FDA Asks Diarrhea Treatment to Contain Itself

 

Over a year ago, I noted that both the DEA and NIDA had expressed concern over the diarrhea treatment loperamide, widely known by the brand name Imodium. Loperamide is an opioid that, with normal use, mostly stays in the gut where it belongs, but which, if it’s taken in massive doses or combined with a P-glycoprotein inhibitor, works its way into the bloodstream and crosses the blood-brain barrier for a pathetic sort of high. Or, if you believe methadone treatment works, the high becomes somewhat less pathetic: loperamide has gotten a reputation among addicts as the poor man’s methadone, a means of easing withdrawal for those done with the dope.

One reason methadone is supposed to work as an addiction treatment is that it’s metabolized so slowly. It has an extremely long half-life (15-55 hours) compared to heroin’s (2-3 minutes). This smooths out the highs and lows to help those treated establish a normal life. Since methadone treatment is dispensed at clinics, not by pushers, it redirects addicts’ dependency toward authorized channels, which regularizes their life in another way. Loperamide has a half-life between heroin’s and methadone’s (9-14 hours). That half-life makes loperamide tempting as “DIY methadone treatment”.

Because both methadone and loperamide are longer-acting drugs, it’s tempting for someone impatient for their effects to kick in (as impatient, maybe, as a heroin addict) to take more and overdose, resulting in an overdose that’s harder to treat. Since methadone isn’t legally available outside of clinics, it’s not possible to overdose on methadone legally. The same can’t be said for loperamide: when used to calm rumbly guts, loperamide is such a safe and useful drug that its supply has so far been unrestricted. But that’s changing. The FDA has just called for more restrictive packaging of loperamide in order to thwart addicts:

The FDA has asked J&J to reduce the number of caplets in over-the-counter retail packages of Imodium to provide for short-term diarrhea treatment, a move would be followed by makers of generic versions of Imodium.

FDA Commissioner Scott Gottlieb called the agency request “fairly unprecedented” in a statement on Tuesday and said those restrictions could constitute a two-day supply, or a maximum of eight two-milligram pills. J&J was noncommittal.

The steps to limit Imodium are part of a broader FDA effort to stem the tide of overdose deaths. More than 42,000 Americans died from opioid overdoses in 2016, according to the Centers for Disease Control and Prevention.

The FDA is also considering whether it can use packaging to stem access to certain fast-acting opioids such as Vicodin and Percocet that are meant for short-term use, Gottlieb said. For example, doctors may opt to prescribe fewer pills if such opioids were packaged in three- or six-day blister packs, he said.

Soon, retail packages may only carry a two-day supply of loperamide, each dose encased in a fiddly little blister pack. It’s unclear what will happen to online vendors. Gottleib reasons,

“If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books,” Gottlieb said. “You have a social contract to take voluntary steps to help address public health challenges.”

Ten deaths from loperamide use were reported to FDA from its approval in 1976 through Dec. 14, 2015. The agency hasn’t updated those numbers, but it says abuse of the drug is on the rise.

“On the rise” from only ten deaths in a nearly forty-year period could mean many things. I wonder what counts as an alarming rise.

I also wonder if limiting the availability of “the poor man’s methadone” is such a great idea. First of all, asking loperamide to contain itself makes it harder for law-abiding citizens with gripey guts to contain themselves. But additionally, methadone treatment is expensive and cumbersome; while cheap, accessible loperamide as “DIY methadone”, despite its risks, allows for affordable self-treatment.

Admittedly, methadone treatment is cumbersome by design. When addicts use loperamide as a methadone substitute, part of the problem is that they’re doing it themselves: druggies aren’t exactly the type you would trust with self-treatment. Nonetheless, having self-treatment available is often better than not having it available.

Our state limits sales of pseudoephedrine (Sudafed) to two packages a day. You show the pharmacist your ID and sign a registry. It’s annoying, but often not very cumbersome. (I hear that changes when a parent has to buy for a whole family with sinus problems.) Even so, many of us wonder, why should law-abiding people be encumbered at all? Is it right? Is it worth it?

Where loperamide is concerned, these questions may be even more urgent. After all, how long do you wanna hafta stand in line for the pharmacist for your measly two-day supply while the thunder rolls?

Published in Healthcare
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  1. GLDIII Reagan
    GLDIII
    @GLDIII

    Snakes….Playing loose with the headline copy.

    • #1
  2. TBA Coolidge
    TBA
    @RobtGilsdorf

    When this sort of thing is lofted I am transported back to primary school where ‘one person spoiled it for the whole class’ thinking is lofted as a kind of justice.

    It isn’t.

    ‘Somebody might use it wrong.’ Somebody might hear these words/see this movie and go on a shooting rampage.’

    I reject this categorically as I am a free citizen in a free country. I want to be responsible for my actions, not the actions of the least of us.

    • #2
  3. Midget Faded Rattlesnake Contributor
    Midget Faded Rattlesnake
    @Midge

    GLDIII (View Comment):
    Snakes….Playing loose with the headline copy.

    Like I’m the only one!

    • #3
  4. Mike H Coolidge
    Mike H
    @MikeH

    Damn it! So what you’re telling me is I need to stock up? I always wondered why the damn things were so hard to open. It’s a PITA.

    Are you not going to be allowed to buy more than one pack at a time? I imagine the price is going to go up commensurately. If I recall they’re pretty cheap.

    • #4
  5. GLDIII Reagan
    GLDIII
    @GLDIII

    Midget Faded Rattlesnake (View Comment):

    GLDIII (View Comment):
    Snakes….Playing loose with the headline copy.

    Like I’m the only one!

    I know of no other snakes on Ricochet, you are the only one.

    Cats, dogs, airplanes? We got plenty of those.

    • #5
  6. Locke On Member
    Locke On
    @LockeOn

    Guess it’s time to lay a few away if that’s the way things are going…

    I’ve never noticed any side-effects when using the stuff for the Mexican cha-chas, but I seem to be fairly insensitive to opioids in general.

    • #6
  7. Mole-eye Inactive
    Mole-eye
    @Moleeye

    There’s always a silver lining:  I never before knew that loperamide was an opiate, but it makes sense, as opiates are notorious for causing constipation.

    After enforcing drug laws for 30+ years, I’ve just about come round to my husband’s libertarian viewpoint.  Legalize everything in unrestricted amounts and let the junkies kill themselves off.  Perhaps things would be better after the death-wave has passed.

    Meanwhile, another governmental bureaucracy follows in the footsteps of DHS/TSA.  “It the wrong thing to do, but at least we’re Doing Something.”

     

    • #7
  8. Mole-eye Inactive
    Mole-eye
    @Moleeye

    PS: terrific headline Midge!

    • #8
  9. TheRightNurse Member
    TheRightNurse
    @TheRightNurse

    I am so happy that you are staying on top of the FDA and the overregulation going on.

    Every drug can be abused.  Every drug.  You cannot stop kitchen chemists from developing new stupid uses for everything.  We haven’t banned whipped cream yet, despite the fact that people have been doing whip its for about 40 years.  People are still huffing hair spray.

    There is a point where we have to let people make bad choices.  They are only hurting themselves at this point.

    • #9
  10. MarciN Member
    MarciN
    @MarciN

    My mom took loperamide quite often. It does not (at least the pharmacists didn’t think it did years ago) interact badly with a lot of common drugs such as those taken for high blood pressure or tranquilizers.

    There have only been ten deaths in almost forty years from overdoses? I wonder what the circumstances were–if these patients were so distressed with diarrhea that they overdosed or were they trying to get heroin-like effects.

    Making it harder for people to buy Imodium D is not the right answer.

    It will make it much harder for caregivers like parents of three or four sick kids. The diarrhea bug tends to run through a household.

     

    • #10
  11. E. Kent Golding Member
    E. Kent Golding
    @EKentGolding

    I carry the stuff Backpacking.   Never had to use it,   but dysentery can kill — I want to be able to walk out of my backpacking trip without dehydration.

    • #11
  12. TheRightNurse Member
    TheRightNurse
    @TheRightNurse

    MarciN (View Comment):
    It will make it much harder for caregivers like parents of three or four sick kids. The diarrhea bug tends to run through a household.

    In a fun and weird aside, I just had that bug (and am now kinda recovering from it).  In my misery, I decided to study why the hell the body would actively lose fluids during an illness.  Turns out that it has to do with the particular type of bug and flushing it out though increasing cellular gaps and increasing the flow of fluid.  There’s some interesting rat studies where they’re mutating rats to make them incapable of the normal flushing process and comparing them with normal rats.

    As horrid as diarrhea is, it appears much, much worse without it.

    Something to think about.  Be grateful(?).

    • #12
  13. MarciN Member
    MarciN
    @MarciN

    TheRightNurse (View Comment):

    MarciN (View Comment):
    It will make it much harder for caregivers like parents of three or four sick kids. The diarrhea bug tends to run through a household.

    In a fun and weird aside, I just had that bug (and am now kinda recovering from it). In my misery, I decided to study why the hell the body would actively lose fluids during an illness. Turns out that it has to do with the particular type of bug and flushing it out though increasing cellular gaps and increasing the flow of fluid. There’s some interesting rat studies where they’re mutating rats to make them incapable of the normal flushing process and comparing them with normal rats.

    As horrid as diarrhea is, it appears much, much worse without it.

    Something to think about. Be grateful(?).

    That’s interesting. My mother-in-law  used to say that it was a good thing to get diarrhea because it meant the body was getting rid of the germs. She was right.

     

    • #13
  14. The Reticulator Member
    The Reticulator
    @TheReticulator

    MarciN (View Comment):

    TheRightNurse (View Comment):

    MarciN (View Comment):
    It will make it much harder for caregivers like parents of three or four sick kids. The diarrhea bug tends to run through a household.

    In a fun and weird aside, I just had that bug (and am now kinda recovering from it). In my misery, I decided to study why the hell the body would actively lose fluids during an illness. Turns out that it has to do with the particular type of bug and flushing it out though increasing cellular gaps and increasing the flow of fluid. There’s some interesting rat studies where they’re mutating rats to make them incapable of the normal flushing process and comparing them with normal rats.

    As horrid as diarrhea is, it appears much, much worse without it.

    Something to think about. Be grateful(?).

    That’s interesting. My old Italian mother-in-law (and don’t knock Italian mothers-in-law until you’ve had one! they are wonderful!) used to say that it was a good thing to get diarrhea because it meant the body was getting rid of the germs. :) :)

    So if I get to see her in the afterlife, I will tell her she was right and make her laugh. :) :) :)

    Maybe the cholera method would be taking it too far, though.

    • #14
  15. PhilB Inactive
    PhilB
    @PhilB

    What an exasperating fit of do-gooderism!

    My system is vulnerable to diarrhea. With readily available loperamide it’s never more than a nuisance. But I rely on keeping a supply on-hand.

    The risk across the US population approaches zero and yet we are going to sacrifice another freedom because it sounds righteous. There is a real health cost in inhibiting access to those who benefit from this amazing little meditation.

    • #15
  16. Mole-eye Inactive
    Mole-eye
    @Moleeye

    Like your comment, @PhilB.

    I have 3 words for you: Mexico.  Canada.  Smuggle.

    • #16
  17. Randy Weivoda Moderator
    Randy Weivoda
    @RandyWeivoda

    Not having read all of the links in the post, how many doses does it take to get high?  Quite a few I’d think.  I’m just wondering what happens to a person when they take enough Imodium D to get high from it.  I would think they would have such galactic-level constipation that they’d be killed trying to go to the bathroom.

    • #17
  18. Midget Faded Rattlesnake Contributor
    Midget Faded Rattlesnake
    @Midge

    Randy Weivoda (View Comment):
    Not having read all of the links in the post, how many doses does it take to get high? Quite a few I’d think. I’m just wondering what happens to a person when they take enough Imodium D to get high from it. I would think they would have such galactic-level constipation that they’d be killed trying to go to the bathroom.

    If you’re not taking it with a P-glycoprotein inhibitor, yeah… I certainly wouldn’t recommend trying it. But then, I wouldn’t recommend trying heroin, either.

    Addicts, though, are so acclimated to opioids in the system that withdrawal leaves ’em pretty trotty anyhow.

    One might cynically wonder if what’s got the FDA worried is the spread of knowledge that combining loperamide with a P-glycoprotein inhibitor gives it central opioid action at a lower dose, which might be used not just for a high, or dope withdrawal, but also for more prosaic things like pain control. But that’s cynical even for me. I think more likely, regulators simply feel they must Do Something. This is Something. Therefore they must Do It.

    • #18
  19. Stina Member
    Stina
    @CM

    TBA (View Comment):
    When this sort of thing is lofted I am transported back to primary school where ‘one person spoiled it for the whole class’ thinking is lofted as a kind of justice.

    I am under the impression that this kind of thing works when you are trying to get a group to behave as a team or a family unit. I would do this to my kids.

    But not all group scenarios should be meant to produce a cohesive team or family unit.

    It doesn’t work in large, disconnected groups, especially in communities where community is sorely lacking, like just about all of America at the moment.

    • #19
  20. Midget Faded Rattlesnake Contributor
    Midget Faded Rattlesnake
    @Midge

    MarciN (View Comment):
    There have only been ten deaths in almost forty years from overdoses?

    They say there has recently been an alarming increase since 2015, but ten in forty years as of 2015 is such a low baseline to start with that I’m not sure what counts as alarming. Two deaths since 2015? Five?… I suppose we’ll eventually find out once those statistics are gathered.

    • #20
  21. TBA Coolidge
    TBA
    @RobtGilsdorf

    TheRightNurse (View Comment):

    In a fun and weird aside, I just had that bug (and am now kinda recovering from it). In my misery, I decided to study why the hell the body would actively lose fluids during an illness. Turns out that it has to do with the particular type of bug and flushing it out though increasing cellular gaps and increasing the flow of fluid. There’s some interesting rat studies where they’re mutating rats to make them incapable of the normal flushing process and comparing them with normal rats.

    As horrid as diarrhea is, it appears much, much worse without it.

    Something to think about. Be grateful(?).

    I have always been grateful to not be a mutated rat.

    • #21
  22. DocJay Inactive
    DocJay
    @DocJay

    Good Lord.  Methadone is deadly.  Imodium is a joke.

    • #22
  23. OmegaPaladin Moderator
    OmegaPaladin
    @OmegaPaladin

    I refuse to be treated as an addict for wanting to be prepared in case of illness.  I am a blood and thunder drug warrior, but this is insane.  A two day supply?  Seriously, have these people never had a lower GI illness before?  I felt like I had the entire democratic congressional delegation rampaging in my colon, then I took loperamide and I was able to actually leave the bathroom.  I was not in an altered state of consciousness and I certainly was not in euphoria outside of simple relief.

    It’s like the restrictions on buying pseudephedrine (Sudafed) out of fears that people will use it to cook meth.  Because meth heads never engage in criminal activity to obtain chemicals for making their product.

    • #23
  24. The Reticulator Member
    The Reticulator
    @TheReticulator

    TBA (View Comment):
    I have always been grateful to not be a mutated rat.

    All rats are mutated rats.

    • #24
  25. TheRightNurse Member
    TheRightNurse
    @TheRightNurse

    OmegaPaladin (View Comment):
    Because meth heads never engage in criminal activity to obtain chemicals for making their product.

    Do you mean to say that criminals…break laws?!?

    How dare you presume!  Criminals are people too! #themtoo

    • #25
  26. TBA Coolidge
    TBA
    @RobtGilsdorf

    TheRightNurse (View Comment):

    OmegaPaladin (View Comment):
    Because meth heads never engage in criminal activity to obtain chemicals for making their product.

    Do you mean to say that criminals…break laws?!?

    How dare you presume! Criminals are people too! #themtoo

    Yeah. Dude, you really don’t want to upset the Criminal-American Community.

    • #26
  27. Jager Coolidge
    Jager
    @Jager

    Midget Faded Rattlesnake: “On the rise” from only ten deaths in a nearly forty-year period could mean many things. I wonder what counts as an alarming rise.

    Really, from 1999 to 2015 over 900 people were killed by lawn mowers and over 10,000 fell from bed. There are lots of things we need to regulate ;)

    http://www.businessinsider.com/weird-causes-of-death-2016-7/#w75-accidental-suffocation-and-strangulation-in-bed–10206-deaths-7

    If  “on the rise” were a real thing they would say there ten deaths in 38 years and 100 or 1000 deaths a year in the last few.

    • #27
  28. SkipSul Inactive
    SkipSul
    @skipsul

    Randy Weivoda (View Comment):
    Not having read all of the links in the post, how many doses does it take to get high? Quite a few I’d think. I’m just wondering what happens to a person when they take enough Imodium D to get high from it. I would think they would have such galactic-level constipation that they’d be killed trying to go to the bathroom.

    Back when Who Wants to be a Millionaire was big on TV, with Regis Philbin hosting it, he put out a silly and rambling collection of essays called Who Wants to be Me?  I read it (perks of working at a book store – we could borrow hardbacks like the store was a library).  Regis had a funny story about OD-ing on imodium.

    He took something like 4 of those pills over 12 hours because he was really sick.  The runs stopped sure enough, but so locked down his digestion that he ended up in the hospital anyway, and then had to be on laxatives to get things going again.

    • #28
  29. Susan Quinn Contributor
    Susan Quinn
    @SusanQuinn

    We always took it with us on our distant travels. When you need the stuff in a second or third-world country, you don’t want to go running around, looking for a drug store. And I assume that it goes out of date like any treatment, so every time we travel we buy it anew. This is a foolish, meaningless gesture on the part of the FDA.

    • #29
  30. Midget Faded Rattlesnake Contributor
    Midget Faded Rattlesnake
    @Midge

    Susan Quinn (View Comment):
    When you need the stuff in a second or third-world country, you don’t want to go running around…

    No you don’t, do you?!

    • #30
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