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US Officials Seek Packaging Fix To Curb Abuse Of Anti-Diarrhea Drug

Loperamide sold as Imodium slows down the movement of the gut to make stool less watery using an opioid which induces a high akin to Oxy Contin

Loperamide, sold as Imodium, slows down the movement of the gut to make stool less watery using an opioid, which induces a high akin to OxyContin.

The medication is safe to take at approved doses but can lead to severe heart rhythm problems and death if taken at much higher doses than recommended.

"That's why we have to respond to it and make sure that we make it as hard as possible for people to abuse this over the counter medicine", she said, adding that Imodium is totally safe is taken as directed and at this point, there's no effort out there to make people show an ID to get the drug over the counter or for it to require a prescription.

They are also part of the agency's efforts to reduce patients' exposure to opioids, which killed more than 42,000 Americans in 2016, according to estimates from the Centers for Disease Control and Prevention.

As a result, the FDA this week asked manufacturers of the anti-diarrhea treatment to voluntarily lessen the amounts of medication per package, making it tougher to abuse. Evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death. One example is a single retail package containing eight 2-milligram capsules in blister packaging.

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The FDA already slapped a warning on OTC loperamide labeling in the spring of 2017, cautioning users about the dangers of misuse. "If you're selling a drug with the potential for abuse and misuse through an online website, you're no longer in the business of selling widgets or books", he said.

"Abuse of loperamide has been increasing in the United States", Dr. Gottlieb said. "Even if you limit the quantities available in any individual package, if you can buy a lot of packages on line, that doesn't fix the issue that the drug is easily accessible", he said. The FDA, however, is asking online suppliers to take voluntary steps to address the problem.

They published a paper in the Annals of Emergency Medicine in 2015 that described two loperamide deaths. Similar restrictions have been placed on over-the-counter medications containing pseudoephedrine, which can be used to make methamphetamine. Found unresponsive at home, along with six empty boxes of loperamide, he appeared to have had a seizure.

In the second case, a 39-year-old with a history of opioid addiction was reported to have suddenly gasped for breath and collapsed at home.

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