First drug that can track whether it’s been swallowed OK’d by FDA

WASHINGTON — In a first, the Food and Drug Administration has approved a so-called digital pill that contains a sensor that lets the doctor know when it’s been taken.

The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify — long used to treat schizophrenia and bipolar disorder — with a sensor tracking system first approved in 2012. 

The technology is intended to help prevent dangerous emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder. 

CBS News chief medical correspondent Dr. Jon LaPook explains how the digital pill, Abilify MyCite, works. It’s a tiny chiplet — about the size of a grain of sand — that is combined with the medication and swallowed. It hits the stomach and a signal is beamed to a patch on the person’s skin. The patch then sends a signal to your iPhone saying the medication has been taken. 

The sensor, embedded in the pill, sends information to the wearable patch that can be accessed on a phone or tablet.

Proteus Digital Health

“There’s a big problem, which is that about 50 percent of people don’t take medicine the way they are supposed to, so hopefully this could give the patient the ability to get a reminder,” LaPook said. “Also, send a signal, if they want, to the doctor, if the patient chooses.” 

A patient will have to agree to the digital pill, so it wouldn’t be forced on anyone, LaPook said. There’s “no doubt” it could have implications for other diseases, LaPook said.

But developers Otsuka Pharmaceutical Co. and Proteus Digital Health are likely to face hurdles. The pill has not yet been shown to actually improve patients’ medication compliance, a feature insurers are likely to insist on before paying for the pill. Additionally, patients must be willing to allow their doctors and caregivers to access the digital information. 

Although the digital pill has raised some privacy concerns, LaPook said there are the same issues as having electronic medical records in a big hospital. 

Experts say the technology could be a useful tool, but it will also change how doctors relate to their patients as they’re able to see whether they are following instructions. 

“It’s truth serum time,” said Arthur Caplan, a medical ethicist at NYU’s Langone Medical Center. “Is the doctor going to start yelling at me?…

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