FDA Approves Drug With Sensor That Digitally Tracks if Patients Have Ingested Their Medication

November 15, 2017

ROCKVILLE, Md -- November 14, 2017 -- The US Food and Drug Administration (FDA) has approved the first drug in the United States with a digital ingestion tracking system (Abilify MyCite).

The aripiprazole tablets have an ingestible sensor embedded in the pill that records that the medication was taken.

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

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, MD, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “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.”

It is important to note that it is not known if this product improves patient compliance.

The tablet with sensor should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.

The aripiprazole tablets with an ingestible sensor contain a Boxed Warning alerting healthcare professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The product is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behaviour in children, adolescents and young adults taking antidepressants. The safety and effectiveness of aripiprazole tablets with an ingestible sensor have not been established in paediatric patients.

Aripiprazole tablets with an ingestible 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 placement may occur in some patients.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

SOURCE: US Food and Drug Administration

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