FDA Strengthens warning for CellCept

The following warning was posted by the FDA.

CellCept (mycophenolate mofetil) August 2009
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

[Posted 08/14/2009] Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

See the Drug warning issued by Roche Laboratories Inc.

See CellCept Prescribing Information, revised.

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Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept®

I've been taking CellCept (MMF) daily since my lung transplant seven years ago. How much the generic version will reduce the cost of MMF remains to be seen.

PITTSBURGH, May 7 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Mycophenolate Mofetil Tablets, 500 mg, and Mycophenolate Mofetil Capsules, 250 mg.

Mycophenolate Mofetil is the generic name for Roche's CellCept®, which is indicated for the prevention of organ rejection in patients receiving kidney, heart or liver transplants. CellCept Tablets, 500 mg, and CellCept Capsules, 250 mg, had annual U.S. sales of approximately $680 million and $367 million, respectively, for the 12 months ending March 31, 2009, according to IMS Health. Mylan has commenced shipping both products.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit http://www.mylan.com.

SOURCE: Mylan Inc.

Web site: http://www.mylan.com.

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US regulators warn doctors of organ transplant drug's risks to pregnant women

Here is a further warning about the anti-rejection drug CellCept and it's potential to cause miscarriages and birth defects when used by pregnant women. See my post last month about patients who developed rare neurological problems while taking the drug.

From the International Herald Tribune:

WASHINGTON: Health regulators reiterated their warning Friday that organ transplant drugs from Roche and Novartis can cause miscarriages and birth defects when used by pregnant women.

The Food and Drug Administration previously said it received reports of miscarriages and infants born with ear and mouth birth defects after their mothers had taken Roche's CellCept.

FDA added its most serious warning to CellCept and a similar Novartis AG drug, Myfortic, last October, noting they can cause miscarriage and other serious problems when used by pregnant women. The drug is used to suppress the body's immune system to avoid organ rejection in transplant patients.

In a notice to physicians posted online Friday, the FDA recommended "confirming that a pregnancy has not occurred and ensuring that patients use effective contraceptive measures."

FDA said most of the reported problems came from mothers who were taking the drug before their pregnancies were detected. Some of the patients were taking the drugs for conditions they are not approved to treat, including rheumatoid arthritis and lupus.

A spokesman for Roche said it has not received new reports of miscarriages or birth defects since updating the drug's labeling. The company previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007.

The agency said it will continue working with Roche and Novartis to reduce use of the drugs by pregnant women.

Friday's FDA warning was the second in less than two months for CellCept, which was Roche's sixth best-selling drug last year with sales of nearly $2 billion (€1.3 billion).

The FDA said Last month it was investigating 16 patients who developed rare neurological problems while taking the drug.

The disease, known as progressive multifocal leukoencephalopathy, attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination and memory loss. Patients who survive are often permanently disabled, according to the FDA.

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CellCept Linked to Fatal Neurological Disease

This caught my attention because I have been taking CellCept since my lung transplant six years ago. I'm not overly alarmed because just about every drug I take has potentially harmful side effects and Roche says that there have been only 10 cases of progressive multi-focal leukoencephalopathy reported in the half-million patients who have been on CellCept since 1995. I'm betting on being one of the lucky ones who do not experience this side effect.

From NEWSInferno.com:

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 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 Alonso 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.

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