Label Changes for:
Metopirone (metyrapone USP) 250 mg, Capsules
November 2010
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010
ADVERSE REACTIONS
- Cardiovascular system: Hypotension
PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility
- ...Metopirone was not mutagenic with or without metabolic activation in three strains of bacteria.
Pregnancy Category C
- ... Animal reproduction studies adequate to evaluate teratogenicity and postnatal development have not been conducted with Metopirone.
