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.
And psychiatrist Dr. Peter Kramer, who wrote "Listening to Prozac", said drugs like Abilify Mycite come with a built-in "tattletale". That information produced can also be accessed by caregivers and physicians through a web-based portal so they are able to keep track of the patients as well.
In a portion of the statement that appeared to address privacy concerns, the FDA said the wearable patch that comes with the medication "transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone".
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The drug-device combination is approved for several of the same indications as regular Abilify, including schizophrenia, add-on therapy for depression in adults, and. acute treatment of manic and mixed episodes associated with bipolar I disorder.
"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", he added.
Aripiprazole is approved with a Boxed Warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis.
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Abilify MyCite is not approved for treating patients with dementia-related psychosis. Other warnings include an increased risk of possible suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. While the rates at which patients deviate from their treatment regimens vary, estimates hold such actions cost the USA healthcare system hundreds of billions of dollars each year. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. Skin irritation at the site of the MyCite patch placement may also occur.
Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the USA each year in "caring for health conditions that are attributable to nonadherence".
The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times.
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The FDA has approved the first drug with a digital ingestion tracking system, according to a press release.