Research shows the immunosuppressant mycophenalate motefil—sold under the brand name CellCept—causes pregnant female users to miscarry or to give birth to children with disfiguring birth defects, the neurological disorder Progressive Multifocal Leukoencephalopy, and a type of anemia known as Pure Red Cell Aplasia.
What Is CellCept? When Is It Prescribed?
CellCept, the brand name for mycophenalate motefil, is made and sold by Swiss pharmaceutical giant Hoffman-La Roche for solid organ transplants, including kidneys, livers, and hearts. It is an immunosuppressant drug, meaning it prevents a person’s immune system from attacking transplanted organs. CellCept works by preventing certain white blood cells, lymphocytes, from targeting foreign cells from a transplanted organ for destruction. At the same time, it does not inhibit other white blood cells from protecting the body; any immunosuppressant will reduce the ability of users’ bodies to protect them from microbe attacks, however. CellCept can also treat autoimmune diseases in which a person’s immune system is overactive.
The U.S. Food and Drug Administration (FDA) approved CellCept in May 1995 in the form of 250mg oral capsules. It is often prescribed in conjunction with cyclosporine and corticosteroids. As with other immunosuppressants, CellCept is known to cause lymphoma, opportunistic infections, and sepsis.
Hoffman-La Roche has found much success selling CellCept; however, controversies over CellCept’s dangerous side effects have shaken consumer confidence in the drug.
CellCept Might Cause Birth Defects
CellCept causes a few life-threatening side effects. Most importantly, in November 2007, the FDA issued a “black box” CellCept warning on the drug’s packaging alerting users that it causes first trimester miscarriages and birth defects. Specific birth defects include:
- cleft palate
- cleft lip
- ear deformities
Based on data from the National Transplantation Pregnancy Registry, the FDA reclassified CellCept from Category C (“risk of fetal harm cannot be ruled out”) to Category D (“positive evidence of fetal risk, but potential benefits may warrant use of the drug in pregnant women despite the potential risk”). The data showed that out of 33 pregnant women who used CellCept, 15 suffered first trimester miscarriages, and 4 of the remaining 18 (22%) children were born with the above birth defects. In contrast to the 22% deformities rate, 4-5% of children born to women taking other immunosuppressants.
Healthcare professionals were instructed to tell female patients to use two types of birth control and that CellCept can interfere with oral contraceptives. The FDA also required that women begin using contraceptives four weeks before going on CellCept, taking pregnancy tests within one week of use, and remaining on birth control until six weeks after discontinuing CellCept treatment. Finally, the FDA advised women planning to become pregnant to use CellCept only if no other immunosuppressant would be effective.
CellCept side effects also include neurological ones, namely Progressive Multifocal Leukoencephalopy (PMT). PMT is a rare virus that almost exclusively afflicts people on immunosuppressants. It attacks the white matter of the brain with symptoms including impaired speech, vision loss, impaired mobility, weakness and paralysis, and memory loss and cognitive deterioration. In June 2008, the FDA added this to CellCept’s Warning’s and Adverse Reaction section about postmarketing reports. Of the 17 people reported to have contracted PMT, 7 died.
Finally, in August 2009 the FDA alerted the public of a link between CellCept and a type of anemia called Pure Red Cell Aplasia (PRCA). Considered an autoimmune disease, PRCA causes people’s bone marrow to cease creating red blood cells. Symptoms include fatigue, lethargy, and paleness of skin. It is usually non-life-threatening. Hoffman-La Roche discovered that 41 CellCept users developed PRCA and that in 16 of those cases merely reducing the CellCept dose eliminated symptoms.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a CellCept lawsuit on your behalf if necessary.
If you have taken CellCept and believe it harmed you or your child, contact RLG today.