Help
Subscribe


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

 20 November 2017

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

Glaxo Wellcome withdraws Lotronex from the US market

Glaxo Wellcome plc has announced that, at the request of the US Food and Drug Administration (FDA) it will voluntarily withdraw Lotronex (alosetron), its treatment for irritable bowel syndrome (IBS), from the US market with immediate effect.

News image

fiogf49gjkf04

This withdrawal has been taken after in-depth discussions with the FDA about the interpretation of data relating to gastrointestinal side-effects which have occurred amongst patients treated with the product. These have included rare reports of fatalities, although no causal relationship with Lotronex has been established.

Glaxo Wellcome is withdrawing all regulatory submissions for alosetron.

During its discussions with the FDA, Glaxo Wellcome had proposed a range of initiatives to educate physicians and patients about the management of the potential side-effects and benefits of Lotronex, including further label modifications and patient education programmes. The FDA has indicated that it does not believe these proposals to be adequate, and has requested that voluntary withdrawal of Lotronex from the US market. Although the company disagrees with the FDA's assessment of the safety profile of the product, Glaxo Wellcome will comply with that request immediately.

"We greatly regret this outcome and believe that Lotronex is effective, that its side-effects are manageable, and that the benefits of the product when treating IBS outweigh the risks," said Dr James Palmer, Senior Vice President and Director Group Medical, Regulatory and Product Strategy, Glaxo Wellcome plc. "Thousands of women who have benefited from Lotronex will have to resort to therapies which did not adequately treat their symptoms in the past."

Lotronex received FDA approval for marketing in the US on 9 February 2000 for the treatment of women with diarrhoea-predominant IBS. It is the first medicine proven in well-controlled large clinical trials to address the multiple symptoms of the condition. Approximately 500,000 prescriptions have been written since the drug became available in March 2000.

Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil and South Korea and there are also over 30 regulatory submissions pending around the world. Discussions are being initiated with regulatory authorities with a view to relinquishing licenses where granted and withdrawing all regulatory submissions.

Glaxo Wellcome
29 November 2000

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

 20 November 2017 
Barriers to hepatitis C treatment
 20 November 2017 
Socioeconomic characteristics in diverticular disease
 20 November 2017 
Endoscopic indices of disease activity for Crohn’s
 17 November 2017 
Food elimination diets for treatment of adults with eosinophilic esophagitis
 17 November 2017 
PPI use and cognitive function in women
 17 November 2017 
Predicting microscopic colitis
 16 November 2017 
NAFLD-hepatocellular carcinoma and survival after orthotopic liver transplant
 16 November 2017 
Prepregnancy obesity and severe maternal morbidity
 16 November 2017 
Celiac disease screening in adult first-degree relatives
 15 November 2017 
Breastfeeding and the risk of IBD
 15 November 2017 
Medication nonadherence and health care costs
 15 November 2017 
Predicting recurrence after curative rectal cancer surgery
 14 November 2017 
HBV/HCV coinfection and cirrhosis
 14 November 2017 
Sexual dysfunction after rectal cancer surgery
 14 November 2017 
Eosinophilic gastroenteritis and colitis
 13 November 2017 
GI bleeding in patients taking non–vitamin K antagonist oral anticoagulants
 13 November 2017 
Genetic polymorphisms, fatty acids and ulcerative colitis
 13 November 2017 
Flares after immunomodulator withdrawal in Crohn's
 10 November 2017 
Thiopurines vs TNF and lymphoma risk in IBD
 10 November 2017 
Drug monitoring of anti-tumour necrosis factor therapy in IBD
 10 November 2017 
Treatment decisions for older patients with colorectal cancer
 09 November 2017 
Quality standards in upper gastrointestinal endoscopy
 09 November 2017 
Irradiated rectal cancer and chemoradiotherapy
 09 November 2017 
Environmental factors and IBD
 08 November 2017 
Prophylaxis of spontaneous bacterial peritonitis
 08 November 2017 
Optimal management of postoperative Crohn's disease
 07 November 2017 
Community Screening for Helicobacter pylori
 07 November 2017 
Early readmission in IBD patients
 07 November 2017 
Mesocolic excision for colon cancer
 06 November 2017 
Food elimination diet for children with eosinophilic esophagitis
 06 November 2017 
Biologic agents and obesity in children with IBD
 06 November 2017 
Liver cancer burden despite extensive use of antiviral agents
 03 November 2017 
Statins and mortality in chronic viral hepatitis
 03 November 2017 
Propofol for outpatient colonoscopy
 03 November 2017 
Asthma and IBD development
 02 November 2017 
Diverticulitis and emergency department burden
 02 November 2017 
Rural residence and risk of IBD
 02 November 2017 
Sexual functioning in Hep C
 01 November 2017 
Heartburn relief in adolescents with GERD
 01 November 2017 
Autoimmune pancreatitis in children
 31 October 2017 
Follow-up of positive results on fecal blood tests
 31 October 2017 
Surveillance in ulcerative colitis and Crohn’s disease
 30 October 2017 
Local recurrence after curative rectal cancer surgery
 30 October 2017 
Low-flow ascites pump in refractory cirrhosis
 30 October 2017 
Medical therapy of patients with pediatric-onset IBD
 27 October 2017 
NAFLD in advanced fibrosis in the USA
 27 October 2017 
Early readmission in cirrhosis after bacterial infections
 26 October 2017 
Predicting response to anti-TNF therapy in Crohn's
 26 October 2017 
Conversion to open laparotomy in rectal cancer
 25 October 2017 
Conversion of colonoscopy to sigmoidoscopy
 25 October 2017 
Fecal microbiota transplantation
 25 October 2017 
Rifaximin and survival in hepatic encephalopathy
 24 October 2017 
Eosinophilic esophagitis with swallowed topical corticosteroids
 24 October 2017 
Meta-analysis in nutritiona research
 23 October 2017 
NAFLD-related hepatocellular carcinoma in liver resection
 23 October 2017 
Outcome of hepatic sarcoidosis
 20 October 2017 
Conversion of planned colonoscopy to sigmoidoscopy
 20 October 2017 
Hospital readmissions reduction program
 19 October 2017 
Surgical anastomosis at 1-year colorectal cancer surveillance
 19 October 2017 
Fecal immunochemical tests in colorectal cancer screening

Blackwell Publishing


GastroHep.com is a Blackwell Publishing registered trademark
© 2017 Wiley-Blackwell and GastroHep.com and contributors
Privacy Statement
Disclaimer
About Us