Help
Subscribe


GastroHep.com - the global online resource for all aspects of gastroenterology, hepatology and endoscopy

 28 May 2018

Advanced search
GastroHep.com - the global online resource for all aspects of gastroenterology, hepatology and endoscopy Profile of Roy Pounder

Home

News  
Journals
Review Articles
Slide Atlas
Video Clips
Online Books
Advanced Digestive Endoscopy
Classical Cases
Conference Diary
PubMed
International GH Links
USA GH Links
National GH Links
National GI Societies
Other Useful Links




Emails on Gastroenterology and Hepatology
the National AIDS Treatment Advocacy Project
Visit the gastroenterology section of the EUMS

News

FDA allows alosetron back on the market

The Food and Drug Administration (FDA) has announced the approval of a supplemental New Drug Application (sNDA) that permits marketing of alosetron hydrochloride with restrictions.

News image

fiogf49gjkf04

The drug's indication has been narrowed to be only for treatment of women with severe, diarrhea-predominant Irritable Bowel Syndrome (IBS), who have failed to respond to conventional IBS therapy.

Less than 5% of IBS is considered severe, and only a fraction of severe cases are diarrhea-predominant IBS.

Limiting the use of alosetron (Lotronex) to this severely affected population is intended to maximize the benefit to risk ratio.

The marketing of alosetron is being restricted because serious and unpredictable gastrointestinal adverse events, including some that resulted in death, were reported in association with its use when it was previously marketed.

The approved sNDA for alosetron includes a risk management program that the drug's manufacturer, GlaxoSmithKline (GSK), will implement.

Alosetron approved for women with severe, diarrhea-predominant IBS.
FDA

"All drugs have risks. It's FDA's job to balance the need for access to effective medications with those risks," said Dr Lester M. Crawford, FDA Deputy Commissioner.

"Informed decision-making by physicians and patients is critically important in managing the risks of marketed medications. Everyone needs to take an active role," added Dr Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research.

The action follows a recommendation on 23 April 2002, by FDA's Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science, to restore access to alosetron through a restricted distribution and use program.

As of 8 March 2002, there had been 84 cases of ischemic colitis and 113 cases of serious complications of constipation reported to FDA through its Adverse Event Reporting System.

The 84 cases of ischemic colitis resulted in 54 patients requiring hospitalization, 2 receiving blood transfusions, 11 requiring surgery, and 2 deaths.

The 113 cases of serious complications of constipation resulted in 83 patients requiring hospitalization, 34 undergoing surgery, 2 receiving blood transfusions, and 2 deaths.

FDA first approved alosetron in February 2000.

GlaxoSmithKline voluntarily withdrew the drug from the market in November 2000, due to post-marketing reports of complications and deaths.

FDA
11 June 2002

Go to top of page Email this page Email this page to a colleague

 28 May 2018 
Therapeutic strategies for HCV
 28 May 2018 
Mesalazine in ulcerative colitis
 28 May 2018 
Technology and management of digestive diseases
 25 May 2018 
Technology to increase colorectal cancer screening
 25 May 2018 
Post‐operative complications in elderly IBD
 25 May 2018 
Colorectal cancer–specific mortality
 24 May 2018 
Alcohol consumption and outcomes in drug-induced liver injury
 24 May 2018 
Patient-reported outcome measures in IBD trials
 24 May 2018 
Precision medicine for tumors
 23 May 2018 
Management of perianal fistulas in Crohn’s disease
 23 May 2018 
Cardiovascular risk in diabetes mellitus with NAFLD
 23 May 2018 
High body mass index is and ulcerative colitis
 22 May 2018 
Worldwide H.pylori prevalence
 22 May 2018 
PPI and risk of stroke
 22 May 2018 
Online tool predicts bowel dysfunction severity prior to anterior resection
 21 May 2018 
PPI use and cognitive decline
 21 May 2018 
Depressive symptoms in IBD youth
 21 May 2018 
Fecal incontinence and quality of life in IBD
 18 May 2018 
Esophageal dilatation in clinical practice 
 17 May 2018 
IBD and later extraintestinal manifestations
 17 May 2018 
Repeat stool DNA testing
 17 May 2018 
IBS and chronic fatigue following GI infection
 16 May 2018 
Factors associated with fecal incontinence
 16 May 2018 
Diagnostic delay in Crohn's disease
 16 May 2018 
Cardiovascular risk in diabetes mellitus with NAFLD
 15 May 2018 
Guidelines for management of Crohn's
 15 May 2018 
New therapies for CDI
 15 May 2018 
Hep B in the Grey Zone
 14 May 2018 
Blood test for the diagnosis of fibrotic NASH
 14 May 2018 
Outcomes at bariatric centers of excellence
 14 May 2018 
Management of perianal fistulas in Crohn’s
 11 May 2018 
Detection of undiagnosed celiac disease
 11 May 2018 
Alcohol consumption and drug-induced liver injury
 10 May 2018 
Colorectal cancer screening
 10 May 2018 
Fibrosis in patients with chronic hepatitis B
 09 May 2018 
Fecal incontinence
 09 May 2018 
Health problems and IBS
 09 May 2018 
Esophageal dilatation in clinical practice 
 07 May 2018 
Omitting antibiotics in uncomplicated acute diverticulitis
 07 May 2018 
Health problems and IBS
 07 May 2018 
Assessment of diminutive colorectal polyps
 04 May 2018 
National Institutes of Health workshop and obesity
 04 May 2018 
Factors associated with fecal incontinence
 04 May 2018 
Colorectal cancer screening and ethnic inequities
 03 May 2018 
Gastrointestinal ultrasound in IBD
 03 May 2018 
Ultransonography in postsurgical recurrence in Crohn's
 02 May 2018 
Symptom assessment in cirrhotic ascites
 02 May 2018 
Hep C antiviral treatment and liver cancer risk
 02 May 2018 
Chronic Hep B
 01 May 2018 
European guidelines on pancreatic cystic neoplasms
 01 May 2018 
Interferon‐free regimens in Hep C
 01 May 2018 
Age at IBD onset and extraintestinal complications
 30 April 2018 
Formula for preterm infants
 30 April 2018 
Primary antibiotic resistance and sequential therapy for H. pylori
 27 April 2018 
Eastern and western practices for endoscopic resection of colorectal lesions
 27 April 2018 
Anxiety scale for chronic esophageal disease
 27 April 2018 
Disease activity in eosinophilic esophagitis
 26 April 2018 
Obesity and physical activity in diverticulosis
 26 April 2018 
Primary sclerosing cholangitis in the USA
 25 April 2018 
Aspirin and pancreatic cancer

Blackwell Publishing


GastroHep.com is a Blackwell Publishing registered trademark
© 2018 Wiley-Blackwell and GastroHep.com and contributors
Privacy Statement
Disclaimer
About Us