On January 30, 2018, the U.S. Food and Drug Administration (FDA) which regulates the approval and distribution of medications in the U.S, issued a drug safety communication for the anti-diarrheal medication loperamide.  Loperamide is more commonly recognized by the public by the brand name Imodium, although it is also sold under generic and store brand labels. Because of increasing reports of life-threatening heart arrhythmia and other serious complications, primarily among those who take intentional overdoses in a self-help effort to blunt symptoms of opiod withdrawal, the FDA plans to ask manufacturers to limit the number of capsules available in packages sold over the counter.  Media coverage states that the FDA also hopes to limit the availability of generic loperamide in large quantities  sold by major online retailers. The FDA alert emphasizes that loperamide is generally safe at dosages used as directed– a maximum of 4 capsules or 8 milligrams per day for adults over the counter, and a maximum of 8 capsules or 16 milligrams a day for an adult by prescription or direction of a physician. IBS Impact adds that at this time, it is unclear from the media coverage if the FDA plans to restrict the number of packages sold to any individual in a single transaction.

This is potentially an important concern for those with irritable bowel syndrome (IBS) and their families and others with chronic gastrointestinal disorders that may cause chronic or recurring diarrhea.

Read the FDA’s drug safety communication here: https://www.fda.gov/Drugs/DrugSafety/ucm594232.htm

Read IBS Impact’s full response from its blog:

https://ibsimpact.wordpress.com/2018/02/07/u-s-food-and-drug-administration-fda-asks-manufacturers-to-limit-quantity-of-loperamide-imodium-in-packages/

Posted: February 2018