Can Unit-Dose Packaging Reduce Opioid Abuse?

FDA Aims to Limit Packaging for Anti-Diarrhea Drug to Reduce Abuse, Misuse

The anti-diarrhea treatment is being used much like heroin or other opioids.

The U.S. Food and Drug Administration is requesting manufacturers using a common psychiatric medication to change the way in which the medication is packed, as a portion of attempts to deter its misuse amid the opioid outbreak from the States.

FDA Commissioner Scott Gottlieb, MD, said Tuesday the agency sent letters to manufacturers of the diarrhea medication loperamide - known by the brand name Imodium - requesting the over-the-counter medication be repackaged to reduce the risk of overdose.

The FDA would like to have the drug only available behind the counter, or only in smaller 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. "The FDA is requesting that sponsors of OTC loperamide - an FDA-approved product to help control short-term symptoms of diarrhea, including Travelers' Diarrhea-change the way they label and package these drugs to stem abuse and misuse that leaves us deeply concerned". One example is a single retail package containing eight 2-milligram capsules in blister packaging. "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.

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Marraffa said the FDA's action is a good first step, but won't entirely solve the problem because it's easy to buy hundreds of loperamide pills online.

The FDA is asking that Imodium or its generic counterpart, Loperamide, be packaged differently.

They published a paper in the Annals of Emergency Medicine in 2015 that described two loperamide deaths. That is what happened with products containing pseudoephedrine, which can be used to make methamphetamine. Six empty boxes of an anti-diarrhea medication were found at the scene. A police investigation indicated he had been using the drug to self-treat opioid withdrawal; authorities couldn't determine whether he died of an abnormal heart rhythm or breathing problems.

Gottlieb noted, "The FDA added a warning to the product label in the spring of 2017 to warn of ingesting high doses of loperamide, including from abuse and misuse".

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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