US FDA approves first drug with digital ingestion tracking system

The sensor in Abilify MyCite is ingestible and can also record when the patients had taken the pill.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, and was subsequently rejected, with a request from the FDA for more information on the digital drug. "Patients can also permit their caregivers and physician to access the information through a web-based portal". The FDA said in a statement Monday that the digitally-enhanced medication "works by sending a message from the pill's sensor to a wearable patch".

Abilify MyCite has been approved for treating schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and also an add-on treatment for depression in adults.

The FDA warns that label claims suggesting aripiprazole tablets with sensor may improve medication adherence have not been proven. "Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or not occur", a statement from the FDA said.

Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

"Being able to track ingestion of medications prescribed for illness may be useful for some patients", said Dr. Mitchell Mathis, director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. The drug is now not approved to treat these patients, according to the FDA. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

The most common side effects of aripiprazole include nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

The system could be used to manage patients who have long, complex medical routines in the future. FDA said Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence". "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".

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