FDA approves first 'trackable' pill Abilify

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

The U.S. Food and Drug Administration has given the nod to Abilify MyCite, for use in patients with schizophrenia, an add-on treatment for depression, and to help control episodes of either manic or "mixed" episodes for people with bipolar disorder. Once ingested it's able to send a message from the sensor packed into the pill to a wearable smart patch that's worn on the rib cage. In the app, patients can track medication adherence and give access to the data to caregivers and physicians.

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

USA regulators have approved the first drug with a sensor that can track whether patients have taken their medicine.

And psychiatrist Dr. Peter Kramer, who wrote "Listening to Prozac", said drugs like Abilify Mycite come with a built-in "tattletale".

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"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. The atypical antipsychotic drug is already available as a cheap generic, and doctors are already using an injectable, long-lasting version-Abilify Maintena-to manage patients who have problems sticking to a daily pill regimen. The drug is now not approved to treat these patients, according to the FDA. 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. The FDA advises that patients should be monitored for this condition.

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 pill is embedded with a tiny sensor about the size of a grain of sand that lets doctors know if and when a patient has taken their medication.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence". "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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