Virtus Pharmaceuticals Initiates Voluntary Recall of Some U.S. Hyoscyamine Tablets -Sept. 2016

September 19, 2016

IBS Impact has recently learned of a voluntary recall of some batches of some forms of hyoscyamine tablets distributed by Virtus Pharmaceuticals. Hyoscyamine (Levsin, Levbid and other various brand names) is an anticholernergic agent prescribed for some adults and children with IBS or related functional gastrointestinal disorders. As this is a generic medication, not all hyoscyamine comes from Virtus, but readers are advised to check.

The recall involves certain lots of sublingual tablets, oral disintegrating tablets and regular tablets in the 0.125 strength only. These lots have been distributed throughout the  United States and the commonwealth of Puerto Rico since March 2016. According to the official FDA recall report, Virtus initiated this recall because some of the tablets contain either too little or too much hyoscyamine. A small portion of the affected lots also have incorrect expiration dates. There have been a few reports of various adverse symptoms from those lots that contained an unintended overdose. While the individuals required medical treatment, none of the reported situations appeared to be life threatening, and as far as is known, have resolved. Full details on the affected lot numbers and reported symptoms are in the link above. People with medication from these lots are advised to stop taking the medication and consult a doctor, especially if they have experienced any unusual symptoms or side effects. Contact information for both Virtus and the FDA is contained within the linked page.

IBS Impact encourages affected individuals to read the above links thoroughly and bring any questions or concerns to their own health care providers.


Are People with IBS in the U.S. Having Difficulty with Access to Certain Medications?

August 30, 2016

The pharmaceutical company Mylan has received intense negative publicity recently over significant price increases for Epipens, epinepherine autoinjectors for use in life-threatening allergic reactions. However, the University of North Carolina Center for Functional GI and Motility Disorders also shared on social media an NBC News article that claims many other Mylan-supplied prescription medications have also experienced significant price increases over time. These include dicyclomine (Bentyl), an antispasmodic used by many people with IBS  and metoclopramide (Reglan), a prokinetic commonly prescribed, among many other uses,  for  gastroesophageal reflux disease (GERD) and other gastrointestinal conditions that may coexist with IBS.  As both are generic drugs, each has several suppliers. Not all individuals using these medications receive them from Mylan, but as one generally has no control over the specific distributor used by a given pharmacy, this issue is a potential concern.

Also, a moderator of a large Internet support group passed along an August 12, 2016 blog post from the website GoodRx.com detailing the removal of numerous prescription drugs from the 2016 formulary lists of Express Scripts and Caremark. Express Scripts and Caremark are both companies that administer pharmacy benefits and mail-order pharmacy services for U.S. health insurance companies, self-insuring employers and in the case of Express Scripts, TRICARE, the insurance system for active, reserve or retired U.S. military personnel, some National Guard members, and military family dependents. The formularies are lists of specific medications approved for coverage. In the U.S.,health insurance is traditionally an employer-based benefit for the largest subset of citizens and residents, and typically,  employees have limited or no choice in the specific insurance plans offered to them and/or their families. Thus, again, one would most likely have no control over which of the two companies with which one’s insurance provider has a contract. From the linked lists, it appears lubiprostone (Amitiza), a chloride channel activator, which is FDA approved in the U.S. for use by women with irritable bowel syndrome with constipation (IBS-C), has been newly excluded from the Caremark formulary. Duloxetine (Cymbalta), a selective serotonin-norepinephine reuptake inhibitor is used by some people with IBS for pain and/or commonly coexisting depression and/or anxiety. It has also newly been dropped by Caremark. This issue would also appear to merit possible concern.

So IBS Impact asks U.S. readers, are these media reports consistent with real world experiences? Are people with IBS having problems getting access to medications they take regularly? If so, is either of these reported issues a widespread, systemic problem for individuals or certain subgroups in the IBS community? Please feel free to leave comments on this post.

 


Updates to IBS Impact.com for August 2016

August 19, 2016

Over the past few months, IBS Impact has been working on the latest round of updates to our main site. This is always a work in progress as new and useful information comes available, but this is a good time to draw readers’ attention to some of the changes.

There have also been new details and resources added in the latest news column on the left of the home page,  IBS page, advocacy page, research pageIBS studies page, resources pageIBS and children page and links page. Of particular interest are the progress of HR 2311, the Functional Gastrointestinal and Motility Disorders Research Enhancement Act, currently under consideration in the U.S. House of Representatives, and updated information for the recently released Rome IV international diagnostic criteria. A couple of new pediatric clinical trial opportunities have been added as well.

Readers interested in the most recent news, events, clinical trial and advocacy opportunities, and articles between main site updates, may follow this blog or our Facebook or Twitter feeds (links found on the lower right sidebar of this blog). Regardless of one’s interest in IBS, whether personal or professional, most users should find useful and interesting material and links. The current site reflects resources in six countries which are among the top sources of hits to the site and this blog.

Because of the redesign and transfer of the site to new hosting in the fall of 2015, some links embedded in older posts on this blog or search engine results relating to IBS Impact.com may result in error messages, but you should still reach the site itself. If so, please use the navigation links at the top of the site to reach the desired subpage.  No information that is still currently useful has been removed from the site, although in some cases, the location has changed. Only outdated details and occasional defunct links for which there is no replacement available at this time have been deleted.

Please feel free to check out the site here. Our goals with the website, blog and social media are to provide a varied range of current, scientifically accurate, reputable information and resources to people with IBS and their families and friends, and to encourage informed choices, proactive self-advocacy and public awareness of IBS, and the unmet medical or social needs many of us face as a result of IBS.

IBS Impact as an entity, is not directly affiliated with any other organization, site or research sponsor and receives no funding for the information we post on the main website, this blog or our Twitter and Facebook pages. We do welcome constructive collaboration and value the many individuals, websites, organizations and clinical and research entities who continue to support, encourage and amplify our efforts in various ways to benefit the cause of IBS awareness and advocacy worldwide.

Comments, suggestions, corrections of outdated links, article submissions, and clinical trials or surveys by researchers affiliated with academic, medical, or pharmaceutical entities or reputable organizations representing IBS or commonly overlapping conditions in any country are all welcome and will be thoughtfully considered.  A contact form can be found on the home page of the main site, or comments can be left on this blog.  Thank you to all of our readers and social media followers for your interest and participation.


Online Clinical Trial: The Effects of Food on IBS and IBD, Northwestern and Rush Universities, July 2016

July 24, 2016

The following online clinical trial seeking adult volunteers with either irritable bowel syndrome (IBS) or any form of inflammatory bowel disease (IBD) was received recently via the social media of Oak Park Behavioral Medicine located in suburban Chicago. Oak Park Behavioral Medicine is a private practice partnership of psychologist, Tiffany Taft, PsyD and social worker, Stephanie Horgan, LCSW. They specialize in providing psychological care to adults and children with chronic health conditions, including IBS and IBD. Dr Taft, who is also associated with Northwestern University Feinberg School of Medicine as a researcher into the psychosocial aspects of chronic gastrointestinal conditions, previously authored a guest post about stigma and IBS especially for this blog on April 15, 2013.

The italicized paragraphs below are a direct, complete quotation of all details available to IBS Impact at this time. Please address any questions or concerns about the study directly to Dr. Taft at the email address in the description.

Dr. Taft is collaborating with GI docs at Northwestern and Rush University to evaluate how food and diet treatments may affect the day-to-day lives of patients with Crohn’s Disease, ulcerative colitis, indeterminate colitis, or irritable bowel syndrome. If you’re interested, please read on…

My name is Dr. Darren Brenner and I’m an Assistant Professor at Northwestern University Feinberg School of Medicine. We are doing a research study to evaluate the experiences patients diagnosed with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) have with food choices and, if applicable, using diet to treat their digestive symptoms. The title of the study is “Food related quality of life in irritable bowel syndrome and inflammatory bowel disease” (NU Study STU00202950). We are looking for 300 adults. If you’re between 18 and 70 years old and have been diagnosed with IBS or IBD, you are eligible to participate.

If you are interested, please email Dr. Tiffany Taft at ttaft@northwestern.edu and you will receive an email with the study website link as well as a unique participant ID and password. If you agree to participate, you will be asked to answer several questionnaires about you, your IBS or IBD treatments, your experience with the food and diet treatments, and your mood. Your participation should take about 60 minutes. Participants may enter a drawing to win one (1) $50.00 Amazon gift card once they have completed the study. Thank you!

IBS Impact welcomes researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or related or commonly overlapping conditions, to contact us directly with additional studies or surveys they wish to be considered for posting. A contact form is available on the main IBS Impact website.

IBS Impact makes these announcements available for general information, and encourages its members and site visitors to make their own individual, informed choices about their potential participation. Additional studies can be found by clicking on the Research– Clinical Trials sub-category in the right sidebar of this blog on our main website IBS studies page. Please be sure to check the date at the top or bottom of a given post, as many posts from this blog remain visible in search engines for several years, and studies stop accepting volunteers or conclude the trials after a period of time. IBS Impact, as an entity, is not directly affiliated with any research sponsor or organization and receives no funding from any source for studies, surveys or links we feature on this blog, the main site or social media.


Representatives Engel of New York and Pocan and Kind of Wisconsin Co-Sponsor HR 2311 for Functional Gastrointestinal and Motility Disorders

July 11, 2016

According to IFFGD/the Digestive Health Alliance and the official Congressional legislative database Congress.gov, Representative Eliot Engel (D-NY-16), Representative Mark Pocan (D-WI-2), and Ron Kind (D-WI-3) have recently signed on as a co-sponsors to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015.

Representative Engel is serving his fifteenth term in the House of Representatives. His current district, the 16th Congressional District of New York  encompasses the northern portion of the Bronx, which is one of the boroughs of New York City, as well as parts of suburban southern Westchester County. Representative Engel is the first co-sponsor who is also a current member of the Subcommittee on Health, where HR 2311 is  under consideration.  See the linked website for a list of all current members. Representative Engel has a long record of supporting  a wide range of veterans’ issues and health issues, as seen on his official house website. As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk for functional gastrointestinal disorders like IBS, which are already very common in the general population.

Representative Pocan is serving his second term in the House of Representatives. His district, the 2nd Congressional District of Wisconsin, encompasses Dane County, Iowa County, Lafayette County, Sauk County and Green County and parts of Richland and Rock Counties, including the state capital of Madison and environs. According to his official House website, Representative Pocan is a member of the House Committee on the Budget, and he supports various health and veterans’ issues.

Representative Kind is serving his tenth term as a member of the House of Representatives. His district, the 3rd Congressional District of Wisconsin, represents the western part of the state, including La Crosse, Eau Claire and Platteville. Representative Kind’s official House website can be found at the link. Representative Kind has a record of supporting veterans’ issues. He is also a former member of the Subcommittee on Health and was also a co-sponsor of HR 2239 in the 112th Congress (2011-2012) and HR 842 in the 113th Congress (2013-2014), previous versions of HR 2311 which did not pass. IBS Impact thanks him for his continuing  support over three successive Congressional terms.

If you are a constituent of Representative Engel, Representative Pocan or Representative Kind,  please take a few minutes to write or call him with your thanks for his support of the functional gastrointestinal and motility disorders community.

In officially supporting HR 2311, Representative Engel, Representative Pocan and Representative Kind  join Representative F. James Sensenbrenner, Jr. (R-WI-5) , who is the initial sponsor,  Representative Andre Carson (D-IN-7), Representative Zoe Lofgren (D-CA-19) and Representative Gwen Moore (D-WI-4), Representative David Young (R-IA-3), Representative David Loebsack (D-IA-2), Representative Keith Rothfus (R-PA-12), and Representative David Joyce (R-OH-14), and Representative Sean Duffy, (R-WI-7) If you are a constituent of any of these Representatives, please thank them as well.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 2311, please see the previous post from May 18, 2015 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 2014 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 2311 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 2311.

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 2311 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 114th,  the necessary number of sponsor/cosponsors must be reached by December 2016. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 2311 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 and HR 842 in 2014. 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 2311 as they occur. Links to the social media sites can be found on the right sidebar of the blog.


Representative Duffy of Wisconsin Co-Sponsors HR 2311 for Functional Gastrointestinal and Motility Disorders

July 5, 2016

According to IFFGD/the Digestive Health Alliance and the official Congressional legislative database Congress.gov, Representative Sean Duffy (R-WI-7) has recently signed on as a co-sponsor to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015.

Representative Duffy is serving his third term in the House of Representatives. His district, the 7th Congressional District of Wisconsin, encompasses the northwestern and central regions of the state, including Ashland, Barron, Bayfield, Burnett, Chippewa, Douglas, Iron, Lincoln, Marathon, Oneida, Polk, Portage, Price, Rusk, Sawyer, Taylor, Washburn and Wood Counties and parts of Clark and Langlade Counties.  According to his official House website, Representative Duffy has a record of supporting veterans’ issues. As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk for functional gastrointestinal disorders like IBS, which are already very common in the general population.

If you are a constituent of Representative Duffy,  please take a few minutes to write or call him with your thanks for his support of the functional gastrointestinal and motility disorders community.

In officially supporting HR 2311, Representative Duffy  joins Representative F. James Sensenbrenner, Jr. (R-WI-5) , who is the initial sponsor,  Representative Andre Carson (D-IN-7), Representative Zoe Lofgren (D-CA-19) and Representative Gwen Moore (D-WI-4), Representative David Young (R-IA-3), Representative David Loebsack (D-IA-2), Representative Keith Rothfus (R-PA-12), and Representative David Joyce (R-OH-14). If you are a constituent of any of these Representatives, please thank them as well.

According to the information on Congress.gov, it appears that the bill is currently under consideration in the Subcommittee on Health. Click on the link above if you would like to see a list of its members.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 2311, please see the previous post from May 18, 2015 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 2014 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 2311 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 2311.

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 2311 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 114th,  the necessary number of sponsor/cosponsors must be reached by December 2016. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 2311 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 and HR 842 in 2014. 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 2311 as they occur. Links to the social media sites can be found on the right sidebar of the blog.


Representative Joyce of Ohio Co-Sponsors HR 2311 for Functional Gastrointestinal and Motility Disorders

June 28, 2016

According to IFFGD/the Digestive Health Alliance and the official Congressional legislative database Congress.gov, Representative Dave Joyce (R-OH-14) has recently signed on as a co-sponsor to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015.

Representative Joyce is serving his second term in the House of Representatives. His district, the 14th Congressional District of Ohio,encompasses the northeastern region of the state bordering Lake Erie and the Pennsylvania, including  Ashtabula, Lake, and Geauga Counties, eastern Cuyahoga County, northern Trumbull County, northern Portage County, and northeastern Summit County. According to his official House website, Representative Joyce is currently a member of the House Subcommittee on Military Construction and Veterans’ Affairs.  As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk for functional gastrointestinal disorders like IBS, which are already very common in the general population. Representative Joyce also is a member of several caucuses supporting other specific health conditions.

If you are a constituent of Representative Joyce,  please take a few minutes to write or call him with your thanks for his support of the functional gastrointestinal and motility disorders community.

In officially supporting HR 2311, Representative Joyce  joins Representative F. James Sensenbrenner, Jr. (R-WI-5) , who is the initial sponsor,  Representative Andre Carson (D-IN-7), Representative Zoe Lofgren (D-CA-19) and Representative Gwen Moore (D-WI-4), Representative David Young (R-IA-3), Representative David Loebsack (D-IA-2), and Representative Keith Rothfus (R-PA-12) If you are a constituent of any of these Representatives, please thank them as well.

According to the information on Congress.gov, it appears that the bill is currently under consideration in the Subcommittee on Health. Click on the link above if you would like to see a list of its members.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 2311, please see the previous post from May 18, 2015 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 2014 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 2311 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 2311.

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 2311 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 114th,  the necessary number of sponsor/cosponsors must be reached by December 2016. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 2311 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 and HR 842 in 2014. 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 2311 as they occur. Links to the social media sites can be found on the right sidebar of the blog.