Monday, 23 September, 2019


FDA approves pill with sensor to digitally track medication ingestion

Patty Aguilar | 14 November, 2017, 18:33

The monitoring system, developed by Proteus Digital Health, works by sending a message from the pill's sensor to a wearable patch. "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".

FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge. Patients can also allow their physicians and caregivers access to their data through the internet.

Experts hope it could improve medication compliance, although the company that makes the tablets says this has not been proved for their product.

The pill should not be used to track digestion in "real time" or during an emergency, as detection could be delayed or faulty, the FDA warned.

The FDA advised that healthcare professionals should show patients how to use the drug, patch, and app before prescribing the medication.

Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently.

Aripiprazole tablets with sensor includes a Boxed Warning that elderly patients with dementia-related psychosis receiving antipsychotic drugs have an increased risk of death.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation may also occur due to the MyCite patch, according to the release. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

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

Patients are given the option to sign a consent form allowing their doctor and up to four family members or care-givers to receive information about when the pills were taken.

Abilify MyCite could be particularly useful for older patients who may welcome the ability to share their medication information with others, but has also raised concerns about the ability to effectively track patients. "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".

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