FDA Approves First Pill That Tracks If You've Swallowed It

Alicia Farmer
November 14, 2017

But some doctors worry that digital medications could present their own problems, as patients feel "tracked" by medical professionals and others.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

USA regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology. It is approved for use in treating schizophrenia and bipolar disorder and as an add-on therapy for adult depression.

The smart pill works by transmitting a message from the pill's sensor to a patch, which then sends the information to a smartphone application, according to the FDA. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency", the statement said, "because detection may be delayed or may not occur".

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The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them.

Aripiprazole tablets with sensor includes a Boxed Warning that elderly patients with dementia-related psychosis receiving antipsychotic drugs have an increased risk of death. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

"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", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

"The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness", said Proteus CEO Andrew Thompson. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out.

Prior to patient use, the FDA urges healthcare providers to ensure that the patient is able to use the system.

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