FDA approves first 'digital pill' to track patients


U.S. regulators have approved the first pill that contains a digital tracking sensor to alert doctors and caregivers as to whether a patient is taking a medication as scheduled.

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

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.

Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed.

"Being able to track ingestion of medications prescribed for 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.

Once a patient swallows the pill a sensor sends a message to a wearable patch. The sensor activates when it reaches stomach fluids. Thatt completes a circuit between coatings of copper and magnesium on either side producing a tiny electric charge.

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In the long run, such digital pills can also be used to manage patients with other complicated treatment routines, such as diabetes or heart conditions.

The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012.

The unlisted Californian company has attracted investments from several large healthcare companies, including Novartis AG, Medtronic Inc and St. Jude Medical Inc, as well as Otsuka.

Should prescribes take to Abilify MyCite, the new formulation could help Abilify's maker Otsuka Pharmaceutical Co. Ltd.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence".

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. It comes as well with a Boxed Warning to alert healthcare professionals to the effects of antipsychotic drugs on elderly patients diagnosed with psychosis related to dementia, citing higher death risk.