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In clinical trials, Abilify was tested against placebo-controlled groups in acutely relapsed patients with schizophrenia. Three of the four short-term trials were able to distinguish Abilify from placebo. However, in the smallest study, the trials were unable to distinguish Abilify from placebo.

Before prescribing the new pill and tracking system, doctors should ensure that their patients are capable of and dedicated to using the system, says the FDA. The drug Abilify (with or without the digital sensor can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements. The MyCite stick-on patch may cause skin irritation in some people.

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism; Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic; and Antipsychotic Induced Structural and Functional Brain Changes.

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 include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain. Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes. Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics. Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight. Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation. Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls. Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including ABILIFY. Patients with a history of a clinically significant low white blood cell count (WBC or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC monitored frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Seizures/Convulsions: 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. Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients.

In its announcement, the FDA notes that Abilify MyCite’s labeling information states the product hasn’t been shown to improve patients compliance with their treatment regimen. It also says that Abilify MyCite should not be used to track drug ingestion in ‘real-time or during an emergency because detection may be delayed or may not occur.

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