CellCept and Myfortic are both the brand names of the same generic drug made and sold by different drug companies. Either one can be given to a patient undergoing an organ transplant to reduce the risk that the body will reject the new organ. In use in the U.S. since the 1990s, CellCept and Myfortic are important drugs used to help transplants be more successful, but they are not always safe.
Since the drugs have been on the market, trial data and reports have found that they can cause serious side effects including conditions like pure red cell aplasia and progressive multifocal leukoencephalopathy. It can also lead to infections, which may be serious. Most importantly of all, thought, CellCept has been found to increase the risk of birth defects when taken during pregnancy. This may lead to lawsuits in the future as more women suffer the effects of having used the drug while pregnant.
What is CellCept?
The generic drug that is sold under the names CellCept and Myfortic is mycophenolic acid or mycophenolate. The compound was first discovered more than 100 years ago and was believed to work as an antibiotic and antifungal. It was forgotten for decades when finally it was developed in a clinical form and tested by researchers in South Africa in the 1970s.
The U.S. Food and Drug Administration (FDA) first approved the use of mycophenolic acid in 1995. CellCept is manufactured and sold by Roche, while Myfortic, a slightly different form of the drug, is made and sold by Novartis. Roche owns a partial stake in Novartis. Both drugs are immunosuppressant medications given to transplant patients.
CellCept was approved by the FDA for use in patients who are receiving heart, liver, or kidney transplants. It is supposed to be used in conjunction with other drugs including corticosteroids and cyclosporine. CellCept can be taken as a tablet or an oral suspension, but can also be given as an intravenous injection. CellCept is contraindicated for people with certain allergies.
Myfortic is indicated for use in patients receiving kidney transplants. It can be given to children over five years old at least six months after the completion of the transplant. It is available as capsules and tablets, although these cannot be used interchangeably. As with CellCept, Myfortic is not to be used in patients with certain allergies and is used along with cyclosporine and corticosteroids.
How it Works
The reason that mycophenolic acid is used in patients with transplants is to increase the odds of it being successful. When a person receives a new organ the immune system is likely to attack it because it senses it as a foreign pathogen. Mycophenolic acid is an immunosuppressant, which means it suppresses or minimizes the action of the immune system. This helps to ensure that the body will not reject the organ.
The most common side effects of CellCept are high blood pressure, edema, or swelling, of the feet, ankles, and lower legs, stomach pain and general pain, vomiting, and diarrhea. In children the most common side effects include stomach pain, infections, fever, vomiting, diarrhea, low white and red blood cell counts, high blood pressure, and sore throat.
Serious side effects that should be reported immediately and may require emergency treatment include diarrhea, edema, chest pains, trouble breathing, a rash or itchy skin, fatigue, dizziness, fainting, pale skin, bloody or tarry stools, bloody vomit, and yellowing of the eyes or skin.
Pure Red Cell Aplasia
Taking a drug like CellCept, which suppresses the immune system, comes with a lot of risks. Many of the side effects are mild and not serious, but some are severe, dangerous, and possibly life threatening. In 2009 Roche reported to the FDA that there were cases of pure red cell aplasia in some users of the drug. This is a type of anemia characterized by too few blood cells and causes fatigue, pale skin, and lethargy. Cessation of the drug helps, but patients may not be able to stop using CellCept without compromising the transplant.
Progressive Multifocal Leukoencephalopathy
A very serious, possibly fatal infection of the brain called progressive multifocal leukoencephalopathy (PML) can be caused by taking mycophenolic acid. Signs of the infection include unexplained apathy, confusion, trouble thinking, loss of muscle control, and weakness on one side of the body. This must be reported immediately for treatment or it can be life-threatening.
PML is a particularly risky type of infection, but mycophenolic acid can result in any number of other infections, because it weakens the immune system’s ability to fight off pathogens. People on CellCept or Myfortic are at risk for fungal infections, yeast infections, and viral infections including shingles and herpes. Patients are also at risk for infection by the BK virus, which can cause kidney failure, cytomegalovirus infections, which can cause a serious blood infection, and hepatitis B and C viruses.
There are many potential risks associated with taking mycophenolic acid, but the most troubling may be the potential for birth defects or miscarriages when women take the drug during pregnancy. Adverse events reports and trial data have shown that women who take mycophenolic acid during the first trimester are at a higher risk for having a miscarriage and for delivering a baby with birth defects.
Women who may become pregnant while taking these drugs are encouraged to use birth control while on them and for a full six weeks after ceasing use of them. CellCept may interfere with hormones in birth control pills and make them less effective, so two methods should be used. Women must also take at least two pregnancy tests before beginning CellCept or Myfortic.
The FDA considers the risk of birth defects and miscarriage to be serious enough to warrant a special black box warning. This type of warning is reserved for the most dangerous of all side effects. The FDA has a special registry for women taking mycophenolate who become pregnant. The purpose is to collect more information about what happens when women become pregnant while taking the medication.
Studies have confirmed that mycophenolic acid does increase the risk of birth defects and miscarriages, but this information did not come to light until the drug had been on the market for years. Many women have reported having miscarriages and children born with defects and they feel as if they were not adequately warned. It may eventually be proven that Roche or Novartis knew of the risks and did not communicate them. If this is true they could be facing individual lawsuits, class action suit, federal and state lawsuits, as well as fines.
The drug companies have already been found guilty of using kickbacks to promote and sell more CellCept and Myfortic. Novartis was forced to pay $3.35 billion in fines because of this unethical and illegal practice. Lawyers are now evaluating the potential for cases against the companies for women who suffered from taking CellCept or Myfortic while pregnant. If you had a miscarriage or a child born with defects, you may be able to make a case against Novartis or Roche and get the compensation you deserve.