Federal regulators approve new rules requiring smaller packages of Imodium. They hope this will prevent people addicted to opioids from misusing the drug.
The opioid epidemic is driving some users to abuse common, over-the-counter medications. Now, federal regulators are stepping in.
Loperamide, sold as a generic drug and under the brand name Imodium, is used to treat different varieties of diarrhea. It’s considered safe, with low potential for abuse.
It’s also an opioid — the only one available without a prescription.
Since 2015, the U.S. Food and Drug Administration (FDA) and researchers have noticed an increasing trend for opioid users to take large quantities of loperamide off-label to help with withdrawal symptoms.
That’s earned the product the nickname “the poor man’s methadone.”
In response to a growing body of evidence of loperamide misuse, the
The FDA is requesting that manufacturers of loperamide abide by new packaging regulations. These regulations would lower the total amount of the drug in a single package, making it more appropriate for short-term rather than long-term use.
The regulators are also urging online retailers who sell loperamide to stop bulk sales of the drug and end sales of “large volume” containers of pills.
“I believe anyone who is distributing healthcare products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse… You have a social contract to take voluntary steps to help address public health challenges,” said FDA Commissioner Dr. Scott Gottlieb in a press statement.
William Eggleston, PharmD, a clinical toxicologist and professor at Binghamton University in New York, calls the FDA’s move “a good first step” but warns that online retailers, including Amazon, are still flooding the market with the drug.
“This results in a cheap, legal, and easily accessible opioid medication that also causes deadly cardiac toxicity when abused… We will need to keep a close eye on the impact of the FDA’s recommendations and reassess the issue if a meaningful reduction in abuse does not occur,” Eggleston told Healthline.
Users trying to get high off of loperamide have to use large quantities of the drug — far beyond recommended daily doses.
According to reports, some loperamide users ingest 70 to 100 milligrams (mg) of the drug per day. The maximum recommended dose for loperamide is 16 mg per day.
Some cases are even more extreme. In 2015, BMJ Case Reports documented a 26-year-old man who was taking 800 mg of the drug per day.
Between 2011 and 2015, Eggleston and his colleagues saw a seven-fold increase in calls about loperamide at their poison center in upstate New York. The data is similar to national statistics that showed a 71 percent increase in intentional misuse of the drug between 2011 and 2014.
Unlike opioids used for pain relief, loperamide has
Loperamide is such a safe and effective drug, it’s included on the
However, high doses can make loperamide dangerous, even deadly.
The most dangerous effect of loperamide abuse is heart dysrhythmia and heart attack.
In 2016, Eggleston co-authored a study examining the deaths of two individuals who were both heavy loperamide users.
“Postmortem toxicology suggest that loperamide likely precipitated both deaths,” they wrote.
Eggleston believes there have been many more loperamide-related deaths since then.
Federal officials have previously taken steps to limit availability of certain over-the-counter medications.
Several states have passed legislation banning the sale of dextromethorphan, a common ingredient in cough medicine, to minors.
In 2006, the government enacted the Combat Methamphetamine Epidemic Act, which forced retailers to limit sales of pseudoephedrine, a popular drug used in cold medicines as a nasal decongestant, because of its use as a meth precursor chemical.
Eggleston has suggested that if loperamide abuse can’t be curbed through the FDA’s proposed measures that it should be moved behind the counter.
Loperamide abuse is dangerous, but it’s also indicative of the perils faced by those who are addicted to opioids and can’t find the means to get clean.
“The fact that individuals with opioid use disorder are turning to loperamide as an opioid substitute is consistent with the reality faced by many patients with opioid use disorder, said Eggleston.
“At the moment we do not have adequate resources to treat the large number of patients suffering from the harms of opioids. The message is the same: we need more healthcare providers, more funding, and more resources. We also need to use those limited resources in the most effective way possible,” he said.