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The US Food and Drug Administration has announced that it requested a label and package change for products that contain loperamide.
It is doing so to try and prevent substance abuse through opioid health products. This includes Imodium, an over-the-counter (OTC) anti-diarrhea drug, which helps cure short-term symptoms of diarrhea.
Loperamide is an opioid-based substance, which has started and is increasingly more abused in the US, according to the FDA statement.
There are around 11.5 million Americans who took substances with opioid effects this last year alone. About 40 Americans reportedly die every day due to opioid substance abuse.
Those who suffer from withdrawal symptoms or who are looking for euphoric opioid-effects seemingly use this substance in significant quantities. In fact, Imodium is sometimes also called the poor man’s methadone.
The FDA requests all OTC manufacturers to change the packaging of the anti-diarrhea drug so that it only contains a safe dosage. A single package should hold a maximum of eight 2-milligram capsules in blisters.
Imodium is an FDA-approved product, which can be taken at a maximum dose of 8 milligrams (OTC) or 16 milligrams (prescription) by adults. When taken in larger doses, it can lead to heart problems and even death.
Context and Prospects of the Anti-Diarrhea Drug Change
This change comes after a warning that the FDA issued back in the spring of 2017. It requested a modification of the product label so that this would now include the risks attached to taking high doses. However, the need for another initiative was imperative.
“Appropriate prescribing practices, better packaging, and education are important steps within our statutory authority to help address the human and financial toll of opioid addiction. They can reduce harm while still providing effective pain management protocols”, declare FDA representatives in the statement.
The package change initiative also targets the online distributors of loperamide. According to experts, they should also take the necessary steps to limit drug abuse. They also want to eliminate large volume containers of this anti-diarrhea substance.
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