The U.S. Food and Drug Administration (FDA) has issued another warning on the organ transplant drugs CellCept and Myfortic. The drugs have been linked to birth defects and miscarriages and the FDA is currently investigating possible links to rare neurological diseases.

FDA warns of miscarriages and birth defects

The FDA has issued another warning about the possible links to miscarriages and birth defects from organ transplant drugs CellCept, manufactured by Roche Holding AG and Myfortic, manufactured by Novartis AG. The FDA had issued an initial warning on the drugs in October of 2007 and added a warning on the drugs’ labels, but felt that doctors did not fully understand the dangers. This second warning seeks to clarify those dangers.

Patients who experienced miscarriages or those whose children were born with birth defects generally took the drugs before they knew about their pregnancy. Birth defects included external ear and facial abnormalities including cleft lip and palate and anomalies of the distal limbs, heart, esophagus and kidneys. The FDA is warning doctors to test women for pregnancy before prescribing either drug and has reported that some patients were taking the drugs for off-label purposes such as arthritis or lupus.

FDA investigating links to neurological disease

In April 2008, the FDA reported that it was investigating 16 cases of patients who developed a rare neurological disease, or brain disorder, known as progressive multifocal leukoencephalopathy while taking CellCept or Myfortic. That investigation is ongoing.

,b>Information on CellCept

According to Roche Holding AG’s website on Cellcept, www.rocheusa.com/products/cellcept/, the drug (mycophenolate mofetil) is a medication given to people who have received kidney, heart or liver transplants to help keep their new organ(s) healthy. It does this by helping prevent the body’s defense system (the immune system) from perceiving the new organ as a “foreign” threat and attacking it (a process called “rejection”).

Information on Myfortic

According to Novartis AG’s website on Myfortic, www.myfortic.com/info/home/index.jsp/, the drug is specially designed for people who have had a kidney transplant. … [Myfortic acts] to slow down or suppress your immune system, preventing it from reacting to your kidney and allowing your kidney to be accepted as a healthy part of your body.

If you or your child has been injured due to CellCept or Myfortic, contact an attorney whose practice focuses in this area of law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To contact a qualified attorney, please click here. We may be able to help.