Get Ready for Digital Pills: FDA Clears Self-Tracking Drug

FDA approves the first pill that can alert your doctor when you swallow it

FDA approves the first pill that can alert your doctor when you swallow it

The U.S. Food and Drug Administration approved a joint application by Proteus Digital Health and Otsuka Pharmaceutical for a medication monitoring tool for patients taking Otsuka's drug Abilify.

Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders.

Abilify MyCite contains a Boxed Warning to alert healthcare professionals not to treat patients with dementia-related psychosis. Abilify was approved ten years earlier. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify 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". Skin irritation at the site of the MyCite patch placement may occur in some patients.

Patients wear a patch over their torso, which relays a signal between the drug pill and the mobile app. With the patient's consent, that data can then be shared with a doctor and family members to help manage the mental illness, Proteus has said in past statements, lobbying for the FDA to approve the drug.

The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology.

The FDA approval came with some caveats regarding the technology's limitations, though.

Notícias recomendadas

  • Japan's SoftBank may secure stake in Uber

    Japan's SoftBank may secure stake in Uber

    But SoftBank refused to confirm the news when contacted by AFP and said it was not planning to issue any statement on Sunday. The Benchmark-Kalanick lawsuit is almost dead, but this isn't a clear victory for Uber's ex-CEO.
    Rumor: Amazon Developing a Free, Ad-Supported Streaming Service

    Rumor: Amazon Developing a Free, Ad-Supported Streaming Service

    While Netflix continues to be my first stop for something to watch on a lazy evening, Amazon tends to fill in a lot of gaps. Amazon is reportedly seeking travel, cooking, and lifestyle shows for the service, along with new children's programming.

    APG Asset Management NV Cuts Stake in Continental Resources, Inc. (CLR)

    If you are viewing this article on another publication, it was stolen and reposted in violation of U.S. and global copyright law. Finally, IndexIQ Advisors LLC bought a new stake in shares of Continental Resources in the 2nd quarter worth $210,000.
  • Cowboys likely without Sean Lee for 2-3 weeks

    Cowboys likely without Sean Lee for 2-3 weeks

    Lee has battled hamstring problems all season long, and even when he was on the field in recent weeks, he could often be seen limping around.

    Senators Reach Deal to Ease Post-Crisis Rules on Some Banks

    The Senate proposal would phase in the increase over 18 months, though banks with less than $100 billion in assets would get immediate relief.
    A gang on mopeds ransacked Apple's flagship London store

    A gang on mopeds ransacked Apple's flagship London store

    One customer Hajra Ali, 37, from Ilford, said: "Moped attacks have got really, really bad and I'm not surprised this happened". The Metropolitan Police were alerted to reports of a robbery at around 12:45 a.m. on Monday, Nov. 13, according to Sky News .
  • Robbers Dig in Tunnel Into Bank, Loot 27 Lockers

    Robbers Dig in Tunnel Into Bank, Loot 27 Lockers

    Since then, they reportedly dug the tunnel which stretched to 25-feet, to reach the locker room of the Bank of Baroda branch. The accused allegedly opened 30 of the 225 lockers there, and walked away with valuables worth about Rs 40 lakh.
    Emily Maynard Welcomes Baby #4 - See the First Pics!

    Emily Maynard Welcomes Baby #4 - See the First Pics!

    The proud parents also share sons Gibson Kyle , 11 months, and Jennings Tyler , 2. "We need help!", she wrote on Instagram . Another commentor added, "I think Maddox would go really well with your other boys names".
    Victoria writer Daisy Goodwin claims she was 'groped' during Downing Street visit

    Victoria writer Daisy Goodwin claims she was 'groped' during Downing Street visit

    Daisy Goodwin, creator of ITV royal drama Victoria , said she was pestered by the aide when David Cameron was prime minister. The official, "who was a few years younger than me", showed her into a room dominated by a portrait of Margaret Thatcher.
  • Sessions Considering Second Special Counsel into Clinton

    Sessions Considering Second Special Counsel into Clinton

    Goodlatte took particular aim at former FBI Director James Comey, asking for a second special counsel to evaluate the leaks he directed about his conversations with President Trump, among other things.
    Disturbing Tom Sizemore Allegation, Involving 11-Year-Old Co-Star, Surfaces

    Disturbing Tom Sizemore Allegation, Involving 11-Year-Old Co-Star, Surfaces

    Sizemore has said for years that his drug problems, including a 2007 arrest for methamphetamine possession, began as a teenager. Actor Tom Sizemore has been accused of molesting his 11-year-old co-star in a bombshell report by The Hollywood Reporter .

    Intl Fcstone Inc. Acquires Shares of 4013 Texas Instruments Incorporated (TXN)

    With the existing current ratio, Texas Instruments Incorporated is more than equipped to confront its liabilities with its assets. In other news, insider R Gregory Delagi sold 238,750 shares of the business's stock in a transaction dated Monday, November 6th.

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.