'Digital Pill' Tells Doctor When Patient Takes It

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

Abilify MyCite is the first pill of its kind to get FDA approval, though, paving the way for a new kind of drug that may aid in patient compliance. When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor.

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

Although the sensor can alert caregivers, the makers of Abilify, Japan-based Otsuka Pharmaceutical, said it is unclear whether the tracking device will actually help improve patients' ability to take their medication daily as prescribed. The pill is embedded with a tiny sensor about the size of a grain of sand that lets doctors know if and when a patient has taken their medication.

Using an app on their smartphone, patients can keep track of their dosage and allow their physicians to access information through a website.

Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed.




Aripiprazole is approved with a Boxed Warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis.

The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year.

In the case of Abilify, a patient who doesn't stick to the drug could end up in a psychiatric hospital, so Abilify MyCite may find its niche.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

What is the pill approved to treat? The sensor technology and patch are made by Proteus Digital Health.

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