What is CellCept/Myofortic?
CellCept, also known as Mycophenolate mofetil (MMF), is manufactured and sold by the Swedish pharmaceutical company Hoffman-La Roche. The drug was introduced to the market and approved by the FDA and May of 2005, and approved as a 250 mg oral capsule. The drug is supposed to counteract kidney, liver, and heart rejections in transplant patients. CellCept is the leading brand transplant medication for fighting transplant rejection in the United States, and it is estimated that close to 600,000 patients have taken the drug worldwide.
There have been many serious side effects linked to use of CellCept, and a major problem is the potential harmful effects it can have during pregnancy. It has been linked to a significant risk of pregnancy loss and congenital malformations, in particular, external ear or facial abnormalities such as cleft lip and palate. It also is said to cause an increase in anomalies of the distal limbs such as the heart, kidney, or esophagus.
Based on a study done by the United States National Transplantation Pregnancy Registry, 33 pregnancies that were exposed to MMF, and of these 33 there were 15 miscarriages and 4 birth defects. It was an alarmingly high rate which caused the FDA to up the pregnancy warning to patients who use CellCept and other similar products. CellCept now carries and Category D risk of pregnancy, this means there is positive evidence of fetal risk. The FDA also issued a “black box warning”, the highest warning given out by the FDA; this warning was added to the label of CellCept, and well as a similar drug, Myofortic.
Currently there are more ongoing tests in regard to use of CellCept and its potential negative impact on patients. The FDA is currently running a study that is seeking to determine if use of CellCept, or Myofortic, can lead to the development of a very serious disease called progressive multifocal leukoencephalopathy (PML). This disease is a very rare, life-threatening disorder that affects the central nervous system. This severe side effect is mostly associated with patients with suppressed immune systems. A good amount of patients who develop PML do not survive the disease. Those lucky enough to survive may be permanently disables as a result of irreversible nerve damage.
There are certain side effects you can look for if you are concerned you or a loved one may have developed PML while taking CeptCell or Myofortic:
- Vision Change
- Loss of Coordination
- Memory Loss
- Difficulty Speaking or Understanding What People Say
- Weakness in the Legs
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate personal injuries, life threatening disorders, failed pregnancies and wrongful deaths resulting from taking CellCept or Myofortic. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of using CellCept or Myofortic. If you or a loved one has been injured or killed as a result of CellCept or Myofortic use, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog