FDA approved Monday a drug with a digital ingestion tracking system. The product, aripiprazole tablets with sensor (Abilify MyCite—Otsuka Pharmaceutical, Proteus Digital Health), features an ingestible sensor embedded in the drug 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. "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," noted Mitchell Mathis, MD, director of the Division of Psychiatry Products in 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." FDA noted that the labeling information for Abilify MyCite points out that the ability of the product to increase patient compliance with their treatment regimen has not been shown. The product should not be used to monitor drug ingestion in "real-time" or during an emergency, as detection may be delayed or may not occur. The product includes a boxed warning noting that older adults with dementia-related psychosis treated with antipsychotic drugs are at a higher risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis. In addition, the boxed warning points to an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. The safety and effectiveness of the product have not been established in pediatric patients. FDA said Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.