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CellCept Side Effects May Be Linked To Birth Defects Lawsuits

CellCept | Lawsuits, Lawyers | Side Effects: Miscarriage, Birth Defects, Lymphoma, Malignancies, Infections, Sepsis, Facial Abnormalities, Cleft Palate, Distal Limbs, Esophagus, Kidney

CellCept Birth Defects

In October 2007, the labeling for CellCept was updated to include a boxed warning about its potential to cause miscarriages and birth defects. The concern about these side-effects was so great that the Food & Drug Administration (FDA) actually warned women of childbearing age to use two methods of birth control before, during and after treatment with CellCept.

CellCept, also known by its generic name mycophenolate mofetil, is part of a class of drugs called immunosuppressants. It was approved in 1995 to prevent rejection of solid organ transplants, including kidney, heart and liver. When used in combination with cyclosporine and corticosteroids, CellCept can greatly reduce the chance that a patient's immune system will attack a transplanted organ. However, like all immunosuppressant drugs, CellCept does carry certain risks, including the development of lymphoma and other malignancies. Like other drugs in its class, CellCept is also linked to an increased risk of developing opportunistic infections and sepsis.

CellCept Linked to Increased Risk of Birth Defects, Miscarriage

In October 2007, the FDA announced that an analysis of data regarding CellCept from the National Transplantation Pregnancy Registry led it to conclude that pregnant women taking CellCept had a significantly higher risk of miscarriage during the first trimester, and that their babies are more likely to develop birth defects, including external ear and facial abnormalities such as cleft palate and lip, and problems with the distal limbs, esophagus and kidney.

CellCept Label Changed to Include Warnings on Miscarriage, Birth Defects

While it was known previously that CellCept could cause problems during pregnancy, the FDA had classified the risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new CellCept labeling now classified the miscarriage and birth defect risk as Category D (Positive Evidence of Fetal Risk). The new CellCept label advises that doctors should warn female patients of childbearing age of the CellCept miscarriage and birth defect risks. It also said that women of childbearing age who receive CellCept must be counseled on contraceptive use, and they should be made aware that the drug can interfere with the effectiveness of oral contraceptives.

The FDA also required women of childbearing age to undergo pregnancy testing within one week of beginning CellCept therapy. The label also said that female patients prescribed CellCept should begin using contraceptives four weeks prior to starting the drug, and should continue doing so for six weeks after treatment with CellCept was ended. The new CellCept label also advised that these patients should use two methods of birth control while taking CellCept. Finally, the new warning advised that a woman planning a pregnancy should not be prescribed CellCept unless other immunosuppressant drugs proved to be unsuccessful in treating organ rejection.

Need Legal Help Regarding CellCept Side Effects?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).



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Canadian Health Agency Warns that Anti-rejection Drugs Cause Birth Defects

Jan 19, 2016
Health Canada, Canada's health regulatory agency, warns that the organ anti-rejection drugs CellCept (mycophenolate mofetil) and Myfortic (mycophenolate sodium) can cause miscarriage and congenital malformations following exposure during pregnancy. The agency warns about use of the drugs: during pregnancy due to their mutagenic (changing the DNA) and teratogenic (interfering with the development of the fetus) potential by women of childbearing potential who are not using highly...

CellCept Associated with Anemia

Aug 14, 2009 | Parker Waichman LLP
CellCept has been associated with a severe type of anemia, the Food & Drug Administration (FDA) warned today. CellCept's label has been revised to warn doctors about the condition, called pure red cell aplasia (PRCA).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  with cyclosporine and...

CellCept, Other Organ Rejection Drugs Tied to Opportunistic Infections

Jul 14, 2009 | Parker Waichman LLP
Labels for the drugs CellCept, Rapamune, Myfortic, Sandimmune and Neoral are being updated to reflect a higher risk of  opportunistic infections, including  BK virus-associated nephropathy (kidney damage). The drugs are given to transplant patients to prevent organ rejection.According to a statement on the Food & Drug Administration's (FDA) website, the decision to update the labeling for CellCept, Rapamune and the other drugs followed an analyses of its Adverse Event Reporting...

CellCept Label Changed to Reflect Risk of PML

Jun 30, 2008 | Parker Waichman LLP
The maker of CellCept, Swiss Drug Maker Roche, has informed healthcare providers that it has modified the "Warnings" and "Adverse Reactions" sections of the CellCept prescribing information to include information on its association with several cases of Progressive Multifocal Leukoencephalopathy (PML). 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,...

FDA Reposts CellCept Warning, Pregnancy-Organ Transplant Drug Risk Link

May 22, 2008 | Parker Waichman LLP
The Food and Drug Administration (FDA) Friday reposted an earlier notice warning that Swiss drug makers Roche and Novartis drugs prescribed for organ transplant recipients could cause miscarriages and birth defects when taken by pregnant women.  The FDA also urged doctors to confirm that transplant patients are not pregnant and are using effective contraception, according to AP/  Roche's CellCept and Novartis' Myfortic are used to help the body avoid rejection following...

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