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FDA approves first ever 'digital pill'

16 November 2017

Big news for the health industry: United States regulators have approved a pill that can be digitally tracked through the body using an ingestible sensor and a patch worn by patients.

In combination though, the Abilify MyCite system was rejected by the FDA in April a year ago due to concerns over the possible impact of "human factors" on safety.

People who meet the criteria for Abilify MyCite can decide, along with their doctors and caregivers, whether this type of medication monitoring might help them manage their disease.

The treatment is called Abilify MyCite, which is meant to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use as an add-on treatment for depression in adults. For this digital pill combination, it partnered with Japanese drug maker Otsuka Pharmaceutical, which makes Abilify.

It might sound creepy, but USA regulators have approved a drug that can digitally track whether patients have taken their medicine.

Ms Wells said advances that safely and economically supported patients in taking their medicine as prescribed had significant benefits to the patient and the health system in reducing the pain and costs of avoidable illness.

The new digital pill works by relaying a signal from a tiny sensor embedded in the pill itself (which is activated by the liquid in the human stomach) to a wearable patch on the patient.

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The Abilify MyCite features a sensor the size of a grain of sand made of silicon, copper, and magnesium. Abilify MyCite should not be used to track drug ingestion in real time or during an emergency because detection may be delayed or may not occur, FDA stated.

In a historic move by the US Food and Drug Administration (FDA), the first ever digital pill has been approved for use.

Get the latest health and science news, plus: burning questions and expert tips. A patch the patient wears on their left rib cage receives the signal several minutes after the pill is ingested. The drug Abilify (with or without the digital sensor) can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements.

Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The system can also "help remind people with schizophrenia if they forgot to take medications", Birnbaum said.

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%. "[But] if used improperly, it could foster more mistrust instead of trust".

FDA approves first ever 'digital pill'