Label Changes for:

Abilify (aripiprazole) Tablets and Oral Solution

February 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Orthostatic Hypotension
  • Seizures/Convulsions
  • Potential for Cognitive and Motor Impairment

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Pediatric Patients (10 to 17 years) with Bipolar Mania
    • Commonly Observed Adverse Reactions
    • Table 7
  • Somnolence
  • Extrapyramidal Disorder
  • Fatigue
  • Nausea
  • Akathisia
  • Blurred Vision
  • Salivary Hypersecretion
  • Dizziness

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

WARNINGS AND PRECAUTIONS

Orthostatic Hypotension

Aripiprazole may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. The incidence of orthostatic hypotension-associated events from short-term, placebo-controlled trials...of pediatric patients 10 to 17 years of age (n=399) on oral Abilify included orthostatic hypotension (1.0%, 0%)...

The incidence of a significant orthostatic change in blood pressure...In pediatric oral aripiprazole-treated patients aged 10 to 17 years (0%, 0.5%), or in aripiprazole injection-treated patients (3%, 2%).

Seizures/Convulsions

In short-term, placebo-controlled trials, seizures/convulsions occurred in 0.2% (3/1894) of adult patients treated with oral aripiprazole, in 0.3% (1/399) of pediatric patients (10 to 17 years), and in 0.2% (1/501) of adult aripiprazole injection-treated patients...

Potential for Cognitive and Motor Impairment

Abilify, like other antipsychotics, may have the potential to impair judgment, thinking, or motor skills...

Hide
(web1)