Jennifer Gershman, PharmD, CPh
Jennifer Gershman, PharmD, CPh
Jennifer Gershman, PharmD, CPh, received her PharmD degree from Nova Southeastern University (NSU) College of Pharmacy in 2006 and completed a 2-year drug information residency. She served as a pharmacy professor at NSU’s College of Pharmacy for 6 years, managed the drug information center, and conducted medication therapy management reviews. Dr. Gershman has published research on prescription drug abuse, regulatory issues, and drug information in various scholarly journals. Additionally, she received the Sheriff’s Special Recognition Award for her collaboration with the Broward, Florida Sheriff’s Office to prevent prescription drug abuse through a drug disposal program. She has also presented at pharmacist and physician continuing education programs on topics that include medication errors, prescription drug abuse, and legal and regulatory issues. Dr. Gershman can be followed on Twitter @jgershman2

FDA OKs Digital Tracking-Pill System

NOVEMBER 13, 2017
Staff Report

Officials with the US Food and Drug Administration have approved aripiprazole tablets with a sensor to digitally track whether patients with schizophrenia, bipolar I disorder, and depression have taken their medication (Abilify MyCite). 


The sensor that is used along with aripiprazole was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a first for the FDA. The sensor in Ability MyCite syncs with a smart phone and sends an alert when the medication is ingested via a patch that is worn on the surface of the skin.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug. A resubmission of the new drug application was accepted by the agency in May 2017. 

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. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

Aripiprazole is approved with a boxed warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole marketed by Otsuka Pharmaceutical.

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