FDA Approves Digital Pill

FDA approves the first pill that can alert your doctor when you swallow it

FDA approves the first pill that can alert your doctor when you swallow it

The treatment is called Abilify MyCite, which is meant to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use as an add-on treatment for depression in adults. Once ingested it's able to send a message from the sensor packed into the pill to a wearable smart patch that's worn on the rib cage.

The FDA's approval does come with some conditions, though.

The tracking system provides a way for doctors to objectively measure if patients are sticking to their medication schedules, opening doors for monitoring medicine intake methods in other areas of medicine and health care.

This allows patients can track their meds on their smartphone; it also enables caregivers and physicians to access adherence through a web-based portal, when given permission.

"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.

"H$3 aving fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients' experiences", the company said in its announcement. The drug contains a warning box for professional healthcare workers that elderly patients with dementia-related psychosis are treated with antipsychotic drugs.

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement.

The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. Quoted in the New York Times, Harvard Medical School instructor Ameet Sarpatwari, MD, said a digital pill "has the potential to improve public health", but added that, "if used improperly, it could foster more mistrust instead of trust".

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the US healthcare system an estimated $200 billion per year. The agency rejected the drug-device combo last April, and the two companies resubmitted their application in May.

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