By the Numbers

7 stories you may have missed in September

Healio Gastroenterology and Liver Disease has compiled a list of some of the top stories we reported in September.

Our readers were most interested in the evolving developments in the Zantac recalls, as well as updated Barrett’s esophagus guidelines.

Sandoz halts Zantac distribution

Zantac manufacturer Sandoz recently stopped the distribution of its heartburn medication across all available markets, including the United States and Canada.

The halt in distribution came days after the FDA announced that it had found low levels of N-nitrosodimethylamine (NDMA), a possible human carcinogen, in the medication. READ MORE.

Generic forms of Zantac voluntarily recalled

Sandoz has voluntarily recalled all generic forms of Zantac (ranitidine) in the United States after noting confirmed contamination with NDMA above established FDA levels, according to a company press release.

Sandoz noted that it has not received reports of any adverse events related to use of the medications as part of the recall. READ MORE.

How three GIs are handling the Zantac recall

A week after halting the distribution of Zantac, Sandoz, the drug’s manufacturer, voluntarily recalled several formulations of the heartburn medication after noting confirmed contamination with NDMA above established FDA levels.

To gauge how gastroenterologists have been approaching the evolving landscape with this medication, we reached out to several physicians about the initial distribution halt and subsequent voluntary recall. To read the Q&A, CLICK HERE.

ASGE releases updated screening, surveillance guidelines for BE

ASGE has released updated guidelines for the screening and surveillance of Barrett’s esophagus.

With the goal of improving morbidity and mortality related to esophageal adenocarcinoma (EAC), ASGE’s latest standards address clinical questions including the impact and role of screening and surveillance as well as the utility of sampling modalities and advanced imaging like volumetric laser endomicroscopy (VLE), chromoendoscopy, confocal laser endomicroscopy, wide-area transepithelial sampling and endoscopic ultrasound (EUS). READ MORE.

Stem Cell Therapy: Preparing for its Closeup in IBD

Research into the use of cell-based therapies as possible treatment options for various diseases exploded over the last several years.

One of the most recent noteworthy examples has been the use of chimeric antigen receptor T-cells to treat various oncologic diseases.

But not every disease state is as ready for its closeup regarding the use of cell-based therapies.

We spoke with several surgeons and gastroenterologists about the potential validity and effectiveness cell-based therapies may have in treating gastrointestinal disorders, most notably inflammatory bowel disease. To read the full cover story, CLICK HERE.

EC approves expanded use of Stelara for moderately to severely active ulcerative colitis

The European Commission in September approved the expanded use of Stelara for adults with moderately to severely active ulcerative colitis, according to a company press release.

The expanded use, according to the release, is for patients who have had an inadequate response with, lost response to, or were intolerant to either conventional or biologic therapies, or have medical contraindications to those therapies. READ MORE.

FDA approves Ibsrela for IBS-C in adults

The FDA in September approved Ibsrela, a 50 mg, twice-daily oral therapy for irritable bowel syndrome with constipation in adults.

“Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States,” Mike Raab, president and CEO of Ardelyx, said in a company-issued press release. READ MORE.

Healio Gastroenterology and Liver Disease has compiled a list of some of the top stories we reported in September.

Our readers were most interested in the evolving developments in the Zantac recalls, as well as updated Barrett’s esophagus guidelines.

Sandoz halts Zantac distribution

Zantac manufacturer Sandoz recently stopped the distribution of its heartburn medication across all available markets, including the United States and Canada.

The halt in distribution came days after the FDA announced that it had found low levels of N-nitrosodimethylamine (NDMA), a possible human carcinogen, in the medication. READ MORE.

Generic forms of Zantac voluntarily recalled

Sandoz has voluntarily recalled all generic forms of Zantac (ranitidine) in the United States after noting confirmed contamination with NDMA above established FDA levels, according to a company press release.

Sandoz noted that it has not received reports of any adverse events related to use of the medications as part of the recall. READ MORE.

How three GIs are handling the Zantac recall

A week after halting the distribution of Zantac, Sandoz, the drug’s manufacturer, voluntarily recalled several formulations of the heartburn medication after noting confirmed contamination with NDMA above established FDA levels.

To gauge how gastroenterologists have been approaching the evolving landscape with this medication, we reached out to several physicians about the initial distribution halt and subsequent voluntary recall. To read the Q&A, CLICK HERE.

ASGE releases updated screening, surveillance guidelines for BE

ASGE has released updated guidelines for the screening and surveillance of Barrett’s esophagus.

With the goal of improving morbidity and mortality related to esophageal adenocarcinoma (EAC), ASGE’s latest standards address clinical questions including the impact and role of screening and surveillance as well as the utility of sampling modalities and advanced imaging like volumetric laser endomicroscopy (VLE), chromoendoscopy, confocal laser endomicroscopy, wide-area transepithelial sampling and endoscopic ultrasound (EUS). READ MORE.

Stem Cell Therapy: Preparing for its Closeup in IBD

Research into the use of cell-based therapies as possible treatment options for various diseases exploded over the last several years.

One of the most recent noteworthy examples has been the use of chimeric antigen receptor T-cells to treat various oncologic diseases.

But not every disease state is as ready for its closeup regarding the use of cell-based therapies.

We spoke with several surgeons and gastroenterologists about the potential validity and effectiveness cell-based therapies may have in treating gastrointestinal disorders, most notably inflammatory bowel disease. To read the full cover story, CLICK HERE.

EC approves expanded use of Stelara for moderately to severely active ulcerative colitis

The European Commission in September approved the expanded use of Stelara for adults with moderately to severely active ulcerative colitis, according to a company press release.

The expanded use, according to the release, is for patients who have had an inadequate response with, lost response to, or were intolerant to either conventional or biologic therapies, or have medical contraindications to those therapies. READ MORE.

FDA approves Ibsrela for IBS-C in adults

The FDA in September approved Ibsrela, a 50 mg, twice-daily oral therapy for irritable bowel syndrome with constipation in adults.

“Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States,” Mike Raab, president and CEO of Ardelyx, said in a company-issued press release. READ MORE.

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