FDA approves smart pill that lets doctors know when it's been swallowed

FDA approves the first pill that can alert your doctor when you swallow it

Smart pills are a thing and they've come one step closer to entering the mainstream after the FDA approved a pill packed with a digital sensor for the first time in the US.

The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia.

The Japanese drug maker Otsuka Pharmaceutical won the approval for an upgraded version of Abilify, the antipsychotic drug first approved 15 years ago to treat schizophrenia, bipolar disorder, and depression.

Abilify MyCite must be dispensed with a patient medication guide that describes important information about the drug's uses and risks.

This technology might work better for different medications, like antibiotics where it's crucial that the patient finish the dose, or medication for elderly patients who might need help remembering to take their pills. This is picked up by a wearable patch-worn on the left rib cage and replaced after seven days-which then sends the information to a smartphone app that allows patients to track when they took their medication.

Otsuka shares rose 2.5 percent on Tuesday after news by the US Food and Drug Administration (FDA) late Monday.

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers".

Abilify MyCite's labeling information also notes the product's ability to improve treatment compliance in patients has not been proven.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur". Other warnings include an increased risk of possible suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

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