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Otsuka America Pharmaceutical, Inc. Announces the Appointment of Mark Altmeyer as President and Chief Executive Officer
Date:2/12/2009

s not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).

Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).

Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

  • An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis
  • Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
  • Abnormal or uncontrollable movements of face, tongue, or other parts of body. These may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent
  • If you have diabetes, or risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected incr
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SOURCE Otsuka America Pharmaceutical, Inc.
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