Tag Archives: FDA

U.S. Food and Drug Administration (FDA) Asks Manufacturers to Limit Quantity of Loperamide (Imodium) in Packages

On January 30, 2018, the U.S. Food and Drug Administration (FDA) which regulates the approval and distribution of medications in the U.S, issued a drug safety warning for the anti-diarrheal medication loperamide.  Loperamide is more commonly recognized by the public by the brand name Imodium, although it is also sold under generic and store brand …

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Alosetron Risk Evaluation and Mitigation Strategies Paid Survey for Women Using Alosetron (Lotronex) Opens January 3, 2018

IBS Impact has received this notice directly from Alosetron Risk Evaluation and Mitigation Strategies Program on behalf of the U.S. FDA, and is posting at the program’s request.  This is paid survey for women who have taken alosetron (Lotronex) for IBS-D anytime in the last 12 months. The exact text provided to IBS Impact follows …

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U.S. Food and Drug Administration Issues Drug Safety Communication for IBS-D Medication Eluxadoline (Viberzi), March 2017

Today, March 15, 2017, IBS Impact learned via IFFGD social media that the U.S. Food and Drug Administration (FDA) issued a drug safety communication for eluxadoline (also known by the brand name Viberzi), currently used in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. This warning applies specifically …

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U.S. Food and Drug Administration Approves Eluxadoline and Rifaximin for IBS with Diarrhea

Earlier this week, on May 27, 2015, the U.S. Food and Drug Administration approved two new medications, eluxadoline (to be known by the brand name Viberzi) and rifaximin (known by the brand name Xifaxan)  for use in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. Both medications have …

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Registration for Food and Drug Administration May 2015 Public Meeting for IBS, GERD, Gastroparesis, Chronic Idiopathic Constipation Patients Now Open

In April 2013, the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, announced that the U.S. Food and Drug  Administration had chosen three functional gastrointestinal and motility disorders to be included in its  “patient focused initiative.” (See the May 1, 2013 blog post.) The FDA is responsible for the …

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U.S. Food and Drug Administration (FDA) Releases Warning About Sodium Phosphate Laxatives

An announcement from IFFGD recently alerted us to the fact that the U.S. Food and Drug Administration (FDA) recently issued expanded warnings regarding over the counter oral or rectal laxatives that contain sodium phosphate, due to increased risks of severe side effects or death in certain groups of users. Currently, labels state to take a …

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U.S. Food and Drug Administration (FDA) Sets Standard for “Gluten-Free” Labeling

On August 2, 2013, the U.S. Food and Drug Administration (FDA) issued a standard definition for the use of the terms “gluten-free”, “free of gluten”, “no gluten” and “without gluten” in voluntary food labeling. Gluten is a type of protein found naturally in wheat, barley, rye and hybrids using these grains. From now on, the …

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Food and Drug Administration Selects IBS, GERD and Gastroparesis for Patient-Focused Initiative

Last week, the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, announced that the U.S. Food and Drug  Administration has chosen three functional gastrointestinal and motility disorders to be included in its  “patient focused initiative.” (See IFFGD/DHA April 2013  FDA news here.) The FDA is responsible for the review, …

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

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 …

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ACTION ALERT: Food and Drug Administration Needs Comments From People With IBS By November 1, 2012

UPDATE: 05/01/2013 : In April 2013, the FDA selected IBS as one of 3 functional gastrointestinal disorders and one of 16 varied disorders in total for the first 3 years of this program. See more information in the May 1, 2013 post. The International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive …

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