Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
HEALTH CANADA ADVISORY
November 2, 2015
Health Canada has issued new restrictions concerning the use of Abilify and Abilify Maintena (aripiprazole). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abnormal heart rhythms: This medication can cause an abnormal heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heart beat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.
Blood clots: Rarely, this medication increases the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.
Body temperature: Aripiprazole, like other antipsychotic medications, may interfere with your body's ability to regulate body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down.
Take care to avoid overheating during strenuous exercise or in hot temperatures, and avoid becoming dehydrated by drinking enough fluids.
Diabetes: Aripiprazole may increase blood sugar for people with diabetes or those who are at risk for diabetes. If you have diabetes, monitor your blood sugar frequently as recommended by your doctor. If you experience symptoms of high blood sugar (e.g., increased urination, increased thirst, increased eating, and weakness) while taking this medication, contact your doctor.
Drowsiness/reduced alertness: Aripiprazole may cause drowsiness or lightheadedness, which could interfere with your ability to do activities requiring alertness, such as driving a car. Avoid these activities if the medication affects you in this way. Avoid alcohol while taking aripiprazole as it may increase your drowsiness.
Infection: Rarely, this medication will reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor if you notice more frequent signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Lactose: This medication contains lactose and should not be taken by people with rare problems of galactose intolerance or problems absorbing glucose or galactose.
Low blood pressure: Some people taking aripiprazole may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor.
If you have or have had heart disease, stroke, "mini-stroke", or are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Neuroleptic malignant syndrome (NMS): This medication may cause a potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating, or irregular heartbeat, stop taking this medication and seek immediate medical attention.
Seizures: Seizures have occurred in people taking aripiprazole. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience a seizure while taking this medication, get immediate medical attention.
Swallowing problems: People taking aripiprazole may have difficulty swallowing. Seniors and people on other antipsychotic medications should be closely monitored by their doctor for swallowing problems while they are using this medication. If you experience difficulty swallowing while taking this medication, contact your doctor.
Tardive dyskinesia: People taking this medication may develop tardive dyskinesia, a syndrome of uncontrolled body movements. This syndrome may be irreversible. If you develop uncontrolled or unusual body movements, contact your doctor as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking aripiprazole, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication have not been established for children less than 13 years of age. Aripiprazole may be used by adolescents 15 years and older to treat schizophrenia. It may also be used by adolescents 13 years and older to treat bipolar disorder. The use of aripiprazole to aid in the treatment of depression has not been studied for this age group and is therefore, not recommended. Movement disorders such as tardive dyskinesia are more likely to occur in this age group. Report any unusual body movements to your doctor as soon as possible.
Seniors: Seniors taking this medication for dementia-related psychosis have a higher risk of strokes and death compared to seniors who are not taking the medication. Aripiprazole is not approved or recommended for seniors for this purpose.