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.

American Neurogastroenterology and Motility Society Facebook Live Chat on Pediatric Abdominal Pain, February 22, 2018

January 31, 2018

The American Neurogastroenterology and Motility Society (ANMS) has announced that it will be holding a Facebook Live chat from 7:00-8:00 PM Eastern Time on Thursday, February 22, 2018 on the subject of “Tips for Parents to Manage Their Child’s Stomach Aches ” The chat moderator will be Miranda van Tilburg, PhD Associate Professor in Clinical Research at Campbell University College of Pharmacy and Health Sciences in Buies Creek, North Carolina, USA. Dr. van Tilburg is a leading researcher on pain and gastrointestinal disorders in children and adolescents, including irritable bowel syndrome (IBS) and centrally mediated abdominal pain syndrome, also known as functional abdominal pain or recurrent abdominal pain.

ANMS’s public Facebook page is American Neurogastroenterology and Motility Society.

IBS Impact encourages parents, guardians and caregivers of youth with chronic gastrointestinal conditions involving pain.to make time to attend and participate in this open, public chat, which allows one to interact directly with a physician who is associated with a leading center for pediatric functional gastrointestinal and gastrointestinal motility research and clinical care. Participants will have the opportunity to  ask questions and/or give feedback about general needs and concerns regarding children and adolescents with these conditions.

A reminder to all interested parties: All information shared on Facebook in connection with this chat will remain online, potentially accessible to the public indefinitely and is designed to address issues of general interest within the scheduled hour. It is not an appropriate venue to seek diagnosis or treatment of an individual medical situation from Dr. van Tilburg or  other professionals who may be participating in the discussion. However, it is a quality, evidence-based and unique opportunity to further one’s self-education on the complex topic of chronic abdominal pain in children, for which there is generally less awareness. IBS Impact thanks Dr. van Tilburg and ANMS for making this chat available, with best wishes for a successful chat.

IBS Impact’s Top 25 (or 27!) Countries and Top 15 (or 16!) Posts of 2017

January 1, 2018

For this first week of the New Year, IBS Impact is once again participating in the common December-January blogger tradition of highlighting popular posts and interesting blog statistics from the year just past.

This blog reached readers in 140 countries and territories during 2017, which is an annual record just short of the cumulative total is 157 for the six years WordPress has made country statistics available to individual blog owners. Both the number of visitors and total number of hits increased again this year to record levels, despite a similar number or fewer posts published compared to previous years.

While, as usual, most of the top 6 countries this year are ones where English is an official or major secondary language, total blog hits span every continent, underscoring that IBS is a global problem, not the common, inaccurate stereotype of it as a nuisance disorder caused by overindulgent North American diets and lifestyles. A list of the top 27– two ties between countries this year– better reflects the diversity of countries of origin represented, which appears to change somewhat every year. It is hoped that the vast majority are legitimate visits, even from those who might not have been searching specifically for information about IBS, and not simply potential spammers. In order, the countries are:

1.  United States

2. United Kingdom

3. India

4. Canada

5. Italy

6. Australia

7. Japan

8. Saudi Arabia

9. Brazil

10. Taiwan

11. South Korea

12. Netherlands

13. Indonesia

14. Mexico

15. Vietnam and Turkey (tie)

16. Sweden

17. Thailand

18. Germany

19. Egypt

20. Philippines

21. Singapore

22. Hong Kong

23. Romania and Pakistan (tie)

24. Colombia

25. Belgium

Below are the top 16 (one tie) individual posts that received the most hits during 2017. The #1 post, on the Rome IV criteria, was published in early June 2016, and the number of hits on this important topic is about  15 times that of the #2 post. The #2 post, on functional gastrointestinal disorders like IBS being classified as service-connected disabilities for U.S. military veterans, was originally published in 2011, soon after the inception of this blog, and held the top spot consistently every year and cumulatively from 2011 through 2015 until the release of the Rome update in May 2016.

Most of the posts in the list were first published in 2011 through 2016. However, they continue to attract attention because they address topics that are of ongoing concern to people with IBS. Perhaps longtime readers can refresh their memories and newer readers will discover something interesting and useful. Please note that since this blog has been in continuous existence for 7 1/2 years, some links embedded in posts that are several years old, while valid at the time of publication, have inevitably become out of date. You may find the updated or a similar current resource on our main website. If not, feel free to leave a comment, and IBS Impact or other readers may be able to assist. In order, the posts are:

1. New Rome IV Diagnostic Criteria for Irritable Bowel Syndrome (IBS) Unveiled May 2016, June 9, 2016

2. Functional Gastrointestinal Disorders/IBS Considered Presumptive Service-Connected Disabilities for U.S. Gulf War Veterans,  August 12, 2011

3. Irritable Bowel Syndrome (IBS) and a Debate on “Can’t Wait” Cards,  November 25, 2012  Please note that the blog originally linked in the above post as a basis for discussion no longer exists on WordPress.com. However, the ideas raised and the invitation by IBS Impact for readers and the IBS community to continue to discuss related concerns are still valid.

4. The Americans with Disabilities Act (ADA) and Irritable Bowel Syndrome (IBS), July 30, 2012

5. Education Laws and Resources for Students with Irritable Bowel Syndrome (IBS), August 27, 2013

6. Public Restroom Access and Irritable Bowel Syndrome (IBS), February 21, 2012

7.  Restroom Access Act (Ally’s Law) Updates in Maryland and Maine, May 10, 2013

8. Representative Joyce of Ohio Co-Sponsors HR 2311 for Functional Gastrointestinal and Motility Disorders, June 28, 2016 Please note that HR 2311 has since been reintroduced in the U.S. House of Representatives for 2017-2018 as HR 1187.

9. 15 Common Misconceptions That Shouldn’t Exist About Irritable Bowel Syndrome (IBS), November 8, 2013

10.  Irritable Bowel Syndrome (IBS) is Not a Diagnosis of Exclusion, October 9, 2011

11. Irritable Bowel Syndrome (IBS) and the Myth of a Cure, June 19, 2014

and April is Irritable Bowel Syndrome (IBS) Awareness Month 2017, April 1, 2017

12. Resources for People with Irritable Bowel Syndrome (IBS) in Australia 2017, February 16, 2017

13. New Rome IV Diagnostic Criteria for Irritable Bowel Syndrome (IBS) Will Include Individualized Clinical Profiles, October 11, 2015

14. Massachusetts Enacts Restroom Access Act,  August 20, 2012

15. Designer Mychael Knight Could NOT Have Died from Irritable Bowel Syndrome (IBS), October 23, 2017

This blog was begun in July 2011, a few months after the launch of the main IBS Impact website, and a bit over a year after the inception of IBS Impact itself. It is intended as a supplement to the many resources on our main site, one that can be updated relatively quickly with time-sensitive news, advocacy and clinical trial opportunities, as well as providing well-researched, scientifically reputable information on IBS and commentary on broader issues affecting the IBS community that may not be widely discussed on other sites. It is meant to be useful to a broad readership: people with IBS and related conditions, both those who may have lived with IBS for some time and those with recent onset or who are new to IBS sites online, family members and friends, health care and human service professionals who may interact with us, and the general public. We are pleased that it continues to fulfill this role.

IBS Impact wishes everyone a happy, healthy, prosperous and productive New Year and looks forward in 2018 to advances in awareness, advocacy, research, treatment and community support systems that benefit the worldwide IBS community.

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.

American Neurogastroenterology and Motility Society Pediatric IBS Twitter Chat, December 20, 2017

December 19, 2017

The American Neurogastroenterology and Motility Society (ANMS) has announced that it will be holding a Twitter chat from 6:00-7:00 PM Eastern Time tomorrow, Wednesday, December 20, 2017. on the subject of “Irritable bowel syndrome in children. What is it, and what treatments are available?” The chat moderator will be Peter Lu, MD, MS, Assistant Professor in Clinical Medicine at Ohio State University College of Medicine and physician and Nationwide Children’s Hospital GI Motility Program in Columbus, Ohio, USA

ANMS’s Twitter handle is @ANMSociety and the chat can be found using the hashtag #ANMSChat

IBS Impact encourages parents, guardians and caregivers of youth with irritable bowel syndrome. to make time to attend and participate in this open, public chat, which allows one to interact directly with a physician who is associated with a leading center for pediatric functional gastrointestinal and gastrointestinal motility research and clinical care. Participants will have the opportunity to  ask questions and/or give feedback about general needs and concerns regarding children and adolescents with IBS.

A reminder to all interested parties: All information shared on Twitter in connection with this chat will remain online, potentially accessible to the public indefinitely and is designed to address issues of general interest within the scheduled hour. It is not an appropriate venue to seek diagnosis or treatment of an individual medical situation from Dr. Lu or other professionals who may be participating in the discussion. However, it is a quality, evidence-based and unique opportunity to further one’s self-education on the complex topic of IBS, particularly IBS in children, for which there is generally less awareness. IBS Impact thanks Dr, Lu and ANMS for making this chat available, with best wishes for a successful chat.

Representative Moore of Wisconsin Co-Sponsors HR 1187 for Functional Gastrointestinal and Motility Disorders

November 26, 2017

According to IFFGD and the official Congressional legislative database Congress.gov, Representative Gwen Moore (D-WI-4) signed on earlier this month as a co-sponsor of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.

Representative Moore is serving her seventh term term in the House of Representatives. Her district, the 4th Congressional District of Wisconsin includes Milwaukee and much of the surrounding area. According to her official House website, Representative Moore  is currently a member of the House Committee on Budget, and also has a record of supporting concerns related to health, veterans and women. As discussed previously on this blog, veterans and service members deployed in the Persian Gulf region have been shown to be disproportionately affected by functional gastrointestinal disorders, of which IBS is the most common. Approximately two-thirds of adults with IBS are female. Representative Moore was also a co-sponsor of the previous versions of this legislation, HR 2239, in the 112th Congress (2011-2012), HR 842 in the 113th Congress (2013-2014) and HR 2311 in the 114th Congress (2015-2016) which did not pass. IBS Impact thanks her for her long support of the functional gastrointestinal disorders community for four consecutive Congresses since the inception of the legislative effort for this Act.

In officially supporting HR 1187, Representative Moore joins Representative F. James Sensenbrenner, Jr. (R-WI-5), who is the initial sponsor, and co-sponsors, Representatives Mark Pocan (D-WI-2), Eliot Engel (D-NY-16), Dave Loebsack (D-IA-2), Alcee Hastings (D-FL-20) Tom Suozzi (D-NY-3), and Ron Kind (D-WI-3)  If you are a constituent of any of these legislators, please take a few minutes to call, write, or contact him or her on social media to thank him or her for his  support of the functional gastrointestinal and motility disorders community.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 1187, please see the previous post from March 21, 2017 for links to the bill and more details on how to do so.  Often, it takes multiple attempts to elicit any interest from legislators, so if you do not receive a reply, do not hesitate to try again or to switch contact methods until you attract attention. Keep in mind that your Representative may be different from before because of the 2016 elections, district boundaries that may have been re-drawn, or if you have moved.

Your personal experiences as a person with IBS and/or other functional GI/motility disorders, or as a concerned family member, friend or colleague, are most effective in communicating to legislators and their staff that there are real human beings behind the statistics. However, even general expressions of support are helpful.

HR 1187 is bipartisan legislation (supported by members of both parties) and according to IFFGD discussions with IBS Impact,  is “revenue-neutral,” meaning that there will be no additional taxes or spending added to the current federal deficit if it is enacted. Discretionary funds are available at the National Institutes of Health to be allocated if Congress directs NIH, through this Act, that functional gastrointestinal and motility disorders are a priority. Congress will only do so if we, as a community, are able to show them the importance of the research, education and FDA coordination provided for in HR 1187.

NIH grants funding to researchers throughout the world, not just in the U.S., so in the long run, enactment of this Act may also benefit readers with IBS in other countries. Medical research also sometimes involves multinational teams of scientists, and in any case, study results are usually published globally, adding to the cumulative knowledge worldwide.

It is IBS Impact’s understanding that HR 1187 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 115th,  the necessary number of sponsor/cosponsors must be reached by December 2018. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 1187 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012, HR 842 in 2014 and HR 2311 in 2016. While it is quite common for legislation of various sorts to take several Congresses to pass, our continuing advocacy now can increase awareness, build momentum and perhaps accelerate passage. It is in our hands.

Check back on this blog or join IBS Impact’s Facebook page or Twitter feed for further updates on HR 1187 as they occur. Links to the social media sites can be found on the right sidebar of the blog.

GERD Awareness Week: November 19-25, 2017

November 21, 2017

This week is GERD Awareness Week. Gastroesophageal reflux disease, like IBS, falls under the broad category of functional gastrointestinal and motility disorders, and many people with IBS also have GERD. According to former VeryWell.com IBS Guide IBS Guide Barbara Bradley Bolen, PhD, and Emmy Ludwig, MD, some studies show that up to 81% of people with IBS report some symptoms of GERD and vice versa, but that among those with actual diagnoses, the overlap rate ranges from about one-quarter to one-third. GERD occurs when the lower esophageal sphincter, the valve connecting the esophagus to the stomach, fails to close completely and consistently when needed, and stomach acids and digested food inappropriately back up into the esophagus on a recurring basis. GERD is estimated to affect at least 20% of American adults, both men and women. GERD also commonly affects children of all ages, including infants. A wide variety of lifestyle factors, medical conditions and medication side effects are thought to be possible factors in causing or exacerbating GERD.

Symptoms vary from person to person and are not restricted to heartburn. Some people may not have noticeable symptoms at all until they experience complications. Some other possible symptoms of GERD are: belching, coughing, hoarseness, difficulty or pain in swallowing, excessive saliva, the sensation of food sticking in the esophagus, chronically sore or irritated throat, laryngitis, inflammation of the gums, erosion of tooth enamel, bitter taste in the mouth, and bad breath. Chest pain may also be a symptom of GERD, but should receive immediate medical attention to rule out the possibility of cardiac problems or other serious conditions. Other possible symptoms of GERD occurring more than once a week or the need to use non-prescription heartburn/reflux medications for more than two weeks without resolution should be discussed with a doctor

Relative to other functional gastrointestinal and motility disorders, GERD is generally considered by physicians and many affected people to be quite treatable by a variety of lifestyle and diet modifications, prescription medications and/or surgery. Many people have mild GERD and, with appropriate medical care, are at low risk of serious complications, but untreated GERD can lead to inflammation, erosion or narrowing of the esophagus or in a small percentage of cases, Barrett’s esophagus, cell changes that heighten the risk of esophageal cancer. According to a brief extract of a longer IFFGD publication by Carlo DiLorenzo, M.D. of Children’s Hospital of Columbus and Ohio State University, Dr. Mark Glassman, MD of Sound Shore Medical Center in New Rochelle, New York, and Paul Hyman, M.D. of Children’s Hospital in New Orleans, Louisiana, some children with GERD and other conditions such as asthma, cystic fibrosis, abnormal lung development due to premature birth, muscle or nerve disorders affecting swallowing, or esophageal dysplasia, are at risk of GERD complicating those conditions.

Please see the following links for further information and resources and the original source for Drs. DiLorenzo, Glassman and Hyman’s work mentioned above.  IFFGD also offers downloadable GERD, IBS and functional GI disorder awareness posters for anyone to hang or distribute in his or her own community, that are accessible from the IFFGD links posted here.

 GERD Awareness Week section from the IFFGD About GERD website

Pediatric GERD section from the IFFGD About Kids GI website

Medline Plus page on GERD  (subunit of the U.S. National Institutes of Health)

In addition to encouraging accurate awareness of irritable bowel syndrome, IBS Impact encourages awareness of related conditions that are known to often overlap with IBS, as improvement in symptom management, treatment options, public awareness and social resources may have overlapping positive effects that improve quality of life for some people with IBS.