The Food and Drug Administration announced its approval Monday for the first digital medicine—a melding of a long-standing drug for schizophrenia—Abilify (aripiprazole tablets)—with an edible sensor that reports when it’s ingested. Together, they make Abilify MyCite.

Though the approval is a long time coming, the choice of an antipsychotic medicine for this advance is raising the eyebrows of some experts.

The digital ingestion tracking system works by embedding each Abilify tablet with a sensor “the size of a grain of sand,” according to the company behind it, Proteus Digital Health. The ingestible sensor is activated by gastric juices and sends a unique, identifying signal to a wearable patch. That patch automatically logs the date and time of the signal (as well as other basic health information) and can transmit that information via Bluetooth to a paired mobile device. The patient can sign consent forms to allow their doctors and up to four other people to receive the data. But the app that works with the digital drug system allows patients to revoke access to data at any time.

Proteus, a Silicon Valley company, has been working on the system for years and received FDA approval to market it in 2012. For this digital pill combination, it partnered with Japanese drugmaker Otsuka Pharmaceutical, which makes Abilify. The widely used drug has recently gone off patent, with generic aripiprazole tablets now available. However, Abilify MyCite is the only version currently approved with the digital tracking system.

Drug tracking

Proteus isn’t the only firm working on such a digital drug system—they have a lot of company. Tech developers and some health experts say that the systems will improve patient outcomes by helping patients stick to their meds and take them properly. They may even help track participants of clinical trials who are testing experimental drugs. And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example.

But so far, there’s no evidence that Abilify MyCite improves drug adherence, the FDA emphasizes. Previous trials of the digital drug simply demonstrated usability.

And there are potential downsides, too. For instance, patients could feel pressured to use the brand-name digital tracking drugs by doctors or insurance companies.

Then there’s the question of which patients would benefit—and if any would be harmed.

Several experts were concerned and puzzled that a treatment for schizophrenia was chosen for the first digital drug system. 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 of those 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,” Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department told the New York Times. “A system that will monitor their behavior and send signals out of their body and notify their doctor?” You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”

Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and New York-Presbyterian Hospital, echoed the sentiment to the Times, saying, “There’s an irony in it being given to people with mental disorders than can include delusions. It’s like a biomedical Big Brother.”

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