Label Changes for:
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets
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. |
| Sections Modified | Summary of Changes to Contraindications and Warnings |
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WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS
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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... |
