The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012 and was made by Proteus Digital Health. Additionally, the smart pill should not be used for real-time tracking or during an emergency since detection can be delayed or may not happen, according to the release.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, in a statement Monday afternoon. Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.
It can also be used in the acute treatment of manic and mixed episodes associated with bipolar I disorder so it has the potential to do a whole lot of good.
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.
In the case of Abilify, a patient who doesn't stick to the drug could end up in a psychiatric hospital, so Abilify MyCite may find its niche. In children, it warns of higher risks of suicidal behavior and thoughts.
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The most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body, anxiety, insomnia, and restlessness.
"H$3 aving fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients' experiences", the company said in its announcement.
FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER". "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".
The newspaper noted that similar digital drugs are being developed for a range of conditions, including heart disease, stroke, HIV and diabetes.