Abilify Maintena Recall
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Questions & Answers
Side Effects & Adverse Reactions
ABILIFY MAINTENA may cause serious side effects, including:
- Uncontrolled body movements (tardive dyskinesia). ABILIFY MAINTENA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY MAINTENA. Tardive dyskinesia may also start after you stop receiving ABILIFY MAINTENA.
- Problems with your metabolism such as:
- High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY MAINTENA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start receiving ABILIFY MAINTENA and during your treatment.
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
- Increased fat levels (cholesterol and triglycerides) in your blood.
- Weight gain. You and your healthcare provider should check your weight regularly.
- Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
- Low white blood cell count
- Seizures (convulsions)
- Problems controlling your body temperature so that you feel too warm.
- Difficulty swallowing
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities)
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
- Tardive Dyskinesia: Discontinue if clinically appropriate
- Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain
- Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with and at risk for diabetes
- Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics
- Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended
- Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease
- Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts in patients with a history of a clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC). Consider discontinuation if clinically significant decline in WBC/ANC in the absence of other causative factors
- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
ABILIFY MAINTENA (aripiprazole) is indicated for the treatment of schizophrenia
There is currently no drug history available for this drug.
Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2•H2O and its molecular weight is 466.40. The chemical structure is: