FDA approves new pill - tracks what medications you take

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The Food and Drug Administration (FDA) issued a first-of-its-kind approval on Monday, approving the first drug in the United States with a digital ingestion tracking system. The new pill, called Abilify MyCite, contains an ingestible sensor that can help patients (and their doctors and caregivers) keep track of whether they are taking their medication as directed.

Abilify MyCite is approved for the treatment of schizophrenia and bipolar I disorder, and as an add-on treatment for depression in adults.

The tiny sensor used in the new pill was first approved by the FDA in 2012 and has since been available for pharmacies to place inside a capsule along with other medications.

Now, however, the technology has been integrated directly into a pill and can be marketed—along with a wearable patch and a mobile application—for the treatment of specific health conditions. The drug Abilify is also available as a generic (aripiprazole), but only the brand-name product will be available with a sensor.

Abilify MyCite’s safety has not been established in children and adolescents. And because elderly people with dementia-related psychosis are at increased risk of death when taking antipsychotic drugs, the drug is not approved in this population, either.

Failing to stick to a regular medication regimen is a common problem, particularly for people with serious mental health issues, says Dr. Dolores Malaspina, director of the psychosis program at the Ichan School of Medicine at Mount Sinai. “Many of these people do not recognize that they have a disorder, or they don’t like the side effects of medication, or they stop taking it once they feel better,” she says. “And those things would not really be addressed by a pill with a sensor,” she adds.

But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take—or forget if they’ve taken—their medication for the day. “For those reasons, a device like this could indeed be very helpful, and I think it should be applauded,” Malaspina says.

he advent of digital drugs also raises concerns about patient privacy and coercion. “Many people with schizophrenia or bipolar disease are ordered by the courts to take their medication,” says Malaspina. “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. “I see a difference in using this technology to help people comply, as many people want to, versus a way to have families or the courts scrutinize their behavior.”