New pill technology allows digital tracking of ingestion

The US Food and Drug Administration (FDA) recently approved the first drug in the United States with the capability to track ingestion. Abilify MyCite (aripiprazole tablets with sensor) contains an ingestible sensor that records that the medication was taken.

The pill’s sensor sends a message to a wearable patch, which transmits the information to a mobile application. Patients can track the ingestion of the medication on their smart phone and can permit their caregivers and physician to access the information through a web-based portal.

Aripiprazole is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes of bipolar I disorder, and as an add-on treatment for depression in adults.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, MD, 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.”

The new drug’s prescribing information states that the product has not been shown to improve patient compliance with their treatment regimen. Aripiprazole tablets with sensor should not be used to track drug ingestion in “real-time” or during an emergency, as the detection may be delayed or may not occur.

The prescribing information also contains a Boxed Warning alerting health-care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The drug is not approved for treating patients with dementia-related psychosis. The Boxed Warning specifies that children, adolescents, and young adults taking antidepressants are at an increased risk of suicidal thinking and behavior, and that the safety and effectiveness of this system has not been established in pediatric patients.

Patients should be monitored for the worsening and emergence of suicidal thoughts and behaviors. Aripiprazole tablets with sensor must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

Skin irritation at the site of the patch may occur in some patients. Before initial use of this new system, the patient’s health-care professional should facilitate use of the drug, patch, and app to ensure the patient is able and willing to use the system.