U.S. approves digital pill that tracks when patients take it

U.S. approves digital pill that tracks when patients take it

U.S. approves digital pill that tracks when patients take it

USA regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

This digital pill is a version of the drug "Abilify" made by Otsuka Pharaceutical which treats schizophrenia, bipolar disorder and depression... with the added tracking device developed by Proteus Digital Health.

"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", Mathis said.

An ingestible sensor embedded in the pill is able to record that the medication was taken - sending signals to a wearable patch that then transmits the data to a mobile app. Additionally, patients must be willing to allow their doctors and caregivers to access the digital information.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency", the statement said, "because detection may be delayed or may not occur".

Teens and young adults who are taking antidepressants are at increased risk of suicidal behavior and thoughts when taking the medication, cautions a boxed warning; they should be monitored closely.

The safety and effectiveness of the mediation has not been established in children.

The FDA said that while the system can track doses, it hasn't been shown to improve patient compliance.

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%.

The FDA stressed however that there are limitations to monitoring patients.

Intended for use in patients with schizophrenia or bipolar disorder in which the regular follow-up treatment is very important, it contains a sensor that can measure the dates and hours of the outlet.

In clinical trials, the most common side effects reported by adults were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

Although there are still some hurdles to overcome, the digital pill could completely transform the way in which mental illness is treated, thanks to modern-day and complex technology. The medication without the sensor technology was first approved to treat schizophrenia in 2002. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The drug itself, Abilify, manufactured by Otsuka Pharmaceuticals Co. Proteus Digital Health, based in Redwood City California, makes the sensor.

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