NEW WARNING
Novartis has issued a “Dear Healthcare Professional” letter to announce new warnings associated with mycophenolate (Myfortic), an immune suppressant used to prevent transplant rejection. Reports of serious congenital malformations and miscarriages that have occurred when the drug has been used during pregnancy have resulted in a change from Pregnancy Category C to Pregnancy Category D. Providers are required to counsel female patients of childbearing age to use effective contraceptives while on this drug and to advise the switch to another immune suppressant if a pregnancy is planned. The prescribing information now has a boxed warning about the risk of use during pregnancy and increased information about the related findings in the Precautions section.
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mycophenolate