CellCept mycophenolate mofetil regulatory update

FDA approved an updated label for Roche's CellCept mycophenolate mofetil to include a black box warning on embryofetal toxicity, malignancies and serious infections. The agency also added a warning stating that the use of CellCept during pregnancy is associated with an increased risk of first trimester pregnancy loss and congenital malformations, and that female patients of childbearing potential must be made aware of increased risks and counseled on pregnancy prevention and planning. Additionally, FDA said CellCept should be used with caution when co-administered with proton pump inhibitors in transplant patients. Roche markets the reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH) to prevent organ rejection in patients receiving renal, cardiac or hepatic transplants, and to prevent organ rejection in pediatric patients receiving renal transplants. ...