FDA Urges Makers of Diarrhea Drug to Help Stop Abuse
Numerous reports show an increase of opioid users abusing loperamide, an over-the-counter medicine used to treat diarrhea. The FDA is taking steps to stop this disturbing trend.
By Linda Thrasybule
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February 13, 2019
The Food and Drug Administration (FDA) recently asked makers of anti-diarrheal medication to change the way its product is sold, to curb abuse by people who are addicted to opioids.
The request is an attempt to crackdown on the increasing number of people who take dangerously high doses of loperamide — sold under the brand name Imodium A-D as well as store brands and generics — to get “high” or manage symptoms of opioid withdrawal.
Loperamide is known as the “poor man’s methadone,” and opioid addicts ingest from 50 to 300 pills to feel euphoric or deal with opioid withdrawal symptoms, such as cramps, diarrhea, vomiting, and nausea.
The recommended daily dose of Imodium is 8 milligrams (mg) for over-the-counter use, and 16 mg for prescription use.
"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," Scott Gottlieb, MD, FDA commissioner, said in a statement.
The FDA is asking manufacturers to limit the amount of loperamide per package so that a single package will now contain 8 2-mg capsules in blister packaging. This, they say, will make it hard — and costly — for opioid addicts to buy the product in massive quantities. They’re also urging online retailers to stop selling the drug in large volume containers, which are often purchased in bulk.
“Evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death,” Dr. Gottlieb said in a press release.
The country is currently facing its worst public health crisis in history. The Substance Abuse and Mental Health Services Administration reported that in 2019 alone, 12 years or older misused opioids — prescription pain relievers and heroin.
Deaths from prescription opioids, like oxycodone, hydrocodone, methadone, and morphine, have more than quadrupled since 1999, reports the Centers for Disease Control and Prevention (CDC).
From 2010 to 2015, the number of abuse calls related to loperamide alone nearly doubled, according to a study published in January 2019 in theAnnals of Emergency Medicine.
“It’s important that we try to stem all avenues and conduits that contribute to opiate abuse and misuse,” says Robert Glatter, MD, spokesperson for American College of Emergency Physicians and assistant professor of Emergency Medicine at Northwell Health in New York City.
Loperamide was approved in 1976 as a prescription drug and a controlled substance, due to its small amount of opiates. But because it metabolizes quickly in the gut and doesn’t affect the central nervous system, the drug was considered safe and reached over-the-counter status in 1988.
The medicine works by slowing down the movement of the gut. This decreases the number of bowel movements and makes stool less watery.
“For most people, it’s relatively safe when taken at the recommended dose,” says Jeffrey Baumgardner, MD, a gastroenterologist and assistant professor of medicine in gastroenterology at the University of California in San Francisco.
While loperamide may help to reduce diarrhea-related withdrawal, it may have the opposite effect at higher doses, warns Dr. Glatter. People can be at risk for developing digestive issues, including abdominal distention, nausea, vomiting, and bloating.
“The irony is that loperamide is only a weak opioid, and not an effective way to reduce withdrawal symptoms,” says Glatter. “Yet, the fact that it has some opioid effects leads many to attempt to use it for relief because it’s cheap and readily available.”
Since loperamide works the same as an opioid, it can also suppress the body’s urge to breathe, causing irregular heartbeats, which can lead to cardiac arrest, or even death.
In a statement, Johnson & Johnson, a manufacturer of anti-diarrheal medication, said they were “evaluating the agency’s request and share their goal to prevent misuse and abuse.”
But whether companies will honor the agency’s request remains to be seen.
While blister packaging may help reduce abuse to some degree, Glatter says public messaging and education to raise awareness of loperamide abuse is just as important.
“Parents of teens should also be aware of this surreptitious approach to misuse and abuse,” he says.
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