Experts raise eyebrows at digital pill to monitor patients with schizophrenia

Dora Pope
November 16, 2017

The tiny sensor used in the new pill was first approved by the FDA in 2012 and has since been available for pharmacies to place inside a capsule along with other medications.

Abilify MyCite is expected to hit the market next year, but the price has not yet been set.

Abilify MyCite is not approved for patients with dementia-related psychosis; it has a Boxed Warning that taking this medication puts patients with dementia-related psychosis at an increased risk of death.

The treatment is called Abilify MyCite, which is meant to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use as an add-on treatment for depression in adults.

The pill is a joint effort between Otsuka Pharmaceutical, maker of Abilify, and Redwood City, California-based Proteus Digital Health, which developed the sensor. Quoted in the New York Times, Harvard Medical School instructor Ameet Sarpatwari, MD, said a digital pill "has the potential to improve public health", but added that, "if used improperly, it could foster more mistrust instead of trust". 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.

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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.

The sensor itself is about the size of a grain of sand.

In a historic move by the US Food and Drug Administration (FDA), the first ever digital pill has been approved for use. Once ingested, the digital pill sends a wireless signal to the patch, which then transmits information to the app and to a companion web portal. But, the app that works with the digital drug system allows patients to revoke access to data at any time. "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients". It also should not be used to track drug ingestion in "real-time" or during an emergency. The drug Abilify (with or without the digital sensor) can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements. Abilify MyCite is also not approved to treat older patients with dementia-related psychosis. But the device may be particularly beneficial for certain patients with mental illness since taking medications as prescribed is particularly crucial for these people.

It's aimed at people who are being treated for schizophrenia and as an add-on treatment for adults suffering with depression.

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