FDA Approves Smart Pills That Digitally Track When Patients Take Their Meds

FDA Approves Smart Pills That Digitally Track When Patients Take Their Meds

The first pill which can be digitally tracked as it makes its way through the body has been approved for use by the United States safety drugs watchdog, the Food and Drug Administration (FDA).

Abilify MyCite, a form of aripiprazole and a first-of-its-kind product, comes with an embedded ingestible sensor that records when the medication is taken.

While Abilify MyCite will not allow people to track in real-time, it can provide a delayed ability to chart treatment for serious mental disorders including schizophrenia, bipolar, and major depressive disorders.

The system works by sending a message from the pill's sensor to a wearable patch. Given permission, a patient's doctor can also view the information.

"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", said Mitchell Mathis of the FDA's Center for Drug Evaluation and Research.

The patch then transmits medication data to a smartphone app which the patient can voluntarily upload to a database for their doctor and other authorised persons to see.

"Once you have a tracking device in here and it's made available for this goal, my concern is that lawmakers and others will find reasons where they will create laws about requiring certain medications that have tracking devices to be used - and that the tracking devices will actually be used for access by the doctor", she pointed out. Its safety and effectiveness has not been established in paediatric patients.

The FDA notes that improving patient compliance with their treatment regime "has not been shown". The label also warns of increased risk of suicidal thinking and behavior among children, teens and young adults.

The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. Moreover, FDA commented that ABILIFY MYCITE should not be used in "real time" or during an emergency as the detection might take longer time or might not occur at all.

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