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U.S. Department of Health and Human Services

Safety

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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) – 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…

 

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