7 things to know about the first FDA-approved ‘digital pill’ — How it works, side effects

The Food and Drug Administration on Monday approved the first pill that can be digitally tracked.

Here are seven things to know about the new digital pill, according to the FDA press release:

What exactly is it?

The FDA-approved pill, Abilify MyCite, consists of aripiprazole tablets, but with a sensor.

Aripiprazole is used to treat multiple mental mood disorders, including bipolar disorder and schizophrenia.

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How does it work?

The sensor in the pill digitally tracks whether or not patients have ingested their medication.

A message from the pill’s sensor is sent to a wearable patch, which transmits the information to a mobile app where patients can track the ingestion of medication on their smartphones.

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The information can also be accessed by caregivers and physicians through a web-based portal, but patients have to grant access.

What is the pill approved to treat?

Abilify MyCite is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder. The pill can also be administered as an add-on treatment for depression in adults, according to the FDA press release.

What are its side effects?

According to Abilify MyCite’s clinical trials, the most common side effects reported by adults taking the pill were:

  • nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • uncontrollable limb and body movements (akathisia)
  • anxiety
  • insomnia
  • restlessness
  • potential skin irritation at the site of the patch placement

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What are some potentially dangerous risks of Abilify MyCite? 

From Abilify MyCite’s boxed warnings:

  • Elderly patients with dementia-related psychosis treated with antipsyhotic drugs, such as Abilify MyCite, are at an increased risk of death.
  • Children, adolescents and young adults taking antidepressants are at an increased risk of suicidal thinking and behavior.

More about the pill’s boxed warnings.

Will the pill ensure patients take their medicine?

Not necessarily. Abilify MyCite notes under its label that the product’s ability to improve patient compliance with their treatment regimen has not been shown.

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But “being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said.

Who created the pill?

According to the news release, the FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The technology in the sensors and the patch are developed by Proteus Digital Health.

Read the full news release at FDA.gov.

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