CellCept is an immunosuppressant drug that prevents the body’s immune system from attacking a transplanted organ. It is used for solid organ transplants such as kidneys, livers and hearts. This drug works by preventing white blood cells and lymphocytes from attacking foreign cells that are present in the body due to a transplant. The white blood cell’s job is to destroy foreign cells, which is the opposite of what doctors want when a patient has had an organ transplant. Doctors have also prescribed CellCept to treat autoimmune diseases where a patient’s immune system is overactive. CellCept was approved by the FDA in 1995.

Although this drug serves a necessary purpose, a patient taking an immunosuppressant may be at risk to contract different infections and microbe attacks. This drug has been linked to lymphoma, opportunistic infections and sepsis.

Lymphoma and progressive multifocal leukoencephalopathy (PML) have been linked to the use of CellCept. Both of these diseases are often fatal and can cause irreversible nerve damage and disability. The body is more prone to such diseases when taking CellCept because the immune system has been weakened.

In 2007, the FDA updated the label for CellCept. The label currently warns doctors and patients about the dangers of taking the drug while pregnant. In a study conducted by the National Transplantation Pregnancy Registry, it was concluded that pregnant women taking CellCept had a significantly higher risk of miscarriage during the first trimester. It also warned of the risk of babies being born with birth defects such as external ear and facial abnormalities—cleft lip and palate, and problems with distal limbs, esophagus and kidneys.

CellCept is classified as a Category D drug (Positive Evidence of Fetal Risk). Doctors are advised to warn women of childbearing age about the fetal risks of taking CellCept, and the birth defects are so severe that women are advised to use two forms of birth control while taking the drug. Women must also be warned about how CellCept can affect oral contraceptives and must explore all the options of birth control.

Women must undergo a pregnancy test within one week of beginning CellCept, and have been advised to start contraceptives four weeks before the start of the medication. The label also advises that women planning on getting pregnant should not be prescribed CellCept unless other immunosuppressant drugs have not been successful.

Serious side effects may include:

  • Fever, chills, body aches, flu symptoms
  • Pale skin, easy bruising or bleeding, unusual weakness, trouble breathing, fast heart rate
  • Coughing up blood or vomit that looks like coffee grounds
  • Bloody, black, or tarry stools
  • Painful or difficult urination
  • Chest pain
  • Feeling faint
  • Problems with vision, speech, balance, or memory
  • Weakness in your legs, lack of coordination

Less serious side effects may include:

  • Nausea, vomiting, stomach pain, diarrhea, or constipation
  • Headache, mild weakness
  • Swelling in your hands or feet
  • Numbness or tingly feeling
  • Anxiety, sleep problems (insomnia)
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