Gov't approves first-ever med with digital tracking system

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When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor.

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

The sensor in the pill is the size of a grain of salt, with no battery or antenna.

The pill, Abilify MyCite, is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults.

Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed.

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.

Today, the Food and Drug Administration (FDA) approved the first US drug with a digital ingestion tracking system. In children, it warns of higher risks of suicidal behavior and thoughts.

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.

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

An anti-psychotic drug containing a digestible sensor which can alert doctors to whether a patient has taken the medication has been approved by the US Food and Drug Administration (FDA).

Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions. "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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