Soon enough, U.S. grocery stores and pharmacies may carry a lot less of a popular over-the-counter anti-diarrhea drug. That’s the latest recommendation from the Food and Drug Administration (FDA), which is escalating its efforts to reduce the carnage of the opioid crisis.
On Tuesday, the FDA announced it would take steps to limit the public’s access to loperamide, an opioid and the active ingredient of Imodium AD along with other antidiarrheals. It is pushing manufacturers to change their packaging as well as lower the amount of doses available per product unit. This might include switching entirely to a blister pack model, where pills are individually wrapped, and ensuring that each product only contains a two-day supply. Currently, Imodium AD comes in both pill and liquid form, with pills sold in anything from a blister pack to a large bottle.
Ordinarily, loperamide only works on the digestive system, slowing it down temporarily. But in very high doses, it can also affect the central nervous system, just like the opioids people get addicted to. In recent years, the FDA and doctors have noticed people using loperamide—along with other drugs—to achieve a high; others have instead used it as a home remedy to stave off withdrawal symptoms, as an unapproved alternative to drugs like methadone.
Unfortunately, this experimentation isn’t particularly safe. There have been heart problems and even deaths linked to loperamide abuse. There’s no official data as to how often people are actually misusing loperamide, but it seems to have become more prominent in the wake of policies that have tried to limit the availability of other legal opioids. In 2016, the FDA issued a public safety advisory on loperamide. It also added a warning label concerning its heart risks to both prescription and over-the-counter drugs containing loperamide.
The packaging change isn’t the only one involving loperamide that the agency is seeking, either.
“I also plan to reach out to those who distribute loperamide online, through retail web sites, to ask them to take voluntary steps to help us address this abuse issue,” FDA chief Scott Gottlieb said in a statement Tuesday. “Today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.”
Johnson & Johnson, the manufacturers of Imodium AD, did not immediately respond to a request for comment regarding whether they would comply with the FDA’s recommendations.
[FDA]
