Health Care

FDA approves smart pill that lets doctors know when it's been swallowed

FDA approves smart pill that lets doctors know when it's been swallowed

The medicine is a version of Otsuka Pharmaceutical Co Ltd's established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health. 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.

"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER".

A digital pill embedded with a sensor that can tell doctors whether patients have taken their medicine has been approved in the US.

The FDA has approved the first drug with a digital ingestion tracking system, according to a press release.

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement.

Abilify MyCite contains a Boxed Warning to alert healthcare professionals not to treat patients with dementia-related psychosis.

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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.

Abilify MyCite is not approved for treating patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. While the rates at which patients deviate from their treatment regimens vary, estimates hold such actions cost the US healthcare system hundreds of billions of dollars each year.

Patients are given the option to sign a consent form allowing their doctor and up to four family members or care-givers to receive information about when the pills were taken.

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. Skin irritation at the site of the MyCite patch placement may occur in some patients.

The FDA granted the approval of the digital drug Abilify MyCite to Otsuka Pharmaceutical.


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