Anti-diarrhea drug abuse contributing to death rates in the U.S. and the U.K., FDA suggests smaller bottles

Government regulators in the United States are on a mission to make anti-diarrhea pills more difficult to abuse amidst reports of increased deaths and heart problems due to the drugs.

Loperamide, which is marketed and sold as Imodium, slows down gut movement to make stool less watery. For loperamide to be able to function this way, it makes use of an opioid, which induces a high similar to OxyContin. (Related: How to calm IBS without prescription drugs.)

On Tuesday, January 30, a 23-year-old British woman was declared dead after taking a “high level” dose of Imodium, one year after a 27-year-old dad perished due to the same cause.

The Food and Drugs Administration (FDA) is urging manufacturers of loperamide to package it in smaller bottles, to avoid instances of overdose. Specifically, the agency wants manufacturers to make sure the packages contain only a limited amount of the drug, such as eight tablets per packet, just enough to use for short-term diarrhea.

At present, generic versions of loperamide are sold in packets of up to 200 tablets.

“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,” FDA Commissioner Dr. Scott Gottlieb said.

“Today we sent letters to the OTC [over-the-counter] manufacturers requesting that they implement changes consisting of packaging limitations and unit-of-dose packaging. We asked the manufacturers to take the necessary steps to implement these changes in a timely fashion to address these public health concerns.”

The FDA said it also aims to urge online retailers to set guidelines for bulk buyers of the anti-diarrhea medication. “We’re leaving no stone unturned,” Dr. Gottlieb said.

Imodium is marketed by New Brunswick, New Jersey-based multinational pharmaceutical and consumer packaged goods manufacturer Johnson & Johnson.

In a study that was conducted in 2017, it was found out that 15 deaths were associated with the use of the drug between the years 2010 and 2016. In 2016, the FDA released an agency warning that high dosage intake of loperamide can result in heart problems and can cause death.

Dr. Robert Glatter, assistant professor of emergency medicine at Northwell Health in New York, welcomed the move that the FDA is taking in relation to the anti-diarrhea drug crisis. “It’s one of the many steps that has to occur. I think it starts with public messaging, education, and a shift back to the basics about how over-the-counter medications are deemed to be safe but, in certain cases with abuse, can kill you.”

Dr. Glatter said loperamide misuse is prevalent in adolescents. “A lot of teens are aware of this. They use different nicknames. Parents and teachers, they owe it to their children to let them know that they’re aware that loperamide abuse can kill you.”

In earlier years, health experts had asked to restrict the sale of the medicine similar to pseudoephedrine, the decongestant in Sudafed which can be chemically processed to make methamphetamine. Now, pharmacies limit purchases of Sudafed and related medication, and require a prescription of such drugs before selling them.

However, restrictions such as the one that have been made for Sudafed generally require changes to federal law from Congress.

The FDA and other federal government agencies have long been trying to stifle an ongoing nationwide opioid epidemic which was initially dominated by prescription painkillers but now includes illegal drugs like fentanyl and heroin.

Sources include:

DailyMail.co.uk

Fox2Now.com

StatNews.com