US FDA approves first drug with digital ingestion tracking system

US FDA approves first drug with digital ingestion tracking system

The sensor in Abilify MyCite is ingestible and can also record when the patients had taken the pill.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, and was subsequently rejected, with a request from the FDA for more information on the digital drug. "Patients can also permit their caregivers and physician to access the information through a web-based portal". The FDA said in a statement Monday that the digitally-enhanced medication "works by sending a message from the pill's sensor to a wearable patch".

Abilify MyCite has been approved for treating schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and also an add-on treatment for depression in adults.

The FDA warns that label claims suggesting aripiprazole tablets with sensor may improve medication adherence have not been proven. "Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or not occur", a statement from the FDA said.

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.

"Being able to track ingestion of medications prescribed for illness may be useful for some patients", said Dr. Mitchell Mathis, director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. The drug is now not approved to treat these patients, according to the FDA. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

The most common side effects of aripiprazole include nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

The system could be used to manage patients who have long, complex medical routines in the future. FDA said Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence". "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".

Related Articles

  • Saudi-Led Coalition Refuses to Re-Open Key Yemen Port

    Saudi-Led Coalition Refuses to Re-Open Key Yemen Port

    Noting that there were three weeks of vaccines left in the country, McGoldrick said "humanitarian supplies are dangerously low". McGoldrick was speaking to reporters in Geneva by phone from Amman, because he said flights into Sanaa were blocked.
    ASI Hassan getting massage from a woman home guard

    ASI Hassan getting massage from a woman home guard

    Deputy Inspector General of Police, Hyderabad Range, M Stephen Raveendra has confirmed the reports of the ASI's suspension. This is the second such incident reported from the state in the past couple of weeks.
    Android 8.1 Appears Set to Reduce Inactive App Size, Saving Device Storage

    Android 8.1 Appears Set to Reduce Inactive App Size, Saving Device Storage

    According to the code first spotted by XDA-Developers, Android 8.1 will make apps inactive that haven't been used in a while. This chart is an indication of what version of Android is running on how many devices in the market in terms of percentage.
  • Commissioner says Conor McGregor off UFC 219 card after 3 Arena incident

    Commissioner says Conor McGregor off UFC 219 card after 3 Arena incident

    Although a fight has yet to be officially confirmed, De La Hoya has said he is willing to take on the Irishman in the ring. Oscar De La Hoya is looking to fight Conor McGregor if he makes a comeback to boxing.
    Jailed Ram Rahim Enjoying VIP Perks, Alleges Prisoner. Minister Denies It

    Jailed Ram Rahim Enjoying VIP Perks, Alleges Prisoner. Minister Denies It

    He claimed that the situation improved somewhat when a prisoner approached a judge, who pulled up the jail administration. On Monday, the family members of Ram Rahim once again visited him at the jail.
    Amazon's denies Cloud leaves China

    Amazon's denies Cloud leaves China

    Microsoft Corp, Oracle Corp and IBM Corp are also facing tough new regulatory challenges in localizing their data storage units. Amazon's cloud business in China already faced tougher rules due to China's tight internet controls.
  • Bank of England reveals last day to use old £10 notes

    Bank of England reveals last day to use old £10 notes

    The Bank of England says they are also an improvement on the previous version in terms of security and durability. The new notes are the first to have a tactile feature that helps blind and partially sighted people.
    Chelsea legend Didier Drogba confirms retirement plans

    Chelsea legend Didier Drogba confirms retirement plans

    The 39-year-old powerhouse made over 380 appearances for Chelsea over two stints, scoring 157 goals. He added, " At some point you have to stop".
    Women, revamp your diet today. You're more prone to diabetes

    Women, revamp your diet today. You're more prone to diabetes

    Clare (not her real name), 26, says she had to quit her job as a management consultant as a direct result of her diabetes. With 72.9 million people now living with diabetes , India is known as the world capital for the disease.
  • Overwatch Getting 4K Support for Xbox One X

    Overwatch Getting 4K Support for Xbox One X

    It starts at 7pm United Kingdom time on Friday and ends at 7.59am United Kingdom time on the morning of November 21. Moira is a support hero and she is able help her allies with abilities that can both heal and cause damage.
    Amazon Music App now supports Chromecast

    Amazon Music App now supports Chromecast

    You can sign up to Amazon Music Unlimited here , and go whole-hog with a Prime membership here . The company is also bringing several curated photo themes.
    Parents warned of 'worrying' security risks in Christmas 'smart' toys

    Parents warned of 'worrying' security risks in Christmas 'smart' toys

    The I-Que Intelligent Robot, has previously featured on Hamleys top toys Christmas list and is available from Argos and Hamleys. It was found that hackers could send their own voice messages to the toy, and receive the replies from the child.