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FDA Approves Sensor-Equipped Schizophrenia Pill


The Food and Drug Administration has approved the first pill to contain a digital ingestion tracking system. Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.

The decision approves the Ability MyCite system as a whole - both Abilify and Proteus Health's sensor and patch had previously been cleared individually in the US.

The sensor is able to track when the pill was taken, the dosage, and a plethora of other metrics similar to the information a fitness tracker might gather, such as activity levels, sleep patterns, and heart rate. A spokesperson told the publication the FDA is planning to hire more staff with "deep understanding" of software development in relation to medical devices, and engage with entrepreneurs on new guidelines.

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 pill has not yet been shown to actually improve patients' medication compliance, a feature insurers are likely to insist on before paying for the pill.

"It's truth serum time", Arthur Caplan, a medical ethicist at NYU's Langone Medical Centre said. Am I going to get a big accusatory speech?

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.

"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.




"Could this type of device be used for real-time surveillance?"

The drug - Abilify MyCite, developed by Otsuka Pharmaceutical will help to keep a track of patients, and whether they are taking the prescribed medicines in time or not. "The answer is of course it could", said Giordano.

Otsuka hasn't indicated how much the digitized Abilify pills will cost yet.

Each pill is embedded with a sensor that sends a message to a patch that you will wear on your arm.

The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%.

In the same article, Eric Topol, MD, director of Scripps Translational Science Institute, predicted that payers might eventually offer financial incentives to use digital bills, but anxious about the ethical issues that could present themselves if the if the technology was "so much incentivized that it's nearly is like coercion".

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