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

d with ABILIFY

Neuroleptic malignant syndrome (NMS) -- As with all antipsychotic

medications, a rare and potentially fatal condition known as NMS has

been reported with ABILIFY. NMS can cause hyperpyrexia, muscle

rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure,

cardiac dysrhythmia, and altered mental status. If signs and symptoms

appear, immediate discontinuation is recommended

Tardive dyskinesia (TD) -- The risk of developing TD and the potential

for it to become irreversible may increase as the duration of treatment

and the total cumulative dose increase. Prescribing should be

consistent with the need to minimize TD. If signs and symptoms appear,

discontinuation should be considered since TD may remit, partially or

completely

Hyperglycemia and diabetes mellitus -- Hyperglycemia, in some cases

associated with ketoacidosis, coma, or death, has been reported in

patients treated with atypical antipsychotics including ABILIFY.

Patients with diabetes should be monitored for worsening of glucose

control; those with risk factors for diabetes should undergo baseline

and periodic fasting blood glucose testing. Patients who develop

symptoms of hyperglycemia should also undergo fasting blood glucose

testing. There have been few reports of hyperglycemia with ABILIFY

ABILIFY may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.

As with other antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, or motor skills. Patients should
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SOURCE Otsuka Pharmaceutical Co., Ltd.
Copyright©2007 PR Newswire.
All rights reserved

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