FDA to antidiarrheal drug manufacturers: Alter packaging, limit amount of loperamide

FDA to antidiarrheal drug manufacturers: Alter packaging, limit amount of loperamide

The U.S. Food and Drug Administration (FDA) has called upon the drug manufacturers to repackage a popular antidiarrheal medicine to limit its use and abuse. The FDA advisory comes in the wake of a recent spike in cases of overdose from diarrhea medicine loperamide, better known by the brand name Imodium. The FDA announced steps to limit access to the drug along with other antidiarrhea medicines.

As part of the initiative, the agency sent letters to the makers of Imodium and a host of other manufacturers who sell their own low-cost versions of the drug, to change their packaging and reduce the number of doses available per product unit. However, it seems that it is not just the drug packaging that the agency is after. In addition to asking the manufacturers to reduce the packaging, the agency also plans to make it harder for online retailers to make bulk orders for the drugs. Apart from asking  manufacturers of Imodium to take voluntary steps to address the issue, the FDA is also influencing doctors to prescribe shorter-duration opioid medicines.

An intentional overdose of Imodium can be dangerous

With the key ingredient being a part of the opioid family, Imodium is presently available in both pill and liquid form. The pills being sold in anything ranging from a blister pack to a large bottle.

When taken as prescribed, low dose of the drug helps temporarily slow down the digestive system and helps treat short-term symptoms of diarrhea, while an intentional overdose of loperamide can severely affect the central nervous system and lead to heart problems and death. In an attempt to stem cases of drug abuse, the agency wants to eliminate the large bottles in which the medicine is often sold.

According to the FDA, the recent action comes amid reports of serious heart problems and deaths in patients who have either taken higher-than-recommended dosage of the drug. Over the years, high doses of the anti-diarrhea medicine have been used either to get high or to help ease withdrawal.

Reducing exposure to opioids

According to FDA commissioner Dr. Scott Gottlieb, the intention of the agency was to bring a change and it started with changing the way the drug was packaged and labeled, to stem its use and misuse. He added that the packaging of the drug should now only contain a limited amount of the drug that is sufficient to treat short-term diarrhea.

While a warning had also been issued on the drug labeling in 2017, cautioning users about the dangers of misuse, the latest proposed changes are related to the drug’s packaging.

By asking the drug manufacturers to reduce the size of drug packaging, the agency aims to reduce the patients’ exposure to opioids that claimed more than 42,000 lives in 2016. As per recent reports, deaths caused due to drug overdoses in the U.S. skyrocketed, reducing the average life expectancy of Americans for the second consecutive year.

Seeking help

When used as prescribed, medicinal drugs save lives, but when their easy access is abused, it leads to dependency, addiction, and in some cases it can be fatal. One of the most poorly recognized forms of chemical dependency has been addiction to prescription drugs. A nationwide crisis, it calls for a comprehensive treatment for prescription drug abuse that involves a holistic combination of medications and behavioral therapies.

At the Prescription Drug Abuse Helpline of California, we offer free consultation to help you or your loved ones find the best treatment program at the finest prescription drug rehab centers specific to your needs. For those struggling with addiction to prescription drugs, call our prescription abuse helpline number (855) 738-2770 and speak to our counselor today. You can even chat online with our representatives for any further assistance.