The US Food and Drug Administration (FDA) today issued an alert to healthcare professionals about the dangers associated with Roche’s CellCept (Mycophenolate Mofetil) including “increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.”
The findings come from post marketing data minded from the US National Transplantation Pregnancy Registry, as well as information collected in women exposed to systemic mycophenolate mofetil during pregnancy.
The FDA has deemed that CellCept’s risk category be upgraded from C (risk is possible) to D (positive evidence of fetal risk).
At this point it does not look like CellCept is being recalled (the drug is important to a lot of people, and has a very limited use), but all drugs containing mycophenolate mofetil are to have a warning on the box that includes wording related to the increased risk of birth defects and loss of pregnancy.
The FDA approved mycophenolate mofetil in 1995 to prevent organ rejection in patients who have had kidney, heart or liver transplants. It is estimated that 459,000 people have taken this drug, which is marketed as CellCept by the pharmaceutical company Roche.