Pregnant women who take the immune-suppressing drugs CellCept or Myfortic can cause birth defects in their unborn babies, the FDA said. Manufactured by Roche and Novartis, the two drugs are approved for use by organ transplant patients to prevent organ transplant rejection.
It is common practise to use these drugs "off-label" to treat other immune system disorders, such as lupus, rheumatoid arthritis, and erythema multiforme, according to WebMD.
In October 2007, the FDA received reports of miscarriages and infants born with ear and mouth birth defects after their mothers took Roche's CellCept. It led the federal agency to add its most serious "black box" warning to CellCept and a similar Novartis AG drug, Myfortic.
Roche previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007. However, it has not received any new reports of miscarriages or birth defects since updating the drug's labeling.
The two drugs can lead not only to the risk of miscarriage during the first trimester but also to serious birth defects following exposure to MMF, the active ingredient in CellCept.
The FDA advised doctors to make sure that transplant patients are not pregnant and are using effective contraception before prescribing the drugs.
The FDA is also investigating 16 patients who developed a rare neurological disease, progressive multifocal leukoencephalopathy, while taking the drug. The disease attacks the brain and central nervous system and is usually fatal.
