FDA approves pill with digital tracking device you swallow

America Pharmaceutical Inc. shows a rendering of the packaging for Abilify MyCite. AP

America Pharmaceutical Inc. shows a rendering of the packaging for Abilify MyCite. AP

The first drug created to alert a doctor when a patient takes the medication has been approved by the U.S. Food and Drug Administration.

The medication from Japan-based Otsuka Pharmaceutical Co is meant to treat schizophrenia, bipolar I disorder and depression in adults.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in the FDA's statement. "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". This allows the patient and doctor to track the medication's use via smartphone. And the drug should not be used in an attempt to track real-time ingestion since detection could be delayed, the agency added.

The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%.

"I can see how Abilify MyCite would be a win for advocates of forced treatment and their misguided notion that med compliance will reduce acts of violence", Caseres said.

ABILIFY MYCITE, however, has not been approved for the treatment of patients suffering from dementia-related psychosis or in case of pediatric patients. It could also be used to monitor whether patients have taken an excessive amount of medication following operations and procedures.

That's a lot of moving parts, but the problem it aims to address is a real (and expensive) one: nonadherence, which is the term for patients not following through with prescribed treatment.

The most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body, anxiety, insomnia, and restlessness.

Some health experts were surprised that the first digital drug to be approved by the FDA is an antipsychotic, because some people who have schizophrenia experience paranoia and delusions that they are being watched.

Abilify MyCite's approval was granted to Japan's Otsuka Pharmaceuticals. The company anticipates that information will be available in 2018, "closer to when our initial rollout commences". The CEO of Proteous Digital Health, Andrew Thompson, said "this technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way". The drug tracking system is the first of its kind in the U.S.

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