Evidence-Based. Clearly Delivered.
Evidence-Based. Clearly Delivered.
On November 14, 2017, the FDA announced its approval of the first drug in the U.S. with a digital ingestion tracking system. Aripiprazole tablets can now be prescribed that contain an ingestible sensor, embedded in the pill, that records that the medication was taken. Aripiprazole is used to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and depression in adults. The pill’s sensor sends a message to a wearable patch. The patch then sends the information to a mobile application that allows patients to track the ingestion of the medication on their smart phone. Caregivers and physicians will be able to access the information through a web-based portal with patient consent. It has not yet been demonstrated that patient compliance will improve with this product.
The tracking system comes with a black box warning due to concerns related to increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis. • Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors. • The safety and effectiveness of ABILIFY MYCITE have not been established in pediatric patients.
In addition, clinical trials for aripiprazole identified common side effects such as nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. The patch associated with the sensor mechanism may result in skin irritation.
This tracking technology raises concerns about privacy and data security in this era of almost daily security breaches. Sensitive medical information could be accessed by unauthorized persons. Forced medication compliance as a condition for release from inpatient psychiatric treatment is also a potential threat to personal autonomy. There are limited circumstances under which an adult can be forced to take psychiatric medication. Is an adult who “consents” to medication monitoring by a digital tracking pill as a condition of release from inpatient psychiatric treatment really giving voluntary consent to treatment?
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
FDA Abilify Mycite: Highlights of Prescribing Information
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