FDA Safety Labeling Changes: April-June 2017

Safety Labeling Changes and Boxed Warning Highlights Approved by FDA

Teresa Rubio, PharmD

Disclosures

August 31, 2017

Editorial Collaboration

Medscape &

Valganciclovir hydrochloride (Valcyte®)

For more on this Drug Safety Labeling Change, click here and here.

For full prescribing information for Valcyte®, click here.

Updated Boxed Warning

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.

Comments

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