Opioids

Addicts Use Imodium to Help With Detox. That's a Terrible Reason for the FDA to Make It Harder to Get.

The opioid crisis is starting to drive people crazy.

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The FDA doesn't trust you to treat your own runs.

Over-the-counter medicine frees Americans to treat minor health issues without first consulting an expert. For no ailment is this freedom more of a godsend than a pesky case of the runs. You can grab a box of Imodium A-D (or the store brand of the active ingredient, loperamide), walk to the checkout counter, and pay, all without breathing a word about your messy butt to anyone.

But now the opioid crisis has driven regulators into absurd fits of caution. The Food and Drug Administration (FDA) wants to make loperamide less accessible because opioid addicts might abuse it. And some in the health industry argue that you should have to ask a pharmacist and present a government-issued ID to buy the drug, as is currently the case with pseudoephedrine.

In a statement published Tuesday, the FDA announced that it "continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product." In response to these reports, the agency wants loperamide manufacturers to limit the number of doses per package to a few days' worth and to make the pills available only in blister packs rather than bottles.

Loperamide is a very, very mild opioid, and like all opioids, it slows down the muscles that send poop through your pipes. But unlike most other opioids, it's doesn't affect other parts of the body unless you take a shit-ton. The maximum therapeutic dose is 16 milligrams in the course of a day; people using it either to get high or to chase away withdrawal symptoms will take more than 100 mg. Doses that high can (but don't often) cause "adverse cardiac events."

That's just a mild inconvenience, you might object, if the changes will protect people's hearts. But this week's FDA notice does not say how many people have died or been seriously injured from loperamide overdoses, how many adverse events might be avoided by changing to blister packs, or how much retooling loperamide production facilities will cost manufacturers (and ultimately consumers). These are not small asks. The answer to the first question tells us whether the second two are even worth considering; the second question helps us understand whether the imposition implied by the third is reasonable.

Since the FDA isn't being forthcoming, how might we determine how many people are abusing loperamide? A good start would be to look at toxicology and mortality data. Here's the research I found on loperamide abuse published in the last two years:

  • According to a 2016 study of loperamide-related deaths in North Carolina, published in the Journal of Analytical Toxicology, the North Carolina Office of the Chief Medical Examiner found above-therapeutic levels of loperamide in 21 deceased persons between 2012 and 2016; the drug is said to have played some role in 19 of those cases. In only one case—that of a 21-year-old male who had a history of overdoses—was loperamide the only drug present.
  • A review of New York Poison Control data published by the Centers for Disease Control and Health and Human Services uncovers 22 cases of intentional loperamide abuse between 2008 and 2016; 15 of the patients had a history of opioid abuse. The average daily dose was 358 mg, and the full range was 34 mg (twice the daily recommended maximum) to 1,200 mg (75 times the maximum). The report does not disclose any fatal overdoses. The same study looked at the National Poison Database System and found 179 cases of intentional loperamide abuse from 2008 to 2016. The average loperamide dose across those cases was 196 mg, ranging from 2 mg to 1,200 mg. The paper includes clinical outcomes for 132 of those cases: 66 patients suffered "life-threatening symptoms or residual disability"; four of them died.
  • A 2017 review published in the Journal of Emergency Medicine found a much larger number of loperamide misuse/abuse cases between 2009 and 2015. The researchers found 1,925 poison control reports of loperamide being mixed with another drug and 947 reports of loperamide taken in isolation. Of all those, 381 were classified as intentional drug abuse and 15 were classified as attempts to manage opioid withdrawal symptoms. Across five years, only four cases of loperamide used in isolation and 19 cases of loperamide used with another drug resulted in death.

Let's assume that the last report is the most comprehensive. So from 2009 and 2015, 2,872 Americans over the age of 12 intentionally misused or abused loperamide—for reasons ranging from attempted suicide to opioid withdrawal—by taking a dosage of at least twice the daily recommended amount, and 17 people died as a result.

Or, we can use the North Carolina number of 21 deaths in which loperamide may have played a role, multiply that number by 50, and divide by the number of years (four) the study covered. That would give us an annual loperamide death toll of 262.5. I think that number is laughably wrong, but if we're going to say that it demands a policy response of either changing the packaging of antidiarrheal drugs or making them available only at the discretion of a pharmacist, then we should probably also do something about Tylenol and other products containing acetaminophen: America's most common pain reliever kills somewhere between 150 and 500 people each year, and annually sends 55,000 to 80,000 people to emergency rooms across the country.

What's that? You don't want to pay $10 for a 10-count of blister-packaged Tylenol? Well, you must not care about the acetominophen crisis.

This is not to say that intentional loperamide misuse/abuse is not a trend. Due to the unavailability of drugs that treat opioid withdrawal, coupled with the reduced availability of prescription opioids, it's almost certainly true that opioid addicts have turned to over-the-counter diarrhea medicine either to get high or to avoid the physical and psychological pain of withdrawal. But the data we have says there is no loperamide crisis, and the sheer amount of loperamide necessary to mimic the effects of even a small amount of heroin suggests that even if we do nothing, there likely never will be.

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  1. all without breathing a word about your messy butt to anyone

    For those confessions, there’s the Hit’n’Run comments.

    1. Another good way to hear about it is to give Citizen X your cell number.

      1. It’ll be a cold day in hell before i talk to any of you people for any reason.

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  2. But the data we have says there is no loperamide crisis, and the sheer amount of loperamide necessary to mimic the effects of even a small amount of heroin suggests that even if we do nothing, there likely never will be.

    So the loperamide crisis is, you would say, a load of crap?

    1. These politicians are definitely full of shit.

      1. These bureaucrats are definitely full of…

    2. It’s right behind the heroin crisis, sitting firmly as number two.

    3. The only person at H&R who is truly qualified to comment on this topic is Palin’s Buttplug.

    4. Make that liquid crap

  3. One can overdose on water, see http://www.webmd.com/fitness-e…..xication#1 …

    Water should be by prescription only! Bonus is: It would make prescribing physicians richer, and stimulate the economy!

    1. When presented this way, you can get many people to argue for a total ban on it.

      1. Yep, I’ve pulled that prank more than once myself. It never really gets old for me.

      2. When presented this way, you can get many people to argue for a total ban on it.

        Years ago, Neal Boortz alerted Atlanta to the presence of DHMO in the municipal water supply even prompting a spokesperson to explain, “that there was no more dihydrogen monoxide in the system than what was allowed under the law”.

        About half-way down the story…

  4. This is a pile of shit.

    Ask anyone whose GI tract tends to run ” a bit fast”. Just like psuedofed, it will NOT be “just a little inconvenience” to have to wait in line and then present an ID to get this stuff. The dimwits proposing this legislation never consider how many hours are wasted (as a population) trying to get relief from a drippy nose, ragweed or mold, and they have no conception of what it can do to a libertarian’s blood pressure. And don’t even start me on having to “agree” to a bunch of conditions on a damned computer screen … at least they could do a good edit on the frickin’ language so that one “acknowledges”.

    B.S.

    1. If even one person is helped, then any amount of inconvenience is worth it.

      1. No.

    2. We need more woodchippers involved in political discourse.

  5. This behind the counter BS is getting really irritating.

    I will never buy the stuff they keep behind the counter and if a medicine requires a date of birth or some stupid shit, I “accidently” dump a whole bunch of the packages on the floor for employees to clean up.

    This alarmed packages are especially fun to set off in the store and act like you have no idea why it happened.

    Drug warriors suck.

    1. Your local pharmacy is staffed entirely by former congressmen who voted in favor of the CMEA amendment to the PATRIOT Act? Because if that’s not the case, you’re just being a dick to some register biscuits.

    2. Do you also knock over all the alcohol for requiring a date of birth?

      Also, come on man. Don’t fuck with clerks, they don’t need that shit.

      1. Imodium is not alcohol.

    3. Rather than being a dick to people who don’t deserve it, I just make my wife buy it.

      1. Why does your wife deserve you being a dick to her?

        1. She once brought home a six-pack of beer that didn’t taste awful. He nearly divorced her on the spot.

  6. Keep your laws off of my poop

  7. Wait’ll they find out a lack of Imodium leads to a surplus of jenkum.

    1. Ain’t no such thing as Leftover Crack, and there ain’t no such thing as a surplus of jenkum.

      1. Jenkum? Holy shitty Shiites, I had never heard of that! Learn something new every day I guess…

        THAT is some seriously fucked-up shit!!! http://www.urbandictionary.com…..erm=jenkum

  8. What’s that? You don’t want to pay $10 for a 10-count of blister-packaged Tylenol? Well, you must not care about the acetominophen crisis.

    I don’t. Being on blood thinners and thus unable to use aspirin, I’d consider cutting off my access to Acetominophen to be the real crisis. Most, if not all people will eventually die from something.

  9. Bets on Ibuprofen being the next thing you have to show an ID for?

  10. But what about a junkie going through withdrawals who also happens to have the shits?

    1. Well, he’s a double victim and doubly valuable to politicians. We obviously need a new department to handle this situation. The DOSV sounds like a good departmental acronym to me.

    2. “Happens to have the shits?”

      You say that like they are unrelated.

      A lot of people in serious opiate withdrawal get the shits, along with the cramps, and the sweats, and the ‘holy crap it feels like God is trying to fold me into origami.’

      Articles like this are annoying because they are just dancing with the alligator. What do the details matter? You are going to lose.

      It is inevitable that government will create problems when it insists on restricting what substances people can consume.

  11. I remember reading about this, maybe 10-15 years ago, and wondering when they’d try to ban it. Que sera, sera!

    On a more positive note, this is a real boon for both doctors (like me) and the economy! Now you can just go to the nearest doc-in-a-box and ask for a script for Diphenoxylate or even better, Difenoxin – though, neither will get you high and both are laced with atropine to poison you and teach you a lesson about disobeying doctor’s orders and taking too much! It’ll be great: pay $200 bucks to be abruptly refused because you’re a foul-smelling “drug-seeker,” and be left to marinate in your diarrhea-filled pants while your doc thanks you for the nice Filet Mignon and lobster you just bought him for lunch. THAT’S how you improve doctor-patient relations. I wish I was as smart as the government!*

    *Besides, you filthy, degenerate junky, you deserve it!

    P.S., I’ve not bought Sudafed in many years. Ever since they began requiring a DNA sample while quadrupling the price and slashing the quantity, and otherwise inconveniencing me because of a few redneck meth cooks. “Hit ’em where it hurts” says I! (I’ll never be as concise and witty as some of you… 🙁 )

    1. Yep, they took good paying redneck jobs and shipped them to Mexico…no wonder trump was elected

  12. Aren’t blister packs terrible for the environment?

    1. I feed them directly to baby seals to avoid pollution

  13. Loperamide, DXM and Propylhexedrine kind of amaze me that they are still around, legal meth, opioid and dissociative (think PCP or Ketamine) that actually work and are widely sold, surprised the they have not been flat out banned yet.

  14. The removal of Imodium from grocery shelves, and an increase in its price, will inconvenience many people who rely on the OTC medicine to for various reasons. I’m an endurance runnss and I know many runners whose systems rebel against running. No matter what they do to control their intestines before and during a run, they need Imodium to get through long runs and races without having to stop twenty times to, um, use the bathroom (where often a bathroom is no where to be found). Nothing else helps, most of the time. But also people who suffer from IBS or nervous stomachs rely on Imodium – what if all these people need Imodium more often than the government deems necessary? They will be inconvenienced beyond having to stand in line at the pharmacy to get the drug.

    1. – what if all these people need Imodium more often than the government deems necessary? They will be inconvenienced beyond having to stand in line at the pharmacy to get the drug.

      Only inconvenienced in the beginning. After an ambitious federal agent notices their “Imodium-seeking behavior”, they will be put on a no-buy list. Then a doctor’s prescription will be required to buy it. But, they will have to find a doctor willing to risk long-term prison sentence for running a “Intestinal Medication Mill”.

  15. This is beyond ignorant. These sadomoralists never learn. Anyone taking the risk of taking enough pills to cause heart damage to get high (acute doses of 250-800 pills, 2mg per pill) or 400-1200 pills per day for months, is going to then do something even stupider trying to get high. Meanwhile the consequences for addicts facing withdrawal will be terrible (withdrawal from even a substantial habit is completely stopped by 100mg (50 pills) or less, q24-36h, way below any dosage that’s been implicated in arrhythmias, but much more than normal use) . They’ll be back losing jobs, going broke, losing homes, and committing crimes to get more of their normal opiate, instead of being able to live a normal, stable life that comes with never having to face withdrawal if you can’t afford the good stuff.
    Anyone recommending limiting access to loperamide is stupid, evil, or both.

  16. If I have to wait in line for Imodium for my IBS, I’m just going to have to drop trou and take a watery shit right there in the pharmacy. Worst. Libertarian Moment. Ever.

  17. It’s not just “minor health issues” of people with a little diarrhea here and there. An 8 pill supply would have people with ostomies and jpouches constantly at the pharmacy. They don’t have the organ that thicken things up. And many more don’t have that organ that functions right.

    The War On Drugs has turned into a War On The Sick. It’s time to end it all and try decriminalization of all drugs like Portugal. The War On Drugs is a massive failure and it just keeps getting worse as they decide on new targets to murder or harass. Portugal’s decriminalization and treatment is an instant success.

    Don’t think you’ll be able to avoid being one of the new targets. You’re one bad gene, accident or medical procedure away from being denied adequate care to save someone who’s getting illegal fentanyl from China.

    1. But if politicians can’t sell their influence, what will their market be? Maybe legalizing drugs will incentivize hot young types to run for office. I could live with that.

  18. I recommend we have a Immodium lobbying day so we can take a nice healthy dump in our Congressman’s office.

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