United States regulators approve first digital pill to track patients

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About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill has the potential to improve public health, but warned it could foster more mistrust if used improperly.

The medicine is a version of Otsuka Pharmaceutical Co Ltd's established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.

Abilify MyCite works by sending a message from the pill's sensor to a wearable patch, which then transmits the information to a mobile application, letting the patient track the ingestion.

Abilify on its own had received FDA's approval in 2002 for the treatment of schizophrenia. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed. Data from the tracker can be kept private for the patient alone to see, with the option to share data with healthcare professionals or other individuals, if desired.

Patients are given the option to sign a consent form allowing their doctor and up to four family members or care-givers to receive information about when the pills were taken. Medication adherence is a problem when treating patients with severe mental health disorders, because patients may not like side effects or may stop taking medication once they feel better. In general, communication between the pill, patch, and app are delayed, and data are not available in "real-time", according to the FDA. The product includes a boxed warning noting that older adults with dementia-related psychosis treated with antipsychotic drugs are at a higher risk of death. Skin irritation at the site of the MyCite patch placement may also occur. The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.

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