FDA Approves First Digital Pill

The Associated Press reports:

U.S. regulators have approved the first drug with a sensor that can track whether patients have taken their medicine. The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012. 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.”

“Being able to track ingestion of medications prescribed for illness may be useful for some patients,” Dr. Mitchell Mathis of the FDA said in statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers.” Abilify MyCite was developed by Otsuka Pharmaceutical Co. and the sensor was created by Proteus Digital Health.

The New York Times reports:

Patients who agree to take the digital medication, a version of the antipsychotic Abilify, can sign consent forms allowing their doctors and up to four other people, including family members, to receive electronic data showing the date and time pills are ingested.

A smartphone app will let them block recipients anytime they change their mind. Although voluntary, the technology is still likely to prompt questions about privacy and whether patients might feel pressure to take medication in a form their doctors can monitor.

Dr. Peter Kramer, a psychiatrist and the author of “Listening to Prozac,” raised concerns about “packaging a medication with a tattletale.” While ethical for “a fully competent patient who wants to lash him or herself to the mast,” he said, “‘digital drug’ sounds like a potentially coercive tool.”

  • Xiao Ai: The Social Gadfly

    Because, who needs privacy besides the rich?

  • Boreal
  • bkmn

    The joy of having to take chronic medications. I have three pills I need to take in the morning and one in the evening. What helps me to remember to take the right drugs is I invert the pill bottles of the morning drugs when I take the evening drug and invert the bottle of the evening drug in the morning. When I take the drug I flip the bottle(s) upright so I can see I took the days meds.

    • Harveyrabbit
      • marshlc

        Only if you remember to fill them….

        I like the idea of flipping the bottle. Can’t tell you how many times I’ve stood in the bathroom, looking at a pill bottle, and thinking “I remember taking it, but am I remembering yesterday, or today?”

        • Todd20036

          There is also an app on an iPhone.
          Once a week I fill my pill dispenser. I take 3 pills a day – one is the HIV thing, the other 2 are for lesser ailments.
          At the end of the week, I fill the dispenser for the next 7 days.
          It’s a good habit.

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      • ted-

        I have one for my supplements. It’s much more cost effective than their pill

      • This is what I used. I have to take four pills a day —fortunately, all in the morning, no food restrictions, so I can take them all at once. I refill mine on Saturdays after I’ve taken my last set for the week, or sometimes on Sundays before starting the new week.

      • Hue-Man

        I was going to use one but was told that I had to leave the med in the bottle with the desiccant.

        • Harveyrabbit

          I live in a generally dry climate so that’s not an issue. Also depends somewhat on the specific med. Some are more prone to absorb moisture than others. Also a steamy shower/bathroom would be a bad place for that.

    • Michael White

      I st the alarm on my phone to remember PM med

      • another_steve

        ^^ I know other people who do that too. An excellent idea.

        • jmax

          My partner does that. Then he shuts off the alarm and forgets to take the pill anyway :^|

          • I’ve done that so many times myself. I’m usually very compliant…but if the alarm goes off and I’m not near the pills they can be forgotten. Thankfully a missed dose now and then isn’t a huge deal.

          • jmax

            My hubby takes esomeprazole for acid reflux so it’s not exactly life threatening when he misses a dose. I do find the alarm on his phone to be rather annoying though 🙂

    • another_steve

      I find that a strict and robot-like routine – no variation whatsoever – works best for me.

      One pill I take first thing when I get out of bed in the morning and go piss. One pill I take right before dinner. The others I take just before shutting the bathroom light off at night and getting into bed.

      The key for me is a strict routine – no thought or “memory work” involved or needed.

      • Marty Pavelka

        My parents, who are in their 90’s, take little meds but they do have a regimen that they follow to remember the evening and morning pills. My sister and brother in law would like my Mom to switch to an electric, timer-run, dispenser unit. I am not that on board with this idea, as I think it would be disruptive to their routine and confusing to them. Plus, electrons. They tend to mess up TVs enough that I’d be concerned about them messing up the dispenser.

        • Hue-Man

          “If it ain’t broke, don’t fix it.”

        • another_steve

          Hear ya.

          My mom (may she rest in peace) was technologically totally not with-it. My sister and I tried for years to get her to apply for a bank ATM card. To spare her from having to stand on line in the bank. She wouldn’t hear of it. “Too complicated. Who needs it.”

          I agree with what Hue-Man said here: “Ain’t broke, don’t fix it.”

    • iambu

      That’s a smart idea. I personally rely on the withdrawal symptoms, but probably doesn’t work for everybody’s meds.

    • Grumpy Old Man

      I never forget my night meds (else I do not sleep) so I have 2 little cups on my night stand. In the evening I fill each then take the evening meds – when I wake up, I take the morning meds – before i leave for the day, I check to see if both cups are empty. Every once in a while, I see pills in the morning cup and take them if I caught it early enough. A couple of my meds are twice a day but most are one or the other.

  • clay

    “I’m sorry, your digital record of taking your court-ordered medication has been hacked. Please stay on the line to speak with an operator. I’m sorry, your . . .

    • boatboy_srq

      “Senator, would you care to comment on the latest Wikileaks data dump regarding your misuse of Oxycontin and Viagra?”

      • lattebud

        “I was hacked by Hillary. Or George Soros. Or Rachael Maddow. Or the Russians”

      • JohnInCA

        … Oxycontin and Viagra? Eh, who would care.

        Nah, things like Abilify are where the “scandals” really come into play. Who doesn’t want to know which politicians or movie stars are on anti-psychotics?

  • Harveyrabbit
    • Silver Badger

      I use mine every day. However, I don’t ever purposely go off my meds.

      • iambu

        Me neither. I learned the hard way twice. I think it’s the twice part that’s really stupid…

    • clay

      I use one when traveling– it and the prescrip forms take up less room than all the bottles, and I’m seldom gone for more than a week.

    • I have several with the one for bedtime on the night stand.

    • Treant

      I have one, too. But my regimen is so easy that I take one from every bottle (very few). At night, the one I take then, I simply turn the bottle over to tell myself I took it.

    • Jean-Marc in Canada

      Same here, though I have the AM/PM version…and yeah, about 2 bucks at the dollar store.

    • JohnInCA

      This kind of pill & sensor isn’t really useful for people that are good at taking their medication regularly. They’re for people that are forgetful or liars. I mean, it’s not like schizophrenics and bipolar folks are notorious for not taking their pills and lying about it or anything.

  • clay

    I can see this technology also being applied to court-ordered antibiotics for tuberculosis.

    • Grumpy Old Man

      YES! Way better and cheaper than confining them or sending people out to look for them. I read up on the how/why of super TB – people stop when they feel better and sell the rest of their meds to people who self-identify or just want to make sure they don’t get TB.

  • Natty Enquirer

    What makes this medicine “digital” is the inclusion of the Proteus ingestible sensor, which sends signals to the receiver patch. Hmm, wonder how they came up with that name?

    • (((GC)))

      Much more:

      “The sensor, containing copper, magnesium and silicon… generates an electrical signal when splashed by stomach fluid, like a potato battery…

      After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced after seven days…

      The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app. The app allows patients to add their mood and the hours they have rested, then transmits the information to a database that physicians and others who have patients’ permission can access.”

      The article also mentions competing technologies — etectRx’s ID-Cap, whose detector need not be a patch, and AiCure, a smartphone app that uses the camera and works with regular medications — and gives a variety of reactions to “biomedical Big Brother”. For example, some patients might accept it in order to build trust with their psychiatrist.

  • netxtown

    oh hell no. I’ll be damned before i share my innards with google….

    • So many already share that with grindr.

  • fuow

    Anyone who has seen the quality of life improvements these medications offer to people with treatable mental illness is going to see the positive gains outweigh the violation of privacy.

    • boatboy_srq

      Replace “treatable mental illness” with “HIV”; still acceptable?

      And how many patients on this regimen will not face discrimination in employment, or housing, or services, if this information were to become public?

      • fuow

        There are medications for which this technology is appropriate and medications for which this technology is wildly inappropriate.
        Instead of the faux ‘privacy’ we currently have in the US under the stupid HIPAA regulations (which only serve to make life difficult for the patient and everyone else), we need medical privacy guidelines which genuinely protect the patient’s privacy.
        Arguing against a technology which can really help a lot of people in treatment because it can be abused is not valid or sound. Whether it is the modern synthetic opioids or this sort of regime tracking, denying patients effective treatment because some people will find ways to abuse it is not the answer. Work on preventing abuse, not denying treatment.

        • boatboy_srq

          If the technology can be abused -and ALL technology can be abused – then propriety doesn’t enter into it. “You’re fired because you didn’t take your meds today”, or “we are not hiring / leasing to / serving you because you’re on prescription X” are both likely outcomes from this tracking, regardless of the security promised by thr manufacturer.

          • fuow

            Well, yes, indeed-y. All technology can be abused. So – do we liberals want to be part of the discussion and make things as sane and useful as possible for the patient or do we want to scream ‘fails my purity test!’ once again, yet again and let the mother-fucking christers and rethugs decide how this will be use?
            It will, you see, be used. That’s the promise and curse of technology.
            I’m all for us working to direct new technologies (or new applications of old technologies) to serve us, you seem to be arguing along the same lines as the anti-PrEP folks?

  • netxtown

    will these pills know when i am …well, ya know…when i am choking the chicken?

  • Dan M

    Maybe we could put these sensors in assault rifles so that it registers every time one is picked up.

  • KCMC

    Clinical soc wkr, I’m super ambivalent (pardon pun) as about 1/2 caseload of youth on this med.
    Is prescribed for range of adolescent challenges: It can treat schizophrenia, bipolar disorder, depression, and Tourette syndrome. It can also treat irritability associated with autism.
    Folks can suffer so when off meds, but tracking seems questionable for so many reasons. Esp for low tech/ no smart phn patients whom would be numerous of those treated.

  • djcoastermark

    Even better now that you can follow your pills’ journey in real time, by using your smart phone’s GPS tracking.

    • iambu

      Oh look! It’s nearing my duodenum! This is my favorite time of day! Honey, get the camera!

      (I mostly just wanted to write “duodenum…”)

      • djcoastermark

        Yes, but, do we need um ? 🙂

        • iambu

          THAT camera? 😉

  • BlindBill

    Court ordered chemical castration for pedophiles ….

  • SkokieGuy [ChicagoAdjacentGuy]

    Abilify, the powerful anti-psychotic medication that’s now widely used to treat depression. From April 2013, through March 2014, sales of Abilify (official name, aripriprazole) totaled $6,885,243,368—that’s right, almost $6.9 billion. That’s more than all other major anti-depressants combined.

    And yet, the FDA says that the way Abilify works is “unknown.” Unknown! As in, we have no idea why this medication seems to help people with bipolar disorder. But go ahead and try it anyway, since it seems to work somehow.


    • iambu

      I’ve used it for bipolar. It wasn’t fun. Worst tremors I’ve ever had. One drink and I’d be almost passed out (so I just stopped drinking at all, for a few months), and ultimately not effective for me. A friend used it for about a year to help with treatment resistant depression. He got the loss of impulse control and weight gain side effects that missed me but messed him up big time. His weaning/withdrawal experience a few months ago was really difficult. I’m not super bothered by the “unknown” thing. I mean, I don’t love it and it kinda creeps me out, but if you’ve been on the medication carousel with psych meds long enough, and something comes along that just works, it’s pretty easy to just go with it. Still, I have yet to hear anyone share a positive experience with Abilify. It’s really not as gentle a drug as advertised (I mean none of them are, but still…and also, I continue to find it freaky that we make TV commercials for meds, but that’s its own rant).

    • Treant

      That’s kinda true with most meds that are psychologically active, isn’t it? We know that they work. We know side effects. But the precise mechanism is only a guess…

  • Tatonka

    Ugh. I wonder how long it will take until medications require a Comcast subscription.

    • Jon Doh

      My Comcast service replaced my laxative.

      • Jean-Marc in Canada

        Yeah, I hear Comcast is quite a bowel movement inducer.

  • marachne

    Definitively troublesome, but also I can see the attraction. I wonder if they did this in part because they are losing market to Risperidone (Risperdal). This drug is truly amazing – people I know in MH say that it has completely turned people’s lives around, stabilizing them and letting them function at a higher level then anything else they have been on. And it’s available as a injection good for 2 weeks, so that takes care of a lot of the adherence problem.

  • Jacob

    Observed compliance has worked in the past for tuberculosis but the marking and tracking of humans has almost always led to confinement and death.

  • Bj Lincoln

    I take 13 pills in the morning, 7 in the afternoon and 8 at night. 5 are a cocktail of pain pills 3 times a day so its not hard to remember to take them. The rest are heart related that make me sick no matter what I do. Making sure the in-law takes his is a big problem so the digital pills would help us track his pills.

  • Willys41

    The problem of course is people who need to take medication for serious mental diseases but stop taking the medication because after taking the medication they feel just fine–which begins the downward spiral that can have disastrous consequences.

  • This is a bit OT — I was able to get off regular visits to the doctor for hypertension -and three strong meds (my blood pressure was measuring 190/120 at one time) by following his advice and refusing to answer telephone calls from my belligerent older sister regarding the care of my mother. We do emails now. My blood pressure is down to a manageable 135/82 and we are working on getting it lower. He experienced what she was like one afternoon when she called him and howled at him with threats– he told me he will never again take her calls. Just removing stressful people and situations from your life can do wonders for your health and psychological condition, holistic remedies can work also. Care providers are at frequent risk for type of secondary exposure.

    Family: You’re just paranoid.
    Patient: My pills are talking to you.
    Family: That’s crazy!

  • OCW

    The doctors I have seen over the last several years barely have time to talk to me due to how the clinics have reduced staff and other issues to save $$. I doubt my current doctor (soon to be ex-doctor) could stay on top of monitoring whether meds are taken or not. Not sure about the nuts and bolts of notification…

  • Ken Berry

    I generally do fine with the pills, but I sometimes can’t remember if I’ve injected my insulin!

  • Platos_Redhaired_Stepchild

    For chronic illnesses, I’m surprised drug manufactures don’t make medication implants like they do with birth control ( Nexplanon ). A matchstick under the skin lasts 3 years. It would be nice to have that option for other medications.


  • Patricia Garvin Fox

    This could be very useful in a public health setting such as treatment of tuberculosis. If, of course, patients were cooperative enough. Perhaps it might allow things like methadone to be dispensed more easily. It would also be potentially helpful for those with cognitive or memory issues.

    For me, a double pillbox for morning and evening does the trick. I hate the weekly ritual of filling it but it sure beats twice a day.