U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Yea... (al changes inbehavior. Families and care...)

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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

Date:2/29/2008

al changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression (See Boxed WARNING).

Contraindications: Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular adverse reactions (eg, stroke, transient ischemic

attack), including fatalities, have been reported at an increased

incidence in clinical trials of elderly patients with dementia-related

psychosis treated 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 hy
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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Yea...(al changes inbehavior. Families and care...),Health