FDA Issues MedWatch on Novartis' Myfortic
The labeling for Novartis’ kidney transplant drug Myfortic now carries a black box warning indicating use of the drug during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.
The FDA issued a MedWatch Alert for Myfortic (mycophenolic acid) Nov. 27 after issuing a similar one for Roche’s transplant drug CellCept (mycophenolate mofetil) last month. CellCept now carries a warning of pregnancy loss and congenital malformations.
The latest MedWatch stated that mycophenolate mofetil is converted into mycophenolic acid following oral or intravenous administration.
Based on postmarketing data collected from women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for both drugs has been changed to Category D, meaning there is positive evidence of fetal risk.
Patients planning to become pregnant should not use either drug unless they cannot be successfully treated with other immunosuppressant drugs, according to Novartis’ and Roche’s “dear doctor” letters.
Female patients of childbearing potential must use contraception while taking either drug, but they should be aware that the drugs reduce blood levels of the hormones in oral contraceptives and could reduce their effectiveness.