FDA takes action after opioid addicts getting high off anti-diarrhea medicine

Who knew that people addicted to opioids have found a way to get high off of anti-diarrhea medication?

I sure didn’t.

U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb has asked makers of loperamide, sold over the counter at Imodium AD, to change the way they package the product.

I did know that opioid use causes constipation. Have you seen the commercial with the good-looking middle-aged man at the construction site, happy his pain is gone but all bound up? Making jokes about it?

“Do you have OIC? Opioid? Induced? Constipation?”

The commercial has not set well with me for a long time. Now it sets even less well with me.

As an April 2017 article in The Atlantic put it, “If a drug that gets you high causes constipation, could a drug that causes constipation get you high?

Turns out, the answer is yes.

Doctors quoted in this CBS News story explain the phenomenon:

“It’s an opioid agent and it helps to bind receptors in the brain and cause a similar euphoria or high,” said Dr. Scott Krakower, a physician who specializes in addiction disorders at Northwell Health.

“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, said. “So, in the scheme of things, taking 300 pills is not unheard of.”

This is what has led to Gottlieb’s latest directives, which is a noble effort even if it’s like throwing a bucket of water on a burning house.

“The FDA is requesting that sponsors of OTC loperamide ‒ an FDA-approved product to help control short-term symptoms of diarrhea, including Travelers’ Diarrhea – change the way they label and package these drugs to stem abuse and misuse that leaves us deeply concerned,” Gottlieb announced Tuesday in a statement to the news media. 

“Abuse of loperamide has been increasing in the United States. When used at extremely high and dangerous doses, it’s seen by those suffering from opioid addiction as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use. The maximum approved daily dose for adults is 8 milligrams per day for OTC use and 16 milligrams per day for prescription use. It’s sold under the OTC brand name Imodium A-D, as store brands, and as generics.

“Loperamide is safe at these approved doses. 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. The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide.” 

These measures only work if people want to stop anyway

The FDA is asking – not requiring – loperamide manufacturers and online retailers to do the following:

We’re requesting that packages contain a limited amount of loperamide appropriate for use for short-term diarrhea according to the product label. One example is a single retail package containing eight 2-milligram capsules in blister packaging. We asked the manufacturers to take the necessary steps to implement these changes in a timely fashion to address these public health concerns.

I also plan to reach out to those who distribute loperamide online, through retail web sites, to ask them to take voluntary steps to help us address this abuse issue. The new packaging should help make limits on sales more easily achieved. The abuse of loperamide requires the purchase of extremely large quantities. Often this is done through the purchase of large bottles of loperamide, which is a common configuration in which the pill form of the medication is currently packaged. Today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.

In The Atlantic story written less than a year ago, the author reported, “Diarrhea-drug misuse is just a small, almost absurd part of the larger opioid epidemic.”

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And astutely pointed out that even more restrictive policies – requiring a photo ID to buy loperamide, for example – only works when people are discouraged by such measures to the point of seeking treatment.

“It only works if the restrictions drive people to treatment rather than to heroin,” The Atlantic reported.

Which sadly seems very unlikely. Similar measures on ephedrine have not seemed to stop the crystal meth epidemic.

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