FDA Approves First Pill With Ingestion Tracking System

The US Food and Drug Administration (FDA) recently approved the first drug with a digital ingestion tracking system—Abilify MyCite (aripiprazole tablets with sensor).

Abilify MyCite is indicated for adult patients with schizophrenia and manic and mixed episodes associated with bipolar disorder, as well as an add-on treatment for depression. The ingestible sensor embedded in the pill allows patients to track the ingestion of their medication on their smart phone by sending a message to a wearable patch that transmits the information to a mobile application. Patients can permit access to this information to caregivers and physicians.
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However, the ability of Abilify MyCite to improve patient adherence has not been established. The tracking system should not be used to track drug ingestion in “real-time” or during an emergency as detection might be delayed or might not occur.

Common adverse effects associated with Abilify included nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. Some patients also reported skin irritation at the MyCite patch site.

Additionally, Abilify MyCite contains a boxed warning of the increased risk of death among elderly patients with dementia-related psychosis and increased risk of suicidal ideation in children, adolescents, and young adults taking antidepressants. The drug is not approved to treated dementia-related psychosis and its safety and efficacy in pediatric patients has not been established. Patients receiving Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors and should be given a Medication Guide that describes important information on the drug’s uses and risks.  

—Melissa Weiss

Reference:

FDA approves pill with sensor that digitally tracks if patients have ingested their medication [press release]. FDA; November 13, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm?utm_campaign=11132017_PR_FDA%20approves%20sensor%20pill%20for%20Abilify&utm_medium=email&utm_source=Eloqua. Accessed November 14, 2017.