FDA Approves Fist Pill that Digitally Tracks Patient Compliance

The United States Food and Drug Administration has just approved a digital pill; it is the first to be embedded with a sensor aimed at transmitting whether someone has taken it.

Now, this might seem like something that nobody needs but many health professionals share concern that it is not always easy to know whether a patient is taking their meds; and that can be dangerous. After all, this new pill is known as Abilify MyCite; Abilify, of course, is the brand-name version of the Japane-based Otsuka Pharmaceutical antipsychotic drug aripiprazole. This drug is intended to treat schizophrenia and bipolar disorder as well as a potential add-on treatment for patients who take depression medications.

Indeed, FDA Center for Drug Evaluation director of the Division of Psychiatry Products, Dr. Mitchell Mathis notes, “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients. 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.”

It is important to note that in the announcement of the new drug, the FDA notes the label information, which states that the product has not been shown to improve treatment regimen compliance. In addition, the FDA also makes sue to comment that “Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or may not occur.”

Of course, some health experts are also surprised that the first drug of this ilk—with digital tracking—has been approved by the FDA since patients who take antipsychotic drugs are often schizophrenics; and schizophrenics often experience paranoia and even delusions that they are being tracked or watched.

Dr. Paul Appelbaum is the director of law, ethics, and psychiatry in the Department of Psychiatry with Columbia University. He explains, “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.”

He adds, “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.”

 

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