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Irritable Bowel Syndrome News

Related terms: IBS, Spastic colon

FDA Medwatch Alert: Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Posted 12 days ago by

ISSUE: FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns. See the FDA Drug Safety Communication for a Data Summary. BACKGROUND: Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Viberzi works by decreasing ... Read more

Related support groups: Irritable Bowel Syndrome, Pancreatitis, Viberzi, Eluxadoline

Health Tip: Coping With Irritable Bowel Disease Flares

Posted 30 Dec 2016 by

-- Watching what you eat won't completely prevent irritable bowel flares, but it can help significantly. The Crohn's and Colitis Foundation of America suggests: Opting for smaller, more frequent meals. Limiting fried, greasy foods. Restricting dairy products. Cutting back on high-fiber foods, such as nuts, popcorn, seeds and corn. Read more

Related support groups: Irritable Bowel Syndrome

FDA Medwatch Alert: Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

Posted 16 Sep 2016 by

ISSUE: Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico. See the press release for a listing of affected batch numbers. Taking a product that is superpotent could result in hot/dry skin, fever, blurred vision, sensitivity to light, dry mouth, unusual excitement, fast or irregular heartbeat, dizziness, an inability to completely empty the bladder, and seizures. The severity of the adverse event would depend on how superpotent the tablet was. Adverse events such as clotted blood within the tissues and fractures could ... Read more

Related support groups: Irritable Bowel Syndrome, Urinary Incontinence, Hyoscyamine, Levsin, Symax Duotab, Levsin SL, Hyosyne, HyoMax, Levbid, Symax SL, NuLev, Symax FasTabs, Symax FasTab, HyoMax SL, Anaspaz, HyoMax SR, Levsinex SR, Levsinex, Hyosol, Cystospaz-M

Do Genes Link Headaches, Irritable Bowel Syndrome?

Posted 23 Feb 2016 by

TUESDAY, Feb. 23, 2016 – Genetic links may exist between irritable bowel syndrome (IBS) and migraine and tension-type headaches, researchers report. "Since headache and irritable bowel syndrome are such common conditions, and causes for both are unknown, discovering a possible link that could shed light on shared genetics of the conditions is encouraging," study author Dr. Derya Uluduz said in a news release from the American Academy of Neurology. The findings might help point to new treatments for all of the disorders, suggested Uluduz, of Istanbul University in Turkey, and colleagues. The study included 107 people with migraine, 53 with tension-type headache, 107 with IBS and 53 without any of the conditions. People with migraine were about twice as likely as those with tension headache to also have IBS – 54 percent versus 28 percent, respectively. Of the people with IBS, 38 also ... Read more

Related support groups: Headache, Migraine, Irritable Bowel Syndrome, Migraine Prevention, Cluster Headaches, Migraine Prophylaxis, New Daily Persistent Headache

New IBS Drug Eases Stomach Pain and Diarrhea for Some: Study

Posted 21 Jan 2016 by

WEDNESDAY, Jan. 20, 2016 – A new drug for irritable bowel syndrome with diarrhea seems to reduce symptoms for some patients for at least six months, two clinical trials found. Based on these findings, the drug Viberzi (eluxadoline) was approved recently by the U.S. Food and Drug Administration. In the phase 3 trials, more than 30 percent of patients experienced improvement in their symptoms at least half of the time they were taking the drug. This compared to about a 20 percent improvement in those taking a placebo, the study authors said. "This drug offers another option for patients who have IBS (irritable bowel syndrome) with diarrhea who have not found relief with currently available treatment," said lead researcher Dr. Anthony Lembo, an associate professor of medicine at Harvard Medical School in Boston. This drug, taken twice daily, should only be used for IBS with diarrhea as ... Read more

Related support groups: Diarrhea, Irritable Bowel Syndrome, Diarrhea, Chronic, Viberzi, Eluxadoline

Health Tip: Get Enough Nutrients

Posted 14 Jan 2016 by

-- A nutritious diet is especially important for people with irritable bowel disease (IBD), since they may be at increased risk of malnutrition. The Crohn's and Colitis Foundation of America says possible benefits of a nutritious diet include: Fewer symptoms of IBD. Reduced risk of iron or calcium deficiency. Improved bone health. Healthier body weight. Better regulation of hormone levels in girls and women. Read more

Related support groups: Irritable Bowel Syndrome, Crohn's Disease, Crohn's Disease - Maintenance, Crohn's Disease - Acute

Psych Therapies May Have Long-Term Benefits for Irritable Bowel Patients

Posted 7 Jan 2016 by

WEDNESDAY, Jan. 6, 2016 – Doctors have long known that psychological therapies such as relaxation and hypnosis can temporarily ease the symptoms of irritable bowel syndrome (IBS). But, new research suggests they could also offer long-term benefits. IBS is a gastrointestinal disorder that affects up to 16 percent of the U.S. population. It causes chronic abdominal pain, discomfort, bloating, diarrhea or constipation. There's currently no cure, but dietary changes, medication and psychological interventions can provide symptom relief, the study authors noted. "Our study is the first one that has looked at long-term effects," said the study's senior author, Lynn Walker, a professor of pediatrics at Vanderbilt University Medical Center, in Nashville. "We found that the moderate benefit that psychological therapies confer in the short term continue over the long term. This is significant ... Read more

Related support groups: Irritable Bowel Syndrome

Diabetes Drug Improves Gut Bacteria, Study Finds

Posted 4 Dec 2015 by

FRIDAY, Dec. 4, 2015 – The diabetes drug metformin appears to trigger favorable changes in intestinal bacteria, a new study finds. Researchers analyzed the intestinal bacteria populations in 784 people with and without type 2 diabetes who lived in China, Denmark and Sweden. The results showed that taking metformin had positive effects on the intestinal bacteria of people with type 2 diabetes. Specifically, the drug improved the ability of the bacteria to produce certain types of short-chain fatty acids that reduce blood sugar levels in different ways. The researchers also found that patients who take metformin have more coliform bacteria in their intestines, which may explain why the drug causes side effects such as bloating and increased flatulence. "We weren't able to show that other types of antidiabetic drugs had any actual impact on the gut microbiota. When studying type 2 ... Read more

Related support groups: Diabetes, Type 2, Metformin, Irritable Bowel Syndrome, Glucophage, Insulin Resistance, Janumet, Acidophilus, Glucophage XR, Florastor, ActoPlus Met, Glumetza, Janumet XR, Glyburide/Metformin, VSL#3, Avandamet, Jentadueto, Lactobacillus Acidophilus, Glucovance, Metformin/Pioglitazone, Flora-Q

Review Finds Fecal Transplants Work Well But Need Tight Regulation

Posted 21 Oct 2015 by

WEDNESDAY, Oct. 21, 2015 – The growing use of fecal transplants needs to be carefully controlled, experts say. The therapy is increasingly being used to treat people with life-threatening intestinal infections, such as those caused by the bacterium Clostridium difficile. The procedure involves transferring fecal matter from a healthy donor into the intestine of a patient so that healthy bacteria can re-colonize the bowel. Researchers analyzed available evidence and found that fecal transplants were 85 percent successful in treating patients, compared with 20 percent for standard antibiotic treatment. A recent clinical trial was halted early because fecal transplantation proved so effective, with a 90 percent success rate compared to 26 percent for powerful antibiotics, the researchers noted. After more than 7,000 fecal transplants, few harmful effects have been reported and the ... Read more

Related support groups: Obesity, Diabetes, Type 2, Irritable Bowel Syndrome, Colitis, Clostridial Infection, Pseudomembranous Colitis

Cutting Certain Carbs Might Not Ease Irritable Bowel Syndrome

Posted 7 Aug 2015 by

FRIDAY, Aug. 7, 2015 – There's little evidence that eliminating certain types of carbohydrates from their diet will benefit people with irritable bowel syndrome (IBS), a new study finds. The researchers looked at the published studies on a specific diet called the low FODMAP diet. This diet is based on the theory that certain carbohydrates are poorly absorbed by the small intestine and that IBS symptoms worsen when people with the disorder eat these types of carbohydrates. The types of carbohydrates eliminated in this diet are found in wheat, onions, legumes, milk, honey, apples, high-fructose corn syrup, and the artificial sweeteners sorbitol and mannitol. Some guidelines suggest that a low FODMAP diet might be appropriate for IBS patients who have had no success with other treatments. But this should only be done under the supervision of a dietitian who specializes in this type of ... Read more

Related support groups: Irritable Bowel Syndrome, Dietary Supplementation, Dietary Fiber Supplementation

Two Drugs Approved for Irritable Bowel

Posted 1 Jun 2015 by

THURSDAY, May 28, 2015 – Two new therapies to treat irritable bowel syndrome accompanied by diarrhea (IBS-D) in adults have been approved by the U.S. Food and Drug Administration. IBS, characterized by loose stools and abdominal discomfort, affects 10 percent to 15 percent of U.S. adults, the FDA said in a news release. The first drug, Viberzi, is taken twice daily with food. It stimulates nervous system receptors that can reduce bowel contractions. Common side effects include constipation, nausea and abdominal pain. The most serious adverse reaction is a type of muscular spasm that can lead to pancreatitis, the FDA said. The second drug, Xifaxan, is taken orally three times daily for 14 days. And people with recurring symptoms can take a second 14-day dose if needed, the agency said. It was approved previously as an antibiotic to treat certain cases of "traveler's diarrhea." It's also ... Read more

Related support groups: Irritable Bowel Syndrome, Xifaxan, Rifaximin, Viberzi, Eluxadoline

FDA Approves New Drugs for Irritable Bowel Syndrome

Posted 1 Jun 2015 by

THURSDAY, May 28, 2015 – Two new drugs for adults with irritable bowel syndrome with diarrhea (IBS-D) were approved by the U.S. Food and Drug Administration on Wednesday. "For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder," Dr. Julie Beitz, director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research, said in an agency news release. "The approval of two new therapies underscores the FDA's commitment to providing additional treatment options for IBS patients and their doctors," she added. Viberzi (eluxadoline) is a pill that contains a new type of active ingredient, and it is taken twice a day with food. It is designed to activate receptors in the nervous system that can lessen bowel contractions. Xifaxan (rifaximin) is a pill taken three times a day for 14 days to ... Read more

Related support groups: Irritable Bowel Syndrome, Xifaxan, Rifaximin, Viberzi, Eluxadoline

FDA Approves Two Therapies to Treat Irritable Bowel Syndrome with Diarrhea (IBS-D)

Posted 28 May 2015 by

May 27, 2015 – The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time. “For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evalu ... Read more

Related support groups: Irritable Bowel Syndrome, Xifaxan, Rifaximin, Viberzi, Eluxadoline

FDA Approves Xifaxan (rifaximin) for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea)

Posted 27 May 2015 by

LAVAL, Quebec, May 27, 2015 /PRNewswire/ – Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills. "As a gastroenterologist who helps patients navigate the symptoms of IBS-D, I see the need for treatments that directly address those most bothersome, such as diarrhea and abdominal pain" said Dr. Mark ... Read more

Related support groups: Irritable Bowel Syndrome, Xifaxan, Rifaximin

FDA Approves Viberzi (eluxadoline) for Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults

Posted 27 May 2015 by

DUBLIN, May 27, 2015 /PRNewswire/ – Actavis plc (NYSE: ACT) announced today that Viberzi (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist. "The FDA's approval of Viberzi is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D," said David Nicholson, Executive Vice President, Actavis Global Brands R&D. "At Actavis, we are dedicated to providing new treatment options, and the development of new agents that help address the most bothersome symptoms of IBS-D. We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly ... Read more

Related support groups: Irritable Bowel Syndrome, Viberzi, Eluxadoline

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