FDA approves pill with sensor to digitally track medication ingestion

Self-tracking medicine will soon be available for Abilify oral tablets sometime next year

The pill then transmits this data to a wearable patch that subsequently transfers the information to an app on a paired smartphone.

The digital pill combines two existing products, former blockbuster psychiatric medication "Abilify" that is used to treat schizophrenia and bipolar disorder with a sensor tracking system first approved in 2012.

Smart pills are a thing and they've come one step closer to entering the mainstream after the FDA approved a pill packed with a digital sensor for the first time in the US.

In combination though, the Abilify MyCite system was rejected by the FDA in April past year due to concerns over the possible impact of "human factors" on safety. Proteus Digital Health, based in Redwood City California, makes the sensor. Also, a new drug has yielded to criticism. The sensor in the pill will then activate once its swallowed and reaches the patient's stomach fluid.

People who meet the criteria for Abilify MyCite can decide, along with their doctors and caregivers, whether this type of medication monitoring might help them manage their disease.

Abilify Mycite's prescribing information notes the ability of the product to improve patient compliance with their treatment regimen has not been shown. "Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur".

Proteus, along with Abilify creator Otsuka Pharmaceutical Co. Doctors having knowledge of the frequency and use of a patient's medication can help with understanding why a prescription is working or not and ensuring proper dosages are set. FDA said in the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia, and restlessness. Safety and effectiveness has not been established in children. The pill is not licensed for use by elderly patients with dementia-related psychosis. "And those things would not really be addressed by a pill with a sensor", she adds.

It's aimed at people who are being treated for schizophrenia and as an add-on treatment for adults suffering with depression. "This could be an unbelievable intervention for individuals and their families that would allow them to check in every day or two, without having to go to a higher level of care".

If so, we could soon be looking at a new level of data-driven surveillance in the healthcare sector, bringing up all kinds of questions and concerns about ethics, privacy, personal rights, and whether this kind of ingestion tracking can truly be safeguarded in the interests of the patient.

Let's say you're the patient.

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