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Bedminster, NJ, July 8, 2019 - https://www.alfasigmausa.com/zelnorm/
Alfasigma USA Acquires ZELNORMTM (tegaserod) for Reintroduction to the US Market
Alfasigma USA has acquired the brand ZELNORM (tegaserod), a treatment for IBS-C, from Sloan Pharma
In March 2019, ZELNORM was approved for reintroduction by the FDA for the treatment of adult women less than 65 years of age with IBS-C.
Alfasigma USA plans to relaunch the brand in the United States, making ZELNORM available by prescription in the coming weeks.
Megan Brooks - April 02, 2019
The US Food and Drug Administration (FDA) has approved the reintroduction of tegaserod oral tablets (Zelnorm, Sloan Pharma) for irritable bowel syndrome with constipation (IBS-C) in women younger than age 65, US WorldMeds Holdings has announced.
"We are excited about what the reintroduction of Zelnorm means for patients suffering from irritable bowel syndrome with constipation. We have continually heard from patients and clinicians alike that the IBS-C community is eager to have Zelnorm return to the US a s an available treatment option," P. Breckinridge Jones, CEO of US WorldMeds, said in the news release.
"The re-approval of Zelnorm is very good news for patients. We believe it will provide renewed access to a treatment option where other new medications have been insufficient for meeting patients' needs," added Jeffery Roberts, patient advocate and founder of the IBS Patient Group.
Checkered Past
Tegaserod for IBS-C has had a checkered past. The drug was first approved by the FDA in 2002 for the short-term treatment of women with IBS-C. It was suspended from the US market in March 2007 due to potential cardiovascular (CV) safety concerns.
In July 2007, the FDA announced that it would allow restricted use of the drug for IBS-C and chronic idiopathic constipation in women younger than 55 years with no history of heart problems.
Last October, following a safety review, the FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended overwhelmingly (11 yes, 1 no) to recommend reintroducing tegaserod for IBS-C in women without a history of CV ischemic disease and who have no more than one risk factor for CV disease.
The committee reviewed clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data.
Pooled data from the clinical trials showed a statistically nonsignificant trend toward increased angina among those who took the drug in the clinical trial on which the drug's approval was based in 2002; however, a recent analysis of 18,000 participants in the entire clinical database found adverse CV events in 13 of 11,614 patients (0.11%) taking tegaserod, compared with only one patient (0.01%) out of 7031 in the placebo group, a difference that was statistically significant, according to information in an FDA briefing document for the committee.
"While an imbalance in CV safety events associated with tegaserod was noted, the strength of the signal was difficult to interpret due to limitations of the meta-analysis â€" for example, the trials were not designed to specifically evaluate CV safety, were of short duration, included a low CV-risk population, and involved retrospective assessment of CV information. In addition, the etiology of [CV ischemic] events related to the use of tegaserod is not well understood," the FDA explained in the briefing document.
Tegaserod is the only selective serotonin-4 (5-HT4) receptor agonist approved to treat IBS-C, US WorldMeds notes in the release.
In clinical trials, patients taking tegaserod experienced improvement in some of the most bothersome IBS-C symptoms; in the first 4 weeks, significantly more tegaserod-treated patients than placebo-treated patients reported an improvement in abdominal pain/discomfort and bloating. The frequency of bowel movements also increased from a median number of 3.8 per week at baseline to 6.3 per week at month 1, the company said.
Zelnorm will be available by prescription for patients in the coming months, according to the company.
See Safer Alternatives to Zelnorm
https://www.medscape.com/viewarticle/911237
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
Edited by Heather (08/20/19 03:31 PM)
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Does cannabis make you poo?
Meg Hartley
April 13, 2020
Between cannabis calming our nerves, its effect on the gut’s microbiome, and the endocannabinoid system being involved in the activity in this department, it looks like weed can, indeed, make us poo.
I spoke with medical cannabis expert and integrative medicine physician Dustin Sulak, D.O. “Endocannabinoids absolutely do affect motility, both directly and indirectly. The most powerful way in which cannabis could help a person defecate is by helping them to relax and get into a more parasympathetic state,” said Sulak.
Another way to think of a parasympathetic state is “rest and digest,” with defecation being part of the digest aspect. This is opposed to the sympathetic nervous system, which prepares the body to act quickly. There is an evolutionary reason for not being able to poo while in a fight-or-flight state enacted by the sympathetic nervous system: “If we’re escaping from a bear attacking us, we don’t want to have to defecate,” said Sulak.
He continued, “Conversely, when it’s time to relax and empty our bowels, we don’t want to feel threatened. That has to happen in a place where we feel comfortable. But, unfortunately, a lot of people are taking their stressors around with them, even into the bathroom, with their phones or just in their minds, remaining stressed out, feeling threatened in some way.”
But cannabis, and endocannabinoids that our bodies produce, can help. “Our inner pharmacy’s version of cannabis, the endocannabinoids, and herbal cannabis, have the ability to suppress this excessive sympathetic activity. So if the fight-or-flight response is turned on too strongly, the right dose of cannabis can suppress it. This is obvious to people who use cannabis to help them relax and find relief from anxiety. The same mechanism would allow someone to shift into rest and digest, or parasympathetic dominance, and get the job done,” he said.
The Goldilocks zone
Endocannabinoids help keep the body in balance. One of those endocannabinoids, 2-AG, is an important physiologic regulator of gastrointestinal motilityâ€"i.e., poopingâ€"and behaves like THC. “That’s one of our body’s signaling molecules that mimics THC, or THC mimics it. 2-AG is active in regulating the sympathetic and parasympathetic influence on the gut, and in the gut itself, where it suppresses excessive activity and brings the system into balance,” said Sulak.
So in this way, cannabis could lead to a deuce by helping keep our nervous system and our gut in the “Goldilocks zone,” or the healthy range of activity.
Cannabis can also help someone get into the needed relaxed state by relieving pain. “When people are in chronic pain, even if it has nothing to do with the rectumâ€"if it’s their foot or their leg or their headâ€"that still creates a kind of threatening internal state. So it can be hard when in pain or feeling anxiety to relax enough to use the bathroom. Cannabis can be very useful for that,” said Sulak.
Dr. Sulak concluded with a word of caution: “For people with constipation not related to stress or pain, cannabis could potentially worsen the issue because it can suppress muscular contractions and secretion in the colon, the same ways in which it can help with diarrhea.”
The endocannabinoid system (ECS) is also integral to the brain-gut axis, which modulates activity in this realm, including helping people poop. This 2016 study says that the ECS is “An important physiologic regulator of gastrointestinal motility,” meaning bowel movements.
Foremost psychopharmacology researcher Ethan Russo, M.D., also told us, “A lot of people note easier bowel movements after cannabis. This can alleviate both constipation or diarrhea associated with irritable bowel syndrome, a presumptive clinical endocannabinoid deficiency syndrome. THC also positively alters the gut microbiome and this effect should not be discredited.”
Additionally, a 2019 study found that cannabis consumption was associated with a 30% decrease in constipation.
https://www.leafly.com/news/health/does-marijuana-make-you-poo
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
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For IBS Patients, Cannabis Linked to Fewer Rehospitalizations, Shorter Stays
30-day readmission rate and overall costs were lower in cannabis users
by Diana Swift, Contributing Writer May 5, 2020
Cannabis use may help ease symptoms of irritable bowel syndrome (IBS) that are strong enough to send patients to the hospital, an analysis of the Agency for Healthcare Research and Quality's 2016 Nationwide Readmissions Database suggested.
In their cohort study of hospitalized IBS sufferers, Catherine Choi, MD, of Rutgers New Jersey Medical School in Newark, New Jersey, and colleagues found that all-cause 30-day readmission rates were 12.7% in non-cannabis users and 8.1% in cannabis users. After adjustment for age, sex, median income by zip code, insurance status, Charlson Comorbidity Index, hospital bed size, teaching status, and location, the adjusted odds ratio in cannabis users was 0.53 (95% CI 0.28-0.99).
The study was presented in an online press program organized by Digestive Disease Week, which was to have started on May 2 but was cancelled because of the COVID-19 pandemic.
In addition, cannabis use appeared to correlate with shorter hospital stays, for an adjusted mean difference of -0.44 days (95% CI -0.85 to -0.03, P=0.036), as well as with lower total hospitalization charges, for an adjusted mean difference of -$3,473 (95% CI -$46,773 to -$174, P=0.04). Cannabis use was also associated with a slightly higher survival rate compared with non-use.
The researchers identified 6,798 adult patients with IBS of whom 357 were cannabis users. The inclusion criterion was a principal diagnosis of IBS using ICD-10 CM codes, the exposure of interest was cannabis, and the primary outcome was 30-day readmission to hospital. For patients with and without cannabis use, the mean age differed substantially at 36.7 (range 34.5-38.9) years and 53.3 (52.6-54.1) years, respectively. Women accounted for 62% and 81% of the two groups, respectively.
The most common three reasons for readmission in non-users were enterocolitis due to Clostridium difficile, IBS without diarrhea, and sepsis. In users, the indications for rehospitalization were cyclical vomiting, IBS-diarrhea, and endometriosis. Among non-users, independent factors predicting readmission were mean age (0.99, 95% CI 0.98-1.33, P=0.04), having private insurance (0.56, 95% CI 0.41-0.77, P<0.01), and home healthcare (1.98, 95% CI 1.40-2.82, P<0.01). None of the factors analyzed predicted readmission in cannabis users, the researchers noted.
Adding medical marijuana to standard analgesics is under discussion for easing pain or increasing pain tolerance in such conditions as fibromyalgia-related back pain.
Asked for his perspective, Anthony J. Lembo, MD, of Beth Israel Deaconess Medical Center in Boston, who was not involved with the research, noted that to date no studies have evaluated the effect of cannabis on IBS symptoms. "While the authors hypothesize that cannabis use is associated with better control of irritable IBS compared to no cannabis use, the current study does not provide information to support or disprove this hypothesis," he told MedPage Today.
Lembo pointed out that cannabis users in the study who were hospitalized with a principal diagnosis of IBS were significantly different from those who did not use cannabis: "Specifically, they differed in age and sex, both of which are likely to contribute to reasons for readmissions," he said. "And cyclic vomiting was one of the most common reasons for readmission in the cannabis group, which is a known complication of cannabis use."
He said that such intergroup differences and the small number of cannabis users in the study preclude drawing conclusions about factors affecting survival, adding: "And it's worth noting that use of ICD-10 codes likely under-represents the true number of patients with these disorders. I don't think there is more you can interpret from these data."
Disclosures
One study co-author reported relationships with Allergan, Bayer, BeiGene, Bristol-Myers Squibb, Confirm, Conatus, Intercept, Mallinckrodt, Novartis, Resusix, Saro, Valeant, Gilead, Exelixis, Hologic, Shire, Genfit, and Prometheus outside of the submitted work. All other authors reported no conflicts of interest.
Lembo reported having no conflicts of interest in regard to his comments.
Primary Source
Digestive Disease Week
Source Reference: Choi CJ, et al "Cannabis use is associated with reduced 30-day readmission among hospitalized patients with irritable bowel syndrome: a nationwide analysis" DDW 2020; Abstract #Mo1560.
https://www.medpagetoday.com/meetingcoverage/ddw/86306
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
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Growing evidence suggests popping too many heartburn pills is actually CAUSING tummy troubles
Proton pump inhibitors could trigger debilitating gut symptoms, experts claim
Over-reliance on the drugs could even explain a recent surge in IBS diagnoses
Heartburn is caused when vital stomach acid travels up towards the throat
By Eve Simmons For The Mail On Sunday
Published: 17:01 EST, 5 December 2020 ' Updated: 17:01 EST, 5 December 2020
Tis the season for indigestion, with the festivities leaving many reaching for heartburn tablets.
The pills, which stop the burn caused by stomach acid travelling up into the back of the throat after a meal, are among the top ten most frequently prescribed in the world, with two million Britons relying on them almost daily.
But a growing body of evidence suggests that the most popular type of heartburn medication, known as proton pump inhibitors (PPIs), could in fact trigger a whole host of debilitating gut symptoms.
In fact, experts warn that the over-reliance on PPI drugs such as omeprazole and lansoprazole could even explain a recent surge in diagnoses of irritable bowel syndrome (IBS).
'It's a Catch-22 situation because these drugs work well to control the initial symptoms, but the long-term effects can be detrimental,' says Dr Rehan Haidry, consultant gastroenterologist at University College Hospital, London.
'Two in three patients I see with heartburn have been taking these for years and go on to develop flatulence, bloating and bowel problems. It's no coincidence.'
Heartburn, or indigestion, is caused when stomach acid, which is vital for breaking down food, travels up towards the throat.
The most common trigger is overeating, which puts extra pressure on the muscular barrier between the stomach and food pipe, making it prone to leaks.
Diets high in acidic foods and drinks â€" caffeine, red wine and chocolate, for example â€" exacerbate the problem, which is also termed acid reflux.
Drugs, available both from the GP and over the counter, combat this by limiting the amount of acid produced in the stomach cells by blocking chemicals involved in its production â€" and are highly effective.
But a recent study involving 300,000 patients found that taking PPIs for months on end was linked with a 65 per cent increased risk of developing embarrassing tummy upsets â€" most commonly, diarrhoea.
The research adds to a growing body of evidence pointing in the same direction. The problem lies with the reduction of acid in the stomach and bowel. 'We need some acid in the small bowel to kill off bacteria,' says Dr Haidry.
'Prolonged PPI use means less acid, but also makes the small bowel more welcoming to bacteria, allowing it to grow rather than move through the digestive system.'
While gut bacteria are beneficial, too much causes problems.
'Bacteria feed on sugars in foods we eat, causing a fermentation process. This results in the release of hydrogen and methane gas, causing bloating and cramps and other symptoms,' adds Dr Haidry.
The condition, called small intestinal bacterial overgrowth, or SIBO, is up to seven times more common in frequent PPI takers, according to a 2013 analysis by Harvard Medical School. Most frustratingly, it is known to make acid reflux far worse.
There is a breath test that measures the amount of hydrogen gas produced shortly after eating, but it is not widely available on the NHS and studies show it can miss the problem in up to a third of patients.
Many are instead given a diagnosis of irritable bowel syndrome â€" a catch-all term which, according to Dr Haidry, denies targeted, effective treatment.
'Really we need a combination of hydrogen breath test and a sample of bacteria taken from the small bowel for diagnosis,' he adds. 'But often the diagnosis is clear when patients tell me their history of PPI use and the onset of symptoms.
'We can give antibiotics to destroy bacteria in the small bowel, while avoiding foods high in fermentable sugars, such as beans, fruit and root vegetables, can cut the amount of gas produced.'
Despite the growing body of evidence supporting the link between PPIs and gut issues, it remains controversial â€" not all doctors support Dr Haidry's theory. But it's certainly the case that patients are not getting timely treatment.
Alex Rainer, a 29-year-old logistics manager from Hertfordshire, is one such case. She has been taking a PPI daily for nine years â€" a mixture of prescription and over-the-counter tablets â€" to treat heartburn. But at the beginning of the year she noticed a strange sensation in her abdomen.
Now, every few weeks she'll spend the best part of 48 hours rushing back and forth to the toilet. 'I get a weird 'watery' feeling, like something is bubbling in there,' she says.
'It's very painful and grumbly. Sometimes I'll feel a big grumble, then have to run to the loo. But 85 per cent of the time the drug stops my reflux, so I just put up with it.'
With such effective drugs, many like Alex are reluctant to give them up, and what's the alternative?
'It is very important to stop the flow of acid, as prolonged reflux can increase the risk of throat and gullet cancers,' says Dr Haidry.
'But this can be done through some short-term PPI treatment and lifestyle interventions, like not eating too late, reducing smoking and cutting down on trigger foods.'
Other over-the-counter medications, such as Gaviscon, that work to neutralise acid rather than stop its production, can also help, as can simply going for a short walk after meals. Surgery to 'tighten' the opening between stomach and gullet may sometimes help too.
'But it's essential that the root cause of the problem is identified first â€" often it's nothing to do with acid,' Dr Haidry adds.
'To send people off with pills for ever is simply not good enough.'
https://www.dailymail.co.uk/health/article-9021285/Growing-evidence-suggests-popping-heartburn-pills-actually-CAUSING-tummy-troubles.html
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
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A recent survey conducted by Care by Design, a California-based medical marijuana company, found that 100 percent of participants who utilized medical marijuana for migraines, fibromyalgia, irritable bowel syndrome (IBS), and spinal cord injury reported reduced pain and discomfort.
The survey included 621 medical marijuana patients over a period of 30 days, and inquired about a wide variety of health issues. The health issues the patients utilized medical marijuana for included anxiety, depression, posttraumatic stress disorder (PTSD), autism, addiction, arthritis, rheumatism, epilepsy, neuropathic pain, migraine headaches, central nervous system disorders, and cancer-associated symptoms, among others.
The report findings are listed below:
88.2% of patients reported that cannabis therapy improved their overall sense of well-being.
72.6% of all patients reported a decrease in pain or discomfort.
All patients (100%) with headaches and migraines, fibromyalgia, irritable bowel syndrome (IBS), and spinal cord injury reported a decrease in pain or discomfort.
64.2% of all patients reported an improvement in mood.
100% of patients with PTSD and spinal cord injuries reported an improvement in mood.
Patients with fibromyalgia, headaches and migraines, PTSD and anxiety reported the greatest improvement in general well-being (as compared to other patient groups).
Medical marijuana has been widely researched in recent decades, as its use becomes more commonplace in America and around the world to treat various health conditions. The 2015 report by Care by Design has not been approved by the U.S. Food and Drug Administration (FDA), however, the findings are significant.
The use of medical marijuana has been found to improve health and well-being for patients suffering from chronic diseases. State laws have been shifting in favor of medical marijuana use, with a few select states, like Oregon, Colorado and Washington, voting in favor of the recreational use of marijuana, as well.
Approximately 80 percent of prescription pain pill use takes place solely in the United States, and every 19 minutes someone overdoses and dies from prescription pain pill use, Dr. Sanjay Gupta, CNN chief medical correspondent, told Marlo Thomas of The Huffington Post in an interview. Marijuana could possibly be a safer alternative to prescription drugs for the pain and discomfort associated with a myriad of health problems.
â€"Stephen Seifert
Sources:
http://blog.sfgate.com/smellthetruth/files/2015/09/CBD-Patient-Survey-September2015.pdf
https://www.cbd.org
http://www.huffingtonpost.com/2015/06/22/marijuana-versus-prescrip_n_7638988.html
https://www.thealternativedaily.com/medical-marijuana-for-migraines-fibromyalgia-ibs/
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
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