U.S. Food and Drug Administration (FDA) Asks Manufacturers to Limit Quantity of Loperamide (Imodium) in Packages

February 7, 2018

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 warning 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. Quoting the FDA commissioner, Dr. Scott Gottlieb, apparently from a press release used by many media sources,  the website Health Day News  reports an example package size of 8  2-milligram capsules. This would be equivalent to an adult over-the-counter maximum dosage of 8 milligrams per day for two days, which Dr. Gottlieb states is appropriate for traveler’s diarrhea. The article also states that the FDA 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. IBS is the most common functional gastrointestinal disorder/disorder of gut-brain interaction, affecting anywhere from 30-58 million Americans depending on the source. Functional gastrointestinal and motility disorder researchers commonly estimate that one-third of people with IBS have diarrhea as their predominant bowel pattern, and an additional one-third of those with IBS have a mixed bowel pattern which may shift between diarrhea and constipation. Though symptom severity varies from person to person and often even in the same individual at different times, researchers estimate that about 35% of people with IBS have moderate symptoms and 25% have severe symptoms at any given time. There is no cure for IBS and typically, symptoms must be managed for years or even several decades. Many people with IBS-D or IBS-M use loperamide on an ongoing basis for far longer than two days of traveler’s diarrhea or other mild gastrointestinal upset. An adult using the maximum “prescription” dose under doctor supervision would finish the proposed over-the-counter package in a single day.

With due respect to the important work of the FDA and the severity of the opiod abuse crisis. IBS Impact expresses concern that any limits on the availability of loperamide take into account the needs of those with chronic gastrointestinal disorders like IBS. While of course, we encourage people with IBS to seek physician diagnosis and evidence-based care when appropriate, we recognize that for a variety of reasons, this does not happen on a timely basis for many in the IBS community. Many are embarrassed to discuss symptoms with anyone, even family members or health care providers, remaining undiagnosed or self-diagnosed for years. Many people with IBS who have indeed sought medical care have encountered their share of providers who are dismissive of IBS or ill-informed of cumulative advances in research and treatment over the decades, and thus remain wary of seeking additional help for IBS. Many people with severe IBS struggle to maintain employment, quickly running through any leave time they may or may not have, or they lose their jobs entirely, further constraining time available to visit doctors for regular prescription renewals, access to employer-based health insurance, or cash flow to pay out of pocket for care if they do not have insurance. Under the most common civilian disability benefit system in the U.S. for those unable to work, Social Security Disability Income or Supplemental Security Income is each very difficult to get for IBS alone, as regulations were written decades ago before IBS was recognized as a real, potentially disabling medical condition. Even successful applications for cash benefits and accompanying medical coverage are a long process that may take several months or several years. Finally, some people with IBS are rarely able to leave their homes, either because of severe symptoms or severe anxiety about potential symptoms. Each of these common situations may pose potential barriers to accessing enough loperamide if quantities are restricted.

IBS Impact will continue to follow developments on this issue and provide an update if further details or advocacy opportunities become available.