The U.S. Food and Drug Administration said Tuesday it has approved Abilify MyCite (aripiprazole tablets) that has an ingestible sensor that records the medication was taken, the first drug in the U.S. with a digital ingestion tracking system.

The drug is approved for the treatment of bipolar I disorder characterized by the occurrence of at least one manic or mixed episode, schizophrenia, and add-on treatment for depression in adults.

Schizophrenia is a chronic, severe and disabling brain disorder, and its symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.

Abilify MyCite works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application, letting the patient track the ingestion. Patients can also allow their physicians and caregivers access to their data through the internet.

Abilify MyCite contains a Boxed Warning to alert healthcare professionals not to treat patients with dementia-related psychosis. 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. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

The most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body, anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may also occur.

Abilify was first approved by the FDA in 2002 to Otsuka Pharmaceuticals for the treatment of schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012 and was made by Proteus Digital Health.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”

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