Big Brother 2.0? FDA Approves World's First Electronic "Smart Pill"


Patients can allow caregivers and physicians to access the information through an online portal.

There are a couple of caveats, though.

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.

The FDA noted that Abilify MyCite has not demonstrated an ability to improve patient compliance; therefore it should not be used to track medication ingestion in real-time or during an emergency, as detection may be delayed or may not occur. The ingestible sensor is activated by gastric juices and sends a unique, identifying signal to a wearable patch.

Would you be happy taking a tablet that beams information to your smartphone? And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example.

It's a pill that contains a minuscule chip-made of magnesium, silicon, and copper-that can send information from inside the body to an adhesive patch that's placed on a patient's torso.

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Users of the app - including the patient, but also any authorised doctors or family members - can then check in on the patient's ingestion data, keeping direct tabs on the timely swallowing of oral medication in private like never before.

In Australia, Abilify is used to treat symptoms of schizophrenia and mania in bipolar disorder.

Beginning in 2018, the launch of Abilify MyCite "will be conducted in close collaboration with only a select number of health plans and providers", according to a joint press release from Proteus Health Systems, the makers of the pill's digital sensor, and Otsuka Pharmaceutical Co., the maker of Abilify.

Nevertheless, the regulatory approval is a big win for Proteus, which has been promoting its self-tracking pill technology as a way to help patients take their medicine as prescribed.

"This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies", Otsuka president and representative director Tatsuo Higuchi said.

Experts though, have expressed concerns over what the pill might mean for privacy. This is the first drug in the United States with a digital ingestion tracking system. "I see a difference in using this technology to help people comply, as many people want to, versus a way to have families or the courts scrutinize their behavior". But the pill hasn't been approved for use here.