Precautions and Warnings With Aripiprazole (Cont.)

• The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of aripiprazole in elderly people with dementia (a condition involving confusion; disorientation; and a loss of memory, intellect, and judgment) or psychosis.

Elderly people with dementia (Alzheimer's disease is the most common form of dementia) who are treated with atypical antipsychotics -- including aripiprazole -- are more likely to die (of various causes) than those who are not treated with those medications. Aripiprazole is not approved to treat dementia in the elderly, and caution should be used before using aripiprazole in elderly people with dementia.

• Aripiprazole can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:

• A high fever
• Stiff muscles
• Confusion
• Irregular pulse or blood pressure
• A fast heart rate (tachycardia)
• Sweating
• Irregular heart rhythms (arrhythmias).

Tell your healthcare provider right away if think you might have NMS.

• Aripiprazole can cause tardive dyskinesia, a condition involving unusual, uncontrollable body or face movements. The condition can become permanent (even if aripiprazole is stopped). The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking aripiprazole.
   
• There is an increased risk of stroke in elderly people who take aripiprazole for dementia. Aripiprazole is not approved for the treatment of dementia in the elderly -- though it may sometimes be prescribed "off-label" for the treatment of behavior problems in elderly people with dementia.
   
• Aripiprazole can cause an increase in blood sugar levels and may increase the risk of developing diabetes. Tell your healthcare provider if you develop signs of diabetes while taking aripiprazole. Signs of diabetes can include increased thirst, increased urination, or hunger. If you have diabetes, your blood sugar should be monitored carefully and regularly during treatment with aripiprazole to make sure your diabetes is not becoming more severe (see Abilify and Diabetes).
   
• Aripiprazole can cause a drop in blood pressure when going from a sitting or lying position to standing (known medically as orthostatic hypotension). This can cause a person to have lightheadedness or dizziness, or to faint. Tell your healthcare provider if you have any of these symptoms when standing. Orthostatic hypotension can be especially dangerous in people with heart disease or congestive heart failure (CHF).
   
• Aripiprazole may increase the risk of seizures. Before starting aripiprazole, tell your healthcare provider if you have epilepsy or a history of seizures.
   
• Aripiprazole can cause difficultly swallowing, which can lead to inhalation of food (causing pneumonia). Tell your healthcare provider if you notice any problems swallowing.

• All antidepressants must carry a warning stating that antidepressants may increase the risk of suicidal thinking or behavior. Although aripiprazole is not technically an antidepressant, it must carry this warning because it can be used to treat depression.

• Aripiprazole is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Be sure to talk with your healthcare provider about the risks and benefits of using aripiprazole during pregnancy (see Abilify and Pregnancy).
   
• If is not known if aripiprazole passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about using aripiprazole (see Abilify and Breastfeeding for more information).
   
• You should generally avoid alcohol while taking aripiprazole (see Alcohol and Abilify).
   
• People with phenylketonuria (a certain genetic disorder) should be aware that Abilify Discmelt^® tablets contain phenylalanine. Regular aripiprazole tablets do not contain phenylalanine.
   
• Aripiprazole can interact with certain other medications (see Drug Interactions With Aripiprazole).