FDA Approves First Digital Pill That Tracks Medicine Intake

FDA Approves First Digital Pill That Tracks Medicine Intake

The U.S. Food and Drug Administration has your back, approving the first digital tracking pill in the country. Approval of Abilify MyCite (aripiprazole tablets with sensor) comes as its manufacturer, Otsuka, is also marketing its once-a-month version of the therapy, which is approved for both schizophrenia and bipolar I disorder, 2 of the most debilitating mental health conditions.

The system works by sending messages from a pill sensor to a usable patch material, which then transmits the information to the mobile app so that patients can track drug consumption on their smart mobile phone. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too.

In combination though, the Abilify MyCite system was rejected by the FDA in April previous year due to concerns over the possible impact of "human factors" on safety.

The company notes that Abilify MyCite is meant to track drug ingestion, pointing out, "The ability of Abilify MyCite to improve patient compliance or modify aripiprazole dosage has not been established".


The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues.

Otsuka explains, "The system has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialogue with their healthcare team". The sensor, which has no battery or antenna, is activated when it gets wet from the fluids in the stomach, according to Reuters.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA. "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients". This patch in turn sends signals to the patients' smartphone, telling them whether or not they've taken the pill, along with the pertinent dates and times.

The pills are not licensed to be used in elderly patients with dementia-related psychosis. Typically, it can take anywhere between 30 minutes and two hours for pill ingestion to be detected. The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.

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