United States regulators approve first digital pill to track patients

Kelley Robertson
November 16, 2017

Schizophrenia drug Abilify MyCite becomes the first drug approved in the US with a sensor that digitally tracks if patients have ingested their medication.

This is particularly concerning because Abilify is typically used to treat mental illnesses like schizophrenia, bipolar disorder, and depression. The sensor works by sending a message from the pill to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. At first techno-blush, concerns about Big Brother tapping one's body fall to the wayside; patients can voluntarily give access to the information gathered by the sensor to their doctor and designated family members or caretakers.

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.

Abilify MyCite should not be used to track "real-time" medication ingestion because detection may be delayed or may not occur, the company warns.

FDA approval of Abilify MyCite was granted to Otsuka Pharmaceutical Co., Ltd.

The information that the sensors can send out can include the dosage, the exact time when the pill was taken, and even what the patient was doing at the time. The patch runs on a tiny battery, while the sensor itself-about the size of a grain of sand and made of ingredients found in food-is powered by fluids in the stomach.

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.


"This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies", Otsuka president and representative director Tatsuo Higuchi said.

Studies have not yet shown whether the addition of a digital tracking system will improve how well people comply with their medication regimen.

Doctors now have an easier - but controversial - way to know if their patients have taken their medication.

In Australia, Abilify is used to treat symptoms of schizophrenia and mania in bipolar disorder. However, Abilify MyCite is the only version now approved with the digital tracking system.

While patients could choose not to take the pill, its approval could raise questions about privacy and whether some patients might feel pushed into taking the digital pill.

"This technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way".

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