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FDA approves pill with sensor to digitally track medication ingestion

14 November 2017

Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.

USA regulators have approved the first pill that can be digitally tracked through the body.

USA regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

The Food and Drug Administration said that the ability to track ingested medicines for mental illness may be useful "for some patients", even if the capability of the digital pill to increase patient compliance has not yet been proven. "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers".

Once a patient swallows the pill a sensor sends a message to a wearable patch.

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The drug is approved for the treatment of bipolar I disorder characterized by the occurrence of at least one manic or mixed episode, schizophrenia, and add-on treatment for depression in adults. The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times.

Although now approved, Abilify MyCite will carry a warning in its labelling stating that the system has not been shown to improve patient compliance and that it "should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur".

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Prior to patient use, the FDA urges healthcare providers to ensure that the patient is able to use the system. "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".