(CNN)A psychiatric medication system in the form of a pill with a built-in digital tracking device gained approval from the US Food and Drug Administration on Monday.
Abilify MyCite, a form of aripiprazole and a first-of-its-kind product, has an embedded ingestible sensor that records when the medication is taken. Made by Japan-based Otsuka Pharmaceutical Co., the medication system is intended to treat schizophrenia, bipolar I disorder and depression in adults. Abilify without sensor technology was first approved to treat schizophrenia in 2002.
Schizophrenia, a psychotic disorder, includes symptoms of delusions and hallucinations. Bipolar patients may experience alternating episodes of mania and depression, a persistent sadness.
Though the idea behind Abilify MyCite is to improve a patient’s compliance with their medication regimen, the FDA noted that this has not been proved.
Teens and young adults who are taking antidepressants are at increased risk of suicidal behavior and thoughts when taking the medication, cautions a boxed warning; they should be monitored closely. Safety and effectiveness has not been established in children. Abilify MyCite is also not approved to treat older patients with dementia-related psychosis.
