Drug War Update: Aspirin an ally, Imodium Not So Much

by Andrew Stuttaford

Drug warrior Jeff Sessions has come up with a suggestion to help combat opioid abuse:

“I am operating on the assumption that this country prescribes too many opioids,” Sessions said Wednesday as he touted the Trump administration’s efforts to combat drug abuse and trafficking. “People need to take some aspirin sometimes and tough it out a little.”

Okey dokey.

Meanwhile, CBS reported a few days ago on the possible opening of a  possible new front in the drug wars:

As part of its efforts to combat the opioid epidemic, the U.S. Food & Drug Administration is asking manufacturers of over-the-counter anti-diarrhea treatments to change the way they package their products. The FDA says the voluntary measures are needed to curb the growing abuse of loperamide – sold under the brand name Imodium A-D, as well as store brands and generics – which is used by some suffering from opioid addiction as a potential way to manage withdrawal or maintain a high.

“Voluntary measures are needed…”

Loperamide is safe at approved doses, up to a maximum of four 2-milligram tablets per day without a prescription. “But when higher than recommended doses are taken we’ve received reports of serious heart problems and deaths with loperamide, particularly among people who are intentionally misusing or abusing high doses,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.

“We’ve received reports”

Experts say it takes an enormous dose of anti-diarrhea medication to get high. Addicts have been found to be popping anywhere from 50 to 300 pills per day.

According to a 2016 study published in the Annals of Emergency Medicine, Imodium A-D, in massive doses, works in the body the same way as heroin, morphine, and oxycodone. However, Imodium A-D is a cheaper alternative since some big box stores sell 400 tablets for less than $10.

“Folks that are desperately addicted, folks that are looking to stave off withdrawal symptoms will do whatever it takes sometimes, really extreme things,” Dr. Jeffrey Reynolds, of the Family and Children’s Association, told CBS New York at the time that study was published. “So in the scheme of things, taking 300 pills is not unheard of.”

“Not unheard of”

Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City, says he has encountered patients who abuse loperamide either to get high or to self-treat symptoms of opioid withdrawal.

“Has encountered patients”

[Last] week, the FDA sent letters to manufacturers asking that they take additional steps, including limiting the amount of loperamide per package for short-term use. For example, a retail package could contain eight 2-milligram capsules – enough for two days.

“Asking”

The end-game is probably to subject Imodium to the same  nannying regime as Sudafed and its equivalents, now exiled behind the pharmacy counter and only available on production of i/d and in limited quantities – all in the name  of the war against meth.

As I’ve tried to emphasize, the FDA’s comments on the loperamide, uh, crisis seem a little vague.

Reason’s Mike Riggs has been on the case:

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.

Drug war theater, or just more evidence that the drug warriors have lost their minds?

Take your pick.

The Corner

The one and only.