A newly approved drug with an ingestible sensor lets caregivers know whether patients have taken their medication. Abilify MyCite is the first digital medicine to win U.S. Food and Drug Administration (FDA) approval. But it raises questions about patient privacy and renews attention on the antipsychotic drug Abilify’s serious side effects.

Abilify MyCite is approved to treat schizophrenia, acute treatment certain bipolar disorders and as an add-on treatment for depression in adults. It’s designed to prevent dangerous complications that can result from patients skipping their medications.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Dr. Mitchell Mathis of the FDA’s Center for Drug Evaluation and Research said. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA first approved Abilify in 2002 to treat schizophrenia. Since then, studies and lawsuits have blamed it for causing compulsive behavior and other side effects in people taking it. The FDA approved the tracking system in 2012, but Abilify MyCite is its first approved use with a drug.

The digital drug is a joint project between Abilify manufacturer Otsuka Pharmaceutical Co. and device maker Proteus Digital Health. Otsuka has not announced a price for Abilify MyCite yet, but plans to roll it out sometime in 2018.

How Does a Digital Drug Work?

The digital sensor in each pill is tiny — about the size of a grain of sand. It’s made from elements found in common foods — copper, magnesium and silicon. Contact between the elements and stomach fluids trigger an electrical signal.

A wearable patch on the patient’s body picks up the signal and relays the time and date via Bluetooth to a smartphone app. The patient can choose to automatically share this information with a doctor, family members or other caregivers.

Patients can add notes about their mood, how long they’ve rested and other activity information to the app. The information is stored in a database that caregivers can monitor.

Critics Warn of a ‘Big Brother’ Approach to Patient Care

Several other drug manufacturers are looking at similar digital drugs. They see people who are wary of missing doses as embracing the technology. Still others see it as a coercive or intrusive invasion of a patient’s privacy even with approval.

The technology could be embraced by people who fear missing a dose of medication for serious conditions HIV, heart attack and diabetes. Some medical experts also see it as a way to control and limit dosages for potentially addictive medications like opioids.

The monitoring could be highly beneficial in treating schizophrenia patients who can experience medical emergencies if they stop taking their medication. One study found nearly 3 in 4 schizophrenia patients stop taking their medication within 18 months.

But Dr. Peter Kramer, a psychiatrist who wrote the book Listening to Prozac, told the New York Times the concept was “packaging a medication with a tattletale.” Digital pills could monitor behavior in parolees or releasing patients from treatment programs.

And Abilify MyCite still faces other hurdles before it hits the market next year. The manufacturers have yet to prove it actually improves a patient’s compliance with taking drugs as scheduled. The whole concept also depends on a patient being willing to allow caregivers access to the pill’s digital information. These concerns could be critical in winning insurance coverage for Abilify MyCite.

Abilify Associated with Dangerous, Compulsive Behavior

Abilify has been associated with serious side effects. It even carries two black box warnings, the FDA’s most serious type. One warns that Abilify is not approved for elderly patients with dementia-related psychosis. The other warns of an increased risk of suicidal thinking or behavior in children, teens and young adults.

Studies have also found associations between Abilify and neuroleptic malignant syndrome, a life-threatening reaction to antipsychotic drugs, and tardive dyskinesia, which causes involuntary muscle movements of the lower face, and compulsive behaviors.

In addition, a federal panel combined more than 370 lawsuits over Abilify side effects into a multidistrict litigation in a Florida federal court in 2016. The people who filed the lawsuits claim the drug caused compulsive gambling, spending or eating along with hyper sexuality and stealing or shoplifting.