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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia
Date:11/6/2007

not drive or operate hazardous machinery until they are certain ABILIFY does not affect them adversely.

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY; use caution in patients at risk for aspiration pneumonia.

The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder, and close supervision of high-risk patients should accompany drug therapy.

Physicians should advise patients to avoid alcohol while taking ABILIFY.

Strong CYP3A4 or CYP2D6 inhibitors increase ABILIFY drug concentrations when used concomitantly.

CYP3A4 inducers decrease ABILIFY drug concentrations when used concomitantly.

Commonly observed adverse events (greater than or equal to 5 percent incidence and at least twice the rate of placebo for ABILIFY vs placebo, respectively):

-- Adult patients with schizophrenia: akathisia (8 percent vs 4 percent)

-- Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal

disorder (17 percent vs 5 percent), somnolence (16 percent vs

6 percent), and tremor (7 percent vs 2 percent)

-- Adult patients with bipolar mania: constipation (13 percent vs

6 percent), akathisia (15 percent vs 3 percent), sedation (8 percent vs

3 percent), tremor (7 percent vs 3 percent), restlessness (6 percent vs

3 percent), and extrapyramidal disorder (5 percent vs 2 percent)

-- Adult patients with agitation associated with schizophrenia or bipolar

mania: nausea (9 percent vs 3 percent)

Please see FULL PRESCRIBING INFORMATION, including Boxed WARNING, for ABILIFY.

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SOURCE Otsuka Pharmaceutical Co., Ltd.
Copyright©2007 PR Newswire.
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