FDA Acts To Curb Anti-Diarrhea Medication Abuse Without Cutting Off Access

By Kelly Burch 05/18/18

The FDA recently detailed their intention to address the issue of loperamide misuse without hurting patients who depend on the medicine.

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The opioid epidemic is said to have started in the medicine cabinet, and an over-the-counter drug common in many homes is the latest medication reportedly being abused by people who use opioids.

According to the Food and Drug Administration, the diarrhea medication loperamide, sold under the brand name Imodium AD, is being used to get an opioid-like high or to avoid the symptoms of opioid withdrawal. 

The drug acts on opioid receptors in much the same way that opioid pain medications do. Taken as directed it stays within the gut. However, at higher doses it can act on the brain.

“But when loperamide is abused and taken at extremely high doses, some of it can cross the gut lining, giving users an opioid like ‘high,’” FDA head Scott Gottlieb, MD, recently explained in a blog post. “We’re aware that those suffering from opioid addiction see loperamide as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects.”

Although the medication is safe when taken as directed, it becomes problematic when it is taken at a higher dose. Gottlieb said that some people are taking up to 100 times the recommended dose in order to achieve the desired effects. 

“But at these very high doses, it’s also dangerous. We’ve received reports of serious heart problems and deaths, particularly among people who intentionally misuse or abuse high doses,” he wrote. 

Gottlieb said that the FDA first became aware of this pattern of abuse in 2016 and is now working to deter the abuse of loperamide. In addition to labeling the drug with warnings about the dangers of high doses, the FDA is urging manufacturers to change the way that the drug is packaged and sold. 

“We’ve reached out to online sellers of these products to inform them of the public health risks and ask for their attention to the issue and their commitment to stop selling large quantities of the product,” Gottlieb wrote. 

The FDA has suggested that loperamide be sold in blister packs, making it harder to take pills in large doses. The drug is currently sold in multipacks that contain as many as 1,000 pills, a three-year supply of the recommended dose.

The FDA is asking manufacturers and retailers to stop selling these large packages. Large retailers including Walmart, Amazon and eBay have agreed to comply. 

Gottlieb said that these measures should cut down on abuse without affecting people with conditions like Crohn’s disease who need to take loperamide regularly. 

“We’re very mindful of balancing benefit and risk and the needs of patients in our mission to promote and protect public health,” he wrote. “The FDA’s actions to address drug misuse and abuse must be informed by an understanding of the complex social environment in which changing patterns of drug consumption occur. The agency is committed to addressing emerging issues of abuse and misuse while taking steps to safeguard the needs of patients who depend on these medicines.” 

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.

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