FDA approves digital pill that alerts doctors when you take your medicine

FDA approves the first pill that can alert your doctor when you swallow it

FDA approves the first pill that can alert your doctor when you swallow it

The medication is indicated for the treatment of adults with schizophrenia, acute treatment of adults with manic and mixed episodes in bipolar I disorder, and as an add-on treatment for adults with depression. From that point, with a patient's consent, the data can be accessed by the patient's doctors or caregivers via a web portal.

Mitchell Mathis, director of the Division of Psychiatry Products in the FDA'sCenter for Drug Evaluation and Research, said, "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients".

The FDA is careful to note that there hasn't been an established association between using the digital pill platform and increased patient adherence to their drug regimens.

It's called Abilify MyCite and will be used to treat schizophrenia and a specific type of bipolar disorder. "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".

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.

The developers behind the tech, created by Proteus Digital Health, hope to inspire patients to take their medications more consistently. The agency said it the first drug in the United States with a digital ingestion tracking system.

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

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The sensor, which is about the size of a grain of salt, gets activated when it gets wet from stomach juices.

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.

Proteus was working on the pill for many years.

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".

While patients could choose not to take the pill, its approval could raise questions about privacy and whether some patients might feel pushed into taking the digital pill.

The landmark approval is the latest in an expansive rethinking of what constitutes a treatment.

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