Medication Guide App

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.
     

 

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