FDA Approves First Digital Pill, Antipsychotic Drug with Sensor that Tracks Consumption in Patients


Published Date : Nov 14, 2017

As per an agency announcement published Monday, the U.S. Food and Drug Administration (FDA) has given a green signal to an antipsychotic drug that bears a digital sensor capable of tracking whether patients are taking it. Abilify MyCite is the new drug that has been approved to treat maniac and schizophrenia episodes related to bipolar disorder. The sensor proactively sends a message to a wearable patch after the drug has reached the patient’s stomach after swallowing it. The wearable patch then conveys this information to a mobile app. This allows patients to track the consumption of their medication and forward the information to doctors or caregivers via an online site.

FDA Rejected Abilify 1.5 Years Ago Citing Lack of Clarity whether Human Error could Create Risks

Abilify MyCite has been supposed to be the first drug of its kind with a tracking system as explained earlier. It has been prepared in collaboration with the designer of the sensor, Proteus Digital Health and Otsuka Pharmaceutical. The drug’s labeling, however, notes that it is dubious whether patients would be likely to take the drug due to the app. On its own, Abilify has already been approved since 2002 but is currently off-patent. However, its version with the sensor has retained a black box warning, which means it could have some serious side effects according to the FDA.

Abilify’s label notifies that psychosis due to dementia patients could be at a high risk of death if they take the drug. Abilify MyCite, on the other hand, could raise the risk of suicidal behavior and thoughts in young people who take antidepressants and also teens and children.