FDA approves first digital pill

Abilify MyCite is used for the treatment of schizophrenia, manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults.

A patient ingests the pill, and a sensor inside the pill activates when it reaches the stomach fluids, sending a message to a wearable patch. Patients must give their consent for others to know they've taken their pills, but this could be open to abuse - even from doctors or family members acting with the best intentions. The patch connects to a smartphone app via Bluetooth where people with access can read the information gathered by the sensor.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, in a statement Monday afternoon.

Abilify MyCite's labeling information also notes the product's ability to improve treatment compliance in patients has not been proven.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur". Abilify MyCite is not approved to treat patients with dementia-related psychosis.

Children, adolescents and young adults taking antidepressants are at an increased risk of suicidal thinking and behavior.

Abilify MyCite's future isn't certain, however.

The idea of tracking whether patients are taking anti-psychotic medication might seem appealing to medical professionals and other caregivers, it's worth a pause for thought.

Abilify MyCite comes in the form of a pill, outfitted with what's called an Ingestible Event Maker (IEM). After all, while doctors prescribe us pills and recommend treatment, unless we are sectioned our health and the care of it is still our private business.

Abilify was first approved by the FDA in 2002 to treat schizophrenia.

But until now, the FDA had not approved a sensor-pill combination.

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year.

Vanessa Coleman

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