First digital pill to track patients taking medicine OK’d

WASHINGTON » U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

The digital pill approved Monday combines two existing products: the former blockbuster psychiatric medication Abilify — long used to treat schizophrenia and bipolar disorder — with a sensor tracking system first approved in 2012.

The technology is intended to help prevent dangerous emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder.

But developers Otsuka Pharmaceutical Co. and Proteus Digital Health are likely to face hurdles. The pill has not yet been shown to actually improve patients’ medication compliance, a feature insurers are likely to insist on before paying for the pill.