November 16, 2017 – The American Food & Drug Administration (FDA) just approved Ability MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication. This is a very first in its class at the new age of digital health.
Originally Aripiprazole (Abilify) was approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. The all new Aripiprazole (Abilify MyCite) (i.e., aripiprazole tablets with an sensor) is approved for the same indictions. It comes, however, with an ingestible sensor embedded in the pill that records that the medication was taken. Thus, the Abilify MyCite features a sensor the size of a grain of sand made of silicone, copper, and magnesium. An electrical signal is activated when the sensor comes into contact with stomach acid. A patch the patient wears on their left rib cage receives the signal several minutes after the pill is ingested. The patch then sends data like the time the pill was taken and the dosage to a smartphone app over Bluetooth. The patch also records activity levels, sleeping patterns, steps taken, activity, and heart rate, and must be replaced every seven days. The patient’s doctor and up to four other people chosen by the patient, including family members, can access the information. The patient can revoke access at any time. It is assumed that the sensor as such passes through the body naturally.
Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their
thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.
The drug label of Aripiprazole (Abilify MyCite), as does the drug label of the regular Aripiprazole (Abilify) which is approved since 2002, contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole (Abilify MyCite) is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Aripiprazole (Abilify MyCite) have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Aripiprazole (Abilify MyCite) must be dispensed with a Patient Medication Guide that describes important information about the drug’s uses and risks. Other common adverse drug effects reported by patients taking Aripiprazole (Abilify) were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. With Aripiprazole (Abilify MyCite, skin irritation at the site of the MyCite patch placement may occur in some patients.
Patients should be well aware of the fact that new technology per se does not alleviate the serious health problems that come along for some patients who take Aripiprazole (Abilify) or antidepressant drugs in general, or their compliance with treatment. However, according to FDA, being able to track ingestion of medications prescribed for mental illness may be useful for some patients, and 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. Thus, Aripiprazole (Abilify MyCite) comes after years of venture research between Japanese pharmaceutical company Otsuka and digital medicine service Proteus Digital Health, which makes the sensor. Aripiprazole (Abilify MyCite) is one way to address the prevalent problem of patients not taking their medication correctly, with the IMS Institute estimating that the improper and unnecessary use of medicine cost the US healthcare sector over $200 billion in 2012.
Some serious questions might arise around digital pills, however. One question would be on what a digital pill might mean for patient privacy. Some are worried that tracking such pills will be a step towards punishing patients who don’t comply for whatever reason with treatment. This could mean that digital pills have the potential to improve public health but also to foster more mistrust instead of trust between caregivers and patients. Not to forget the role of insurers who potentially will have access to all these patient data as well. A second question could be as to the health effects on patients who are continouly exposed to silicon and all the other materials who make up the sensor. Where does all that silicone go? And last but not least, how to prevent patients from simply deceiving the system by exposing the sensor to 1 N HCl outside of the body in order to trigger the communication?
Ph.D.; Professor in Pharmacology and Toxicology.
Senior expert in theragenomic and personalized medicine and individualized drug safety.
Senior expert in pharmaco- and toxicogenetics.
Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
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