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.

Alosetron Risk Evaluation and Mitigation Strategies Paid Survey for Women Using Alosetron (Lotronex) Opens January 3, 2018

December 28, 2017

IBS Impact has received this notice directly from Alosetron Risk Evaluation and Mitigation Strategies Program on behalf of the U.S. FDA, and is posting at the program’s request.  This is paid survey for women who have taken alosetron (Lotronex) for IBS-D anytime in the last 12 months. The exact text provided to IBS Impact follows in italics:

The Alosetron Risk Evaluation and Mitigation Strategies (REMS) Program is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product. The manufacturers/sponsors of the program have a regulatory obligation to conduct a knowledge survey for female patients in the US who have taken alosetron within the last twelve months. Patients that meet the criteria for inclusion in the survey will receive $50 for completing the survey. The survey takes about 30 minutes and can be taken either online or by phone with a call center representative. Survey responses are aggregated and anonymized. No protected health information is required for the survey or provided to FDA or any prescribers. The survey opens on January 3, 2018. If you are a female patient in the US who has taken alosetron within the last twelve months, please call us at 1-844-267-8675 to take the survey.
The Alosetron REMS Program

Alosetron, also commonly known by the brand name Lotronex, is a prescription medication with FDA approval in the United States for women with severe diarrhea-predominant irritable bowel syndrome. Historically, because of past reports of serious and sometimes life-threatening risks when misused, alosetron was only available to those women for whom all other interventions had been ineffective or inappropriate, and there were tight restrictions designed to ensure and monitor patient and physician education and safety. After many years, in January 2016, the FDA lifted some of these restrictions, making alosetron more readily available, but as the medical risks remain, it is important that the FDA be aware of users’ experiences with and level of knowledge about this medication. IBS Impact encourages women recently or currently using alosetron to participate. Please address any questions or concerns about the survey directly to Alosetron REMS.

U.S. Food and Drug Administration Issues Drug Safety Communication for IBS-D Medication Eluxadoline (Viberzi), March 2017

March 15, 2017

Today, March 15, 2017, IBS Impact learned via IFFGD social media that the U.S. Food and Drug Administration (FDA) issued a drug safety communication for eluxadoline (also known by the brand name Viberzi), currently used in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. This warning applies specifically to people without a gallbladder, whom the FDA advises should not take eluxadoline (Viberzi). There is an apparent high risk of serious pancreatitis, which has resulted in many reported cases of hospitalization and two deaths.

According to the FDA warning notice issued today, as of February 2017, in the 21 months since eluxadoline’s FDA approval in May 2015, the FDA received 120 reports of serious pancreatitis or death. 76 of the 120 patients reported required hospitalization and 2 of them died. In 68 of the patients, it is known whether or not they had a gallbladder. 56 did not have a gallbladder, including the 2 individuals who died. 22 of the 120 cases of serious pancreatitis or death reported additional complications. As a result, the FDA is advising that those with IBS-D who do not have a gallbladder not be prescribed eluxadoline (Viberzi) at this time. For physicians, the drug safety communication includes several suggestions of alternative over-the-counter and prescription medications for IBS-D.

The FDA is working with the pharmaceutical company Allergan to address the safety concerns and urges patients and physicians to report any adverse events to the FDA.  There are no announced changes in safety concerns or recommendations regarding eluxadoline (Viberzi)  for those individuals who do have a gallbladder.

IBS Impact urges readers who have IBS-D and no gallbladder and are currently taking eluxadoline (Viberzi) to consult their physicians promptly. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.

U.S. Food and Drug Administration Approves Eluxadoline and Rifaximin for IBS with Diarrhea

May 30, 2015

Earlier this week, on May 27, 2015, the U.S. Food and Drug Administration approved two new medications, eluxadoline (to be known by the brand name Viberzi) and rifaximin (known by the brand name Xifaxan)  for use in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. Both medications have met the FDA’s safety and effectiveness standards and reduced symptoms of IBS-D for subsets of study volunteers in multiple large, double-blind, placebo controlled clinical trials. Neither Viberzi nor Xifaxan is approved for use in children, and there is no known information at this time regarding potential future availability in countries other than the United States.

Viberzi is an oral medication to be taken with food twice daily. It is a mixed opiod receptor agonist designed to lessen bowel contractions. There are several reported possible side effects and it is not appropriate for those with a history of bile duct obstruction, pancreatitis, severe liver impairment, severe constipation or those who consume more than three alcoholic drinks daily. As Virberzi is a narcotic, the FDA expects it to be classified as a controlled substance. It is manufactured by Panteon Pharmaceuticals and is to be distributed by Forest Laboratories. It is projected to be available for doctors to prescribe to patients by early 2016.

Xifaxan is an antibiotic that is not absorbed in the gut and is believed to change the bacterial composition of the gastrointestinal tract. It is meant to be taken by mouth three times daily for 14 days at a time. There are some risks of side effects, but it is generally considered safe, although it also should not be used by those with severe liver impairments or along with certain other medications. In addition, research shows an eventual relapse rate of almost two-thirds among volunteers in the most recent Xifaxan clinical trials. In those individuals for whom IBS-D symptoms return after use of Xifaxan, the FDA has deemed up to two 14 day periods of re-treatment appropriate.

This was second application for approval of Xifaxan for IBS-D. In 2011, the FDA denied the first request, citing concerns about the high relapse rate and requesting more studies. Xifaxan is currently available in the United States for other conditions, and has been prescribed “off label” for use in IBS-D by some physicians. While this practice is legal, this week’s official approval for use in IBS-D will allow Salix Pharmaceuticals to market the medication specifically for irritable bowel syndrome with diarrhea, thereby presumably increasing availability and awareness among physicians and people with IBS-D. Further details on this approval can be found at the reputable links below.

The original FDA press release about Virberzi and Xifaxan.

International Foundation for Functional Gastrointestinal Disorders (IFFGD) summary on Viberzi

IFFGD summary on Xifaxan

Lengthy, detailed article with sources, “New Meds OK’d for Hard-to-Treat IBS With Diarrhea” by Kathleen Doheny, WebMD Health News, May 28, 2015

As many in the IBS community are aware, FDA-approved prescription medications specifically for irritable bowel syndrome of any subtype are extremely limited, and no single treatment, whether it is medication, diet, psychological interventions, or others, proves appropriate or effective for every individual with IBS, even those with similar symptom patterns. The only prescription drug specifically for IBS with diarrhea, alosetron (Lotronex), was approved for use only in women with IBS-D in 2000 but was quickly withdrawn from the market within months due to reports of serious side effects including several deaths. According to The New York Times at the time, in 2002, after advocacy from the IBS community, Lotronex was reintroduced only under significant restrictions for use in those women with very severe IBS-D for whom no other treatments are effective. IBS Impact is pleased that those with diarrhea-predominant IBS will soon have two safer and more widely available options in Viberzi and Xifaxan, and hopes that research on these two medications and others in development will continue.

We urge those who are considering either Viberzi or Xifaxan to read the available information, to familiarize themselves with the benefits and risks and to consult their own doctors as to if either medication is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular treatments, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.

Registration for Food and Drug Administration May 2015 Public Meeting for IBS, GERD, Gastroparesis, Chronic Idiopathic Constipation Patients Now Open

February 8, 2015

In April 2013, the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, announced that the U.S. Food and Drug  Administration had chosen three functional gastrointestinal and motility disorders to be included in its  “patient focused initiative.” (See the May 1, 2013 blog post.) The FDA is responsible for the review, approval and regulation of medications in the U.S.  The entire initiative was scheduled to take place over five years and include 20 chronic medical conditions that, based on several factors  the FDA considered sufficiently serious to warrant increased attention and drug development. The three digestive disorders, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) with regurgitation on proton pump inhibitors, and gastroparesis, were among the 16 diverse medical conditions in total that were selected during the first round. Another functional GI disorder, chronic idiopathic constipation (CIC) has since been added. The program involves public meetings and other means for the FDA to hear experiences from people affected by the selected conditions.

IFFGD/DHA has now announced that the FDA will hold one of these meetings on Monday May 11, 2015 from 1:00 pm to 5:00 pm Eastern time at the FDA campus in Silver Spring, MD. People with IBS, GERD that does not respond to standard treatments, gastroparesis and/or chronic idiopathic constipation (CIC) may now register to attend in person, attend through online webinar, or to submit comments online through the FDA comment docket. Registration will close on May 1. Further information can be found at the link below.

FDA May 11, 2015, Public Meeting on Functional GI Disorders Patient Focused Drug Development

Along with IFFGD/DHA, IBS Impact encourages people affected by the above conditions to consider participating in the public meeting or submitting comments, which is a unique opportunity to influence future FDA directions and policies regarding these disorders. It is hoped that the representation of four functional GI and motility disorders in the patient focused initiative will create other opportunities for our community and pave the way for many long-term, positive and systemic changes for us all.

U.S. Food and Drug Administration (FDA) Releases Warning About Sodium Phosphate Laxatives

February 3, 2014

An announcement from IFFGD recently alerted us to the fact that the U.S. Food and Drug Administration (FDA) recently issued expanded warnings regarding over the counter oral or rectal laxatives that contain sodium phosphate, due to increased risks of severe side effects or death in certain groups of users. Currently, labels state to take a maximum of one dose per day for three days. However, if the first dose is ineffective in relieving constipation, consumers should not continue taking the laxative product.

The updated cautions, which are not yet on product labels, now advise adults over the age of 55, as well as adults with, or caregivers of children with, kidney disease, heart disease, dehydration, colon inflammation or who are taking “diuretics or fluid medicines; angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure; angiotensin receptor blockers (ARBs) used to treat high blood pressure, heart, or kidney failure; and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen”  to consult a physician or other health care professional before using over the counter sodium phosphate-based laxatives. Such products are marketed in the U.S. under the Fleet brand name and other generic or store versions.

This change in FDA advice is the result of its review of 54 cases of serious adverse effects, including dehydration, electrolyte imbalance and kidney damage, which were ultimately fatal for 12 adults and one child in this group. As not all instances of side effects are necessarily reported to the FDA, the press release states that a precise rate of these negative outcomes is not known. For more information, see the links in the first paragraph of this post.

IBS Impact is a grassroots effort by people with IBS that focuses on awareness and advocacy, not treatment.  We do strive to provide information and resources that are  reputable, accurate and balanced to the extent of the current scientific knowledge of experienced professionals in the field of IBS and functional gastrointestinal disorders, and to encourage others with IBS and their families to make fully informed decisions that are right for their own situations. Readers with specific questions about this warning in relation to their own IBS or other condition that causes constipation are encouraged to consult their own doctors and other health care providers.

U.S. Food and Drug Administration (FDA) Sets Standard for “Gluten-Free” Labeling

August 7, 2013

On August 2, 2013, the U.S. Food and Drug Administration (FDA) issued a standard definition for the use of the terms “gluten-free”, “free of gluten”, “no gluten” and “without gluten” in voluntary food labeling. Gluten is a type of protein found naturally in wheat, barley, rye and hybrids using these grains. From now on, the above terms may only be used if the gluten content is less than 20 parts per million. Food manufacturers who do not already meet this standard have up to one year from this ruling to have their labels comply.

This change is most relevant to Americans with celiac disease, an autoimmune disorder also sometimes known as celiac sprue or gluten-sensitive enteropathy or GSE, who must strictly avoid gluten to avoid damage to the small intestine and other potentially serious medical complications. However, this information may also be useful to some subsets of people with irritable bowel syndrome.

Firstly, some symptoms of celiac disease are similar to some symptoms of irritable bowel syndrome and some individuals who may actually have celiac disease may currently be misdiagnosed with IBS. In 2009, the IBS Task Force of the American College of Gastroenterology recommended, as part of best practices for medical care for IBS, that patients whose symptoms are consistent with IBS with diarrhea (IBS-D) or mixed/alternating IBS (IBS-M or IBS-A) be tested for celiac disease. (See page S3.) However, this may or may not have occurred, especially in people diagnosed with IBS prior to that recommendation. According to a July 29, 2013 post by About.com IBS Guide Barbara Bradley Bolen, PhD, a journal article in Scandinavia reported on a study in that region of Europe showing that many study participants with celiac disease were initially wrongly diagnosed with IBS, leading to a delay in proper treatment.

Secondly, some individuals, including some with IBS, who test negative for celiac disease do anecdotally report that their symptoms have improved when they have gone gluten-free. Various research studies in very recent years have acknowledged the probable existence of non-celiac wheat sensitivity in some people, but scientific evidence is still conflicting or inconclusive as to the prevalence and nature of the problem, whether the intolerance is to gluten or other components of wheat, or appropriate management of the condition.

Thirdly, the low FODMAP diet, originally developed in Australia, has received increasing interest and research internationally as a successful option for some people to manage IBS. A component of the low FODMAP strategy is to reduce or eliminate wheat because it contains fructans, a carbohydrate that may be problematic and trigger IBS symptoms for some people. As Patsy Catsos, a registered, licensed dietitian in private practice in Portland, Maine who specializes in the low FODMAP approach states on her blog linked earlier in this paragraph, gluten and fructans are not the same thing. However, for most people avoiding wheat for low FODMAP purposes, gluten-free labeling can also make selecting appropriate foods a bit easier.

It should be noted that while dietary modifications are helpful in reducing symptoms for many people with IBS, “safe” and “trigger” foods vary from individual to individual. Some people with IBS find that they are not significantly helped by diet at all.  Diet does not cause IBS and there is no single “IBS diet” that helps everyone. For more on “Diet for IBS,”please see the linked video from the University of North Carolina Center for Functional GI and Motility Disorders Expert Update on Treatments for Functional GI Disorders conference in June 2012. The presenter is Erin Slater, RD, LDN, clinical dietitian and also a person with IBS, who also shared her experiences in a PBS television program mentioned on the IBS Impact blog on December 10, 2012.

IBS Impact does not advocate any particular diet or treatment option. We do strive to provide information and resources that are  reputable, accurate and balanced to the extent of the current scientific knowledge of experienced professionals in the field of IBS and functional gastrointestinal disorders, and to encourage others with IBS and their families to make fully informed decisions that are right for their own situations. It is hoped that the new FDA ruling proves helpful to those in the IBS community who believe they benefit from avoiding gluten or wheat.