Product News and Recalls

CellCept and Myfortic injuring children and adults

On 5/16/2008 the FDA issued an alert for users of the immunosuppresants Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic). These drugs are commonly prescribed after organ transplants to prevent organ rejection, and have also been prescribed for immunemediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme.


These medications have led to reports of infants born with serious birth defects, including microtia (deformity of the outer ear) and cleft lip and palate. Other instances of internal deformities (incomplete heart, intestines) and external deformities (oversized hands, feet, jaw) have also been reported.

These drugs also increase the risk of spontaneous abortion in the first trimester.

The labeling for both drugs was revised in November 2007 to change the Pregnancy Category to “D”: positive evidence of human fetal risk, but potential benefits may warrant use of the drug in pregnant women despite the potential risk. The risks of early pregnancy loss and congenital malformations were also added to the Boxed Warning and Warnings sections of the labels. Dear Healthcare Professional Letters were sent to prescribing physicians.

Currently, the FDA requires clinicians who intend to prescribe these drugs to confirm that female patients are not pregnant, to warn patients of the risk of fetal harm, and to provide counseling about contraceptives (as it is recommended that women of childbearing potential must use two effective forms of birth control).

In the National Transplantation Pregnancy Registry (NTPR) there were data on 33 MMF-exposed pregnancies in 24 transplant patients. There were 15 spontaneous abortions (45%). Of 18 live-born infants, 4 of them infants had structural malformations (22%). Compare this to the background rate for congenital anomalies in the United States of 3%, and to NTPR data showing a rate of 4-5% among babies born to organ transplant patients using other immunosuppressive drugs.

In postmarketing data (collected worldwide, 1995-2007) on 77 women exposed to systemic MMF during pregnancy, 25 had spontaneous abortions and 14 had a malformed infant or fetus. Overall, 6 of 14 malformed offspring had ear abnormalities.


More recently, it has also been determined that Mycophenolate Mofetil and Mycophenolic Acid can cause progressive multifocal leukoencephalopathy (PML), a life-threatening disorder that affects the central nervous system. When it occurs, it is usually in patients with immune systems suppressed by disease or medicines. It activates the polyomavirus, also known as the JC virus, something that is found in most adults but does not usually cause symptoms. The activated JC virus attacks the cells that make myelin, the protective coating around nerve cells, and leads to nerve damage. Signs and symptoms of PML can include vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs. Many people who develop PML die. Patients who survive may be permanently disabled due to irreversible nerve damage.

The manufacturer of CellCept, Roche Pharmaceuticals, informed the FDA of the possible connection between CellCept and PML on November 8, 2007. Roche issued a Dear Healthcare Professional Letter in Europe on February 18, 2008. The FDA, always quick to respond, issued Dear Healthcare Professional Letters on May 29, 2008.

If you have taken CellCept or Myfortic, contact Lopez McHugh, LLP for a free consultation at 877-737-8525.