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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