US FDA approves first drug with digital ingestion tracking system

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

The device works by transmitting a message from the pill to a wearable patch, which then sends the data to a smartphone app, so that patients can keep track of their medication intake personally.

Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health.

Caregivers and physicians can also be permitted by the patients to get the information via a web-based portal.

'Abilify MyCite should not be used to track drug ingestion in real-time or during an emergency, ' the statement said, 'because detection may be delayed or may not occur'.

The U.S. Food and Drug Administration (FDA) made the first approval of a drug imbued with a digital ingestion tracking system.

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Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Dr Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. The FDA advises that patients should be monitored for this condition.

In combination though, the Abilify MyCite system was rejected by the FDA in April a year ago due to concerns over the possible impact of "human factors" on safety.

The tracking system provides a way for doctors to objectively measure if patients are sticking to their medication schedules, opening doors for monitoring medicine intake methods in other areas of medicine and health care. "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".

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