The U.S. Food and Drug Administration (FDA) made the first approval of a drug imbued with a digital ingestion tracking system. This is picked up by a wearable patch-worn on the left rib cage and replaced after seven days-which then sends the information to a smartphone app that allows patients to track when they took their medication.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, M.D., the director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a statement.
Although the sensor can alert caregivers, the makers of Abilify, Japan-based Otsuka Pharmaceutical, said it is unclear whether the tracking device will actually help improve patients' ability to take their medication daily as prescribed.
Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years. Patients can also grant healthcare providers access to the information through an online portal.
"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur".
Elderly patients with dementia-related psychosis treated with antipsyhotic drugs, such as Abilify MyCite, are at an increased risk of death.
What are some potentially risky risks of Abilify MyCite?
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. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults. This sensor is obviously ingested when the patient takes their medication; it provides data to a related patch the patient wears while taking the meds.
Abilify was first approved by the FDA in 2002 to treat schizophrenia. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.