U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Diso... (entially fatal condition known as NMS ha...)

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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)

Date:11/20/2007

entially 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 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 attribut
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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Diso...(entially fatal condition known as NMS ha...)