ms. Burgess because of your professionalism I understand that Parker and Waichman have an excellent team.
Miguel Boitel
5 years ago
5 Star Reviews 150
Jill was great she took care of me the best alway call to check up on me,great law firm
Trapt Genres
6 years ago
5 Star Reviews 150
I am very pleased with the outcome of the case. I will never be hesitant to recommend your firm.
Marian Hampton
8 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038