FDA Approves Pill with Sensor having a Digital Ingestion Tracking System

The U.S. Food and Drug Administration on Monday has approved for the first drug in the U.S. having a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets have an ingestible sensor embedded in the bill) that records that the medication was taken. The tablet is approved for adults in the treatment of schizophrenia, acute treatment of manic and mixed episodes, bipolar disorder and depression.

The pill’s sensor sends a message from the system to a wearable patch, which then the patch transmits the information on digestion to a mobile application that allows patients to track their medication on their smartphones.

Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said, “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients”

It is important to note that Abilify MyCite’s prescribing information says that the ability of the product is not approved for use in elderly patients, and the drug makers warn that those who have dementia-related psychosis and are treated with antipsychotic drugs are at an increased risk of death and to improve patient compliance with their treatment regimen has not been shown.

The statement Abilify MyCite also cautions should not be used to track drug ingestion in “real-time” or during an emergency because the detection may be delayed or may not occur.

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Abilify MyCite was first approved by the FDA to treat schizophrenia in 2002, and the sensor on Abilify MyCite was approved in 2012 for marketing.

Schizophrenia is a chronic, severe, and disabling brain disorder, but the exact cause of schizophrenia isn’t known. In Americans, about 1% has this illness. Typically, symptoms are first seen in adults when the body undergoes hormonal and physical changes (like those that occur during puberty in the teen and young adult years) or after dealing with highly stressful situations. Symptoms of Schizophrenia are described by disorganized speech or behavior and decreased participation in daily activities, thoughts that seem out of touch with reality. Loss of concentration and memory may also be present.

Bipolar disorder is described as a brain disorder and it is known as manic-depressive illness, but the exact cause of bipolar disorder isn’t known. Bipolar disorder causes activity levels, energy and the ability to carry out day-to-day tasks, unusual shifts in mood. The symptoms of bipolar disorder include manic episodes and Depressive episodes. Manic episodes symptoms such as high energy reduced the need for sleep and loss of touch with reality. Depressive episodes symptoms such as low energy, low motivation, and loss of interest in daily activities. Mood episodes that last days to months at a time and also be associated with suicidal thoughts.

Abilify MyCite is unauthorized to treat patients with dementia-related psychosis and it includes a boxed warning alerting healthcare professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The boxed warning also alters an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. The safety and efficacy of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and the emergence of suicidal thoughts and behaviors. Abilify MyCite should be dispensed with a patient medication guide that explains information about the drug’s uses and risks.

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In adults, the most common side effects reported by taking Abilify were uncontrollable limb and body movements (akathisia), vomiting, constipation, headache, nausea, dizziness, anxiety, insomnia, and restlessness. In some patients, skin irritation at the site of the MyCite patch placement may also occur.

Before patient using the product, the patient’s health care professional should facilitate the drug usage, patch, and app to ensure whether the patient is capable and willing to use the system.

FDA approved Abilify in 2002 to treat schizophrenia. In 2012 the ingestible sensor used in Abilify MyCite was permitted for marketing for the first time by the FDA. Proteus Digital Health made the sensor technology and patch.

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