FDA approves first digital pill

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The Abilify MyCite aripiprazole tablets - for treating schizophrenia and manic episodes - have an ingestible sensor embedded inside them that records that the medication has been taken.

But until now, the FDA had not approved a sensor-pill combination.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

FDA approved Monday a drug with a digital ingestion tracking system.

This allows patients can track their meds on their smartphone; it also enables caregivers and physicians to access adherence through a web-based portal, when given permission. 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.

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Experts hope it could improve medication compliance, although the company that makes the tablets says this has not been proved for their product.

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. The drug is now not approved to treat these patients, according to the FDA. In addition, the boxed warning points to an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

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. Skin irritation may also occur due to the MyCite patch, according to the release.

The system could be used to manage patients who have long, complex medical routines in the future.

In a portion of the statement that appeared to address privacy concerns, the FDA said the wearable patch that comes with the medication "transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone". By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER". "Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug".

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