Ask Dr. Nandi: FDA moves to curb abuse of common diarrhea drug

US officials seek packaging fix for diarrhea-drug abuse

With 11.5 million Americans misusing prescription opioids in the past year and more than 40 people dying every day from overdoses involving prescription opioids, it has become abundantly clear that more vigilant action is needed from the FDA and others to get ahead of this crisis.

The Food and Drug Administration said Tuesday it is asking manufacturers to package their medications in smaller quantities, such as eight tablets per package. It's sold under the OTC brand name Imodium A-D, as store brands, and as generics. 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.

FDA Commissioner Scott Gottlieb addressed the ongoing opioid issue in a January 30 statement outlining steps to help prevent new addiction, curb abuse and overdoses related to opioid products.

US health regulators want makers of popular anti-diarrhea drugs to sell their tablets in smaller amounts to make them harder to abuse. The agency also wants makers to use "unit dose packaging", such as blister packs that must be individually unpeeled per dosage.

The FDA already slapped a warning on OTC loperamide labeling in the spring of 2017, cautioning users about the dangers of misuse. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects.

The agency also plans to encourage online retailers of the drug to take voluntary steps to address the issue.

Eggleston co-authored a 2016 report published online in the Annals of Emergency that described two men who died after ingesting large amounts of loperamide.

If loperamide abuse continues to be a problem, Eggleston said, authorities should consider moving the drug behind the counter, which would require consumers to ask their pharmacists for it. Similar restrictions have been placed on over-the-counter medications containing pseudoephedrine, which can be used to make methamphetamine. Six empty boxes of an anti-diarrhea medication were found at the scene. It's also being used to replace methadone and help curb drug withdrawal.

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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