FDA Boxed Warning Updates
Updated boxed warnings for prandimet, avandamet, optiray, glumetza, sabril, and valcyte
Federal Practitioner. 2017 October;34(10):16-17
October 23, 2017|Federal Practitioner
VALCYTE (VALGANCICLOVIR HYDROCHLORIDE):
- Edited boxed warning April 7, 2017
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
- Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with Valcyte.
- Impairment of Fertility: Based on animal data, Valcyte may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
