The wearable patch was developed by California-based Proteus Digital Health. It automatically activates when it comes into contact with stomach fluid, though it can take anywhere from half an hour to two hours to detect ingestion.
The patch on the torso can also transmit the signal to a web service, where a doctor can examine the data.
Patients can track their dosage on their smartphone and allow their doctors, family or caregivers to access the information through a website.
The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill.
The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year. The widely-used drug has recently gone off patent, with generic aripiprazole tablets now available.
The Japanese drugmaker has not said how it will price the digital pill.
Proteus isn't the only firm working on such a digital drug system-they have a lot of company. "The fact that someone might use this computer readout to decide if you are compliant-and that could affect your degree of freedom in society-is an issue that needs to be discussed and debated", she says.
The single biggest boon is the ability to track drug use.
Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently.
While it's the first time the FDA has approved such a pill, various specialty pharmacies and hospitals in the U.S. have previously "packaged" various drugs and sensors. Previous trials of the digital drug simply demonstrated usability.
Then there's the question of which patients would benefit-and if any would be harmed. Patients who use the digital drug would sign a consent form, yet the technology still creates the impression that the patient is being watched by a third party. The chronic and severe mental disorder can cause hallucinations, disordered thinking, and delusions, such as hearing voices and believing that other people are reading their minds or spying on them.
"Many [schizophrenia] patients don't take meds because they don't like side effects, or don't think they have an illness, or because they become paranoid about the doctor or the doctor's intentions", psychiatrist Paul Appelbaum from Columbia University told The New York Times.