Safety

Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

December 2014

Summary View

WARNINGS AND PRECAUTIONS

  • Substantial Edits to Section 5.6 Metabolic Changes based upon two adequate and well-controlled trials that demonstrate the efficacy for the new indication in pediatric patients with Tourette’s Disorder.
     

 

July 2013

Summary View

USE IN SPECIFIC POPULATIONS

Nursing Mothers
  • Aripiprazole is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

February 2012

Summary View

WARNINGS AND PRECAUTIONS

Metabolic Changes
  • Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain. While all drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile…
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. There were no significant differences between aripiprazole- and placebo-treated patients in the proportion with changes from normal to clinically significant levels for fasting/nonfasting total cholesterol, fasting triglycerides, fasting LDLs, and fasting/nonfasting HDLs. Analyses of patients with at least 12 or 24 weeks of exposure were limited by small numbers of patients…
  • Weight Gain:Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended…

 

Page Last Updated: 01/15/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.