Runs On Imodium Before The FDA Clamps Down

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How can you not hate the term "Nanny State?" It's *so* overused and trite. Even the people who want one probably prefer to call it something else. But, in this case, I can't come up with a better alternative. Except for maybe "Fannie State," since, as you will see, you have just lost a little control over what comes out of yours and at what rate it does so.  

What is going on is vaguely reminiscent of 2006 when Sudafed came off the counters so that it could not be used to cook meth (1). So now you have to show ID and get listed in a DEA database, all to get Sudafed for a runny nose. There is a limit of how much you can buy per month. Or you can try the monumentally useless, but non-abusable substitute Sudafed PE.  

New stinky Sudafed PE can be bought over the counter, but it's just about useless. Old Sudafed, which works well is now a bit more difficult to obtain.

The mindset behind this latest move (movement?) is much of the same: If there is a drug that can possibly be abused then it is absolutely essential to make it as difficult as possible for the 99.9% of the population who don't abuse it to get their hands on it.

This time its the anti-diarrheal medicine Imodium (generic name loperamide). The drug will still be sold over the counter, but it will come in limited quantities in those hideous blister packs that Houdini couldn't open.

Does anyone see the humor/irony here? A diarrhea medicine package that's hard to open?

Blister pack Imodium. Not so great when you actually need it.

It's not as if the FDA warning makes no sense. After all, some people are being harmed.

"We continue to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide..."

But who is being harmed?

"...primarily among people who are intentionally misusing or abusing the product..."

Ah, so here we go again. Those of us who don't abuse drugs have to jump through hoops so that people who do abuse (2) them won't be able to. More Ninny-Nanny State.

So, this stuff must be a bubonic plague-like killer, right? Not so much:

"In the 39 years from when loperamide was first approved in 1976 through 2015, FDA received reports of 48 cases of serious heart problems associated with use of loperamide...Thirty-one of these cases resulted in hospitalizations, and 10 patients died."

Source: FDA

THIS is what all the hysteria is about? This comes to 1.23 cases per year of serious heart problems and 0.25 deaths associated with the use of loperamide. This means there is 1 death annually per 1.1 billion people in the US. One death every 4 years. Here are some comparable death risks.

  • Death from being hit by a falling coconut (1 in 250 million)
  • Death from a shark attack (1 in 300 million)
  • Death from a roller coaster accident (1 in 300 million)

Since every non-problem has a non-solution it should not be surprising that some want the drug behind the counter - an increasingly crowded place.

 “Even if you limit the quantities available in any individual package if you can buy a lot of packages online, that doesn't fix the issue that the drug is easily accessible...[I]f loperamide abuse continues to be a problem, authorities should consider moving the drug behind the counter, which would require consumers to ask their pharmacists for it."

William Eggleston,  Binghamton University's School of Pharmacy and Pharmaceutical Sciences. Remember when you had to ask for condoms behind the counter? Thoroughly embarrassing. Or so I'm told.

And to get yourself into trouble you need to take a whole lot of it. The recommended dose is 2-4 mg per day (maximum is 16 mg/day). This woman didn't pay attention:

A 48-year-old woman with a history of alcohol and benzodiazepine abuse presented to the emergency department (ED) with somnolence, weakness and slurred speech. She was taking 20 to 40 tablets of 2mg loperamide 1-2 times/day for weeks along with clonazepam and whiskey.

But survived:

Over the next 48 h she improved and was transferred to a floor bed. On day four of hospitalization the patient left against medical advice."

So, in a country where 480,000 people die every year from smoking, and another 130,000 from accidents and 40,000 more from suicides we will be facing another indignity (and possible underwear incidents) just because some people are abusing a 70-year old medicine which is 4.6 times less dangerous than a coconut. This country has gone completely coconuts about opioid drugs.

NOTES:

(1) Which resulted in better ways to make it. See: Phenyl-2-propanone (P2P)

(2) An obvious reason that this is coming up now is the "Opiate Crusade." Some people use loperamide to try to get themselves off opioids. It is sometimes called a "poor man's methadone." It doesn't work very well.