Linaclotide Approved for Irritable Bowel Syndrome With Constipation in Europe as Constella

November 30, 2012

UPDATE: 06/09/2013– As of mid-May 2013, Constella is available to be prescribed in the United Kingdom. See the May 22, 2013 article by Pharma Times Online Thank you to Dr. Barbara Bradley Bolen, About.com IBS Guide for alerting us to this news.

 

On November 28, 2012, Ironwood Pharmaceuticals and Almirall, S.A. announced that the European Commission has approved linaclotide, to be known in Europe as Constella, for use by adults with moderate to severe irritable bowel syndrome  with constipation (IBS-C), both men and women. The new medication, which is an oral capsule to be taken once a day, is expected to be available in European Union countries sometime in the first half of 2013, and is the first prescription medication approved specifically for IBS-C.  According to the press release on Constella from Ironwood, there are an estimated 15 million adults with IBS-C within the European Union. The press release also includes a brief description of what the medication is and how it is believed to work.

Linaclotide was approved in August of this year by the U.S. Food and Drug Administration for adults with IBS-C or chronic idiopathic constipation. In the United States, the brand name is Linzess, and it is to be distributed by Ironwood Pharmaceuticals and Forest Laboratories. For further details, please see the September 1, 2012  post.

As many in the IBS community are aware, 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. IBS Impact is pleased that those with constipation-predominant IBS in various countries in Europe will soon have another option, and urges those who are considering linaclotide to read the available information, to familiarize themselves with the benefits and risks and to consult their own doctors as to if linaclotide 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.


Irritable Bowel Syndrome (IBS) and a Debate on “Can’t Wait” Cards

November 25, 2012

Earlier this week, an anonymous blogger, who apparently has IBS, posted a thought-provoking entry entitled “The IBS Card– Good or Bad Concept?” Such cards are also popularly known as “can’t wait” cards and are sometimes offered to members by organizations representing various medical conditions that frequently cause an unpredictable, urgent need to use a toilet. The design of the cards varies with the individual organization, but generally, such cards state that the person has a medical condition and politely asks others to allow him or her to use the restroom or washroom immediately. While they do not confer legal protections in most localities, the cards are meant to assist people with relevant medical conditions who carry one to communicate their need quickly and courteously, perhaps forestalling lengthy public explanations. Because these cards also usually have the logo and/or contact information of the issuing organization, presumably those who are shown a card may perceive a bit more legitimacy to the request, and it becomes an awareness tool as well. In the IBS community, “can’t wait” cards are known to be offered by the IBS Network in the United Kingdom and the Irritable Bowel Information and Support Association in Australia (IBIS). To IBS Impact’s knowledge, they are not currently available through IBS organizations in the United States or Canada, though the concept is widely used by various inflammatory bowel disease (IBD) organizations and also the Interstitial Cystitis Association in the U.S. Interstitial cystitis is a chronic, painful bladder condition that is among several conditions commonly known to overlap with IBS.

The author of the post in question appears to believe that “can’t wait” cards are not a good idea for IBS, wondering if the average person would really allow someone with a card to move ahead in a line or queue for a public toilet, as everyone in line has a need to use it. He or she also states,”IBS is generally a very personal and embarrassing condition, thus advertising it with a card seems peculiar.” Later in the post, the blogger writes, “Without doubt many people would think the IBS card a good idea,  although it does sound as though it was created by people who thought it would be a good idea, but did not consult sufferers.”

Julie Thompson,  registered dietician and advisor to the IBS Network who writes the Clinical Alimentary blog and is also known by the online handle Jules_GastroRD, left a comment on this blog entry which offers a counterpoint. She states that using a “can’t wait” card, if available, is a personal choice, and that such cards may help people with IBS gain access to toilet facilities usually restricted to staff. She also notes that other organizations offer these cards with apparent success, as mentioned above, and asks if the anonymous blogger knows for a fact that people with IBS were not consulted regarding this issue.

From IBS Impact’s own interactions and advocacy in the IBS community over time, it is clear that, as with almost everything concerning IBS, responses vary greatly among individuals. The question of why “can’t wait” cards specific to IBS are not available in the U.S. or Canada comes up periodically in other  IBS forums and in incoming searches and inquiries to this blog and the main IBS Impact site. This blog’s posts on the Restroom Access Act, also known as Ally’s Law, which address medical conditions and employee-only restrooms in thirteen U.S. states, are among those that generate relatively high numbers of hits. (See February 21, 2012, August 20, 2012 and November 2, 2012) Yet, we have also received feedback from some people that they do not know if they would use such a card, or that they have one for another condition or in a country where IBS-specific cards are available, but rarely or never actually use it. When IBS Impact has raised the issue in the past of if members or supporters would be interested in having cards made available in more countries,  as of yet, there has never been a critical mass of responses one way or another. But this small debate between bloggers is the impetus to ask some questions of our own and to consult our peers with IBS, as suggested by the original blogger.

What do you think? Is the concept good or bad?  Do you or would you choose to use a “can’t wait” card?  If not, why not?  Is IBS truly different from or more embarrassing than other medical conditions with “bathroom issues?” Readers are invited to comment on this post. As always, you do not need to leave your name, although you are encouraged to do so if you wish. First-time commenters are automatically moderated to reduce the spam and hoaxes commonly received by blogs, but varying opinions from real IBSers are always welcome.


GERD Awareness Week: November 18-24, 2012

November 18, 2012

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 About.com IBS Guide Barbara Bradley Bolen, PhD, some studies show that over 70% 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.


Veterans With IBS and Functional Gastrointestinal Disorders: 2012 Update

November 11, 2012

Today, November 11,  is Veterans Day in the U.S., and a good time to highlight veterans’ issues. U.S. veterans  and current military service members who have been deployed in the Persian Gulf/Southwest Asia region at any time since 1990 have been shown by multiple studies to be at even higher risk of IBS and other functional GI disorders than the general population. Conservative estimates put the incidence of functional GI disorders in the general population as 25%, most commonly irritable bowel syndrome. For veterans and military service members of the Persian Gulf era, the estimate may reach as high as 40%. This appears to be in part because of the high incidence of known functional GI risk factors during active duty, such as severe stress or trauma and/or food or water contamination that results in post-infectious IBS  (IBS-PI) or other post-infectious functional GI and motility disorders.

Here is IBS Impact’s August 12, 2011 post on the recognition last year by the  U.S. Department of Veterans Affairs of irritable bowel syndrome and functional gastrointestinal disorders as presumptive service connected disabilities for Gulf War veterans.

IFFGD and its grassroots arm, the Digestive Health Alliance, have done considerable work in the past few years in advocating for federal funding and other legislative needs specific to veterans, conducting outreach to service members and veterans and encouraging those affected by functional GI  and motility disorders to participate in veteran-specific self-advocacy efforts. The Digestive Health Alliance also provides a private, password-protected community for veterans with functional GI disorders to seek support and information from DHA and their peers. Further information on all of these activites and resources can be found on the Digestive Health Alliance page for veterans.

IBS Impact encourages veterans, service members and families in the IBS and functional GI community to inform themselves on these resources and to consider participating in self-advocacy activities and we look forward to feedback from readers as to how IBS Impact may be able to support such efforts further.


The Restroom Access Act/Ally’s Law and Why It Matters to Irritable Bowel Syndrome (IBS)

November 2, 2012

UPDATE 5/10/2013: Please see the May 10, 2013  post for newer information regarding additional restroom access laws in Maryland and Maine.

In the past, IBS Impact has blogged on the Restroom Access Act, popularly known as “Ally’s Law.” This law is named for Ally Bain, a recent college graduate who has Crohn’s disease, a type of inflammatory bowel disease (IBD). Several years ago, as a young teenager, Ally had an accident in a store after her request to use the employee restroom was refused, despite her explaining repeatedly that she had an urgent medical need. After that humiliating experience, Ally resolved to do something about it, contacted her state legislator and helped to write and pass a bill to address similar situations. The first Restroom Access Act was signed into law in Ally’s home state of Illinois in 2005. Since then, with continued public advocacy by Ally and others, similar laws have been enacted in twelve other states: Colorado, Connecticut, Kentucky, Massachusetts, Michigan, Minnesota, Ohio, Oregon, Tennessee, Texas, Washington State and Wisconsin, and have been considered in several other states and countries over the years. As these are individual state laws, they each vary in certain details, but most say that a “retail establishment” must give a person with an “eligible medical condition” access to an employee restroom if there is no public restroom immediately available, there are at least three employees (in one case, two) working at the time, and the facility itself or its location will not pose a safety hazard to the person or security risk to the business. Please see IBS Impact’s previous posts on February 21, 2012 and August 20, 2012 for links to text of the law in each state where one currently exists.

IBS Impact applauds Ally’s initiative. Her success in making these laws a reality is especially impressive, as she was just fourteen years old when she began her quest. She currently has wide recognition and support within the inflammatory bowel disease community, where many self-advocates and bloggers have followed suit in pressing for change that can positively affect quality of life for those with IBD and similar restroom access needs.

This week, in a guest post on the inflammatory bowel disease blog, Girls With Guts, Ally writes “The Origins of the Restroom Access Act” in her own words. While her diagnosis of IBD is different from IBS in several ways, her experience of gastrointestinal pain, unpredictable, frequent trips to the bathroom and feeling embarrassed and alone is shared by many people with IBS. She mentions how some people with IBD are similarly reluctant to come forward publicly as self-advocates, but explains why she believes advocacy is important and how her first steps in the past are continuing to yield concrete and useful results in the present and, with luck and continuing advocacy, in the future.

IBS Impact’s past blog posts on this subject have been popular, and we have received feedback from some people with IBS that newfound awareness of these laws is very appreciated, as well as sorely needed in additional states and countries. However, historically, the IBS community has not been very visible in these efforts, despite the fact that there are an estimated 30-45 million and perhaps even close to 60 million people with IBS in the U.S. alone, depending on the source, in contrast to approximately 1.3 million people with IBD, according to the Crohn’s and Colitis Foundation of America. While twelve of the thirteen existing state laws do specifically mention irritable bowel syndrome as an eligible condition, the most recently enacted, in Massachusetts, refers only to inflammatory bowel disease and “other” medical conditions which may require immediate access to a toilet. The IBS community has the tremendous numbers to be a voice alongside our peers with IBD , to insure that IBS is specifically included in each law, and to raise state legislative and public awareness of IBS in the process. We should not simply benefit from the hard work of others.  IBS Impact hopes to follow the progress of efforts in various states as they arise, and to report on them to the IBS community. We urge readers to consider getting involved, as Ally and her mother did several years ago, and we encourage comments on this blog or IBS Impact’s social media in regard to your personal experiences with needing, using or advocating for these laws.