Sunday, May 27, 2007

IBS Self Help Group reacts to withdrawal of Lotronex by Glaxo Wellcome

IBS Self Help Group reacts to withdrawal of Lotronex by Glaxo Wellcome

(PRWEB) December 7, 2000

Many Lotronex users view the withdrawal as having a very negative impact on their lives

TORONTO, Ontario, Dec 5 - The Irritable Bowel Syndrome Self Help Group, (www. ibsgroup. org), has received an unprecedented number of requests for help from Lotronex users due to Glaxo Wellcome's announcement that, at the request of the US Food and Drug Administration (FDA), it will voluntarily withdraw Lotronex, its treatment for irritable bowel syndrome (IBS), from the US market. Many have written that they have been driven to despair and cannot imagine going back to the way it was prior to taking Lotronex.

A member of the IBS Self Help Group wrote "I am one of many people whose lives were changed when I tried Lotronex. This is after literally 30 years with IBS. Nothing worked for me, and I had tried it all. I remember the feeling of let down I had every time I left the gastroenterology office, and I was given nothing knew. Lotronex radically changed my body and my life. I became more sociable and responsible at work, enjoyed eating more, and had a rosier future when I planned trips that I would not have taken otherwise."

Members of the IBS Group have written to the FDA and spoken directly to Glaxo in an effort to tell them the positive effects of the drug. Many write that with the right adjustment to their own dosage of Lotronex that they were able to prevent, or control, the primary side-effect of constipation. The Public Citizen, a nationwide consumer organization which petitioned the FDA to remove Lotronex from the market, suggested to the FDA that "the adverse reactions tip the risk-benefit equation against using the drug." They characterized IBS "as a poorly defined disease although capable of causing significant distress in some individuals," which upset many members as being very dismissive of an illness which affects their everyday life.

The IBS Self Help Group undertook a Lotronex survey on IBSwatch. com (www. ibswatch. com) to capture members experiences with the drug and their reaction to the FDA's request to have Lotronex withdrawn. Survey takers overwhelmly indicated that they benefited from Lotronex and oppose Glaxo Wellcome's decision to withdraw Lotronex.

"I understand that expert counsel from a number of gastroenterologists believed that Lotronex had an unacceptable risk/benefit ratio and this was taken into consideration by Glaxo prior to voluntarily withdrawing the drug," said Jeffrey Roberts, President and Founder ofthe Irritable Bowel Syndrome (IBS) Self Help Group. Mr. Roberts continues, "The withdrawal is a regrettable situation given the apparent thousands of women who have benefited from Lotronex. Safety is paramount and must always be considered, however, I urge the FDA and Glaxo to continue discussions about Lotronex and make decisions for or against the use of it in the face of further investigations."

About the Irritable Bowel Syndrome (IBS) Self Help Group:

The IBS Self Help Group is the premier internet self help health site about Irritable Bowel Syndrome, with more than 200,000 Bulletin Board member postings about the functional gastrointestinal disorder Irritable Bowel Syndrome and largest provider of health related information for sufferers of IBS.

The IBS Self Help Group (ibsgroup. org), formed in 1987, is in support of those who suffer from IBS, those who are looking for support for someone who has IBS, and medical professionals who want to learn more about IBS. The IBS website was launched in May 1995. The IBS Self Help Group website provides access to bulletin and chatboards, book list and store, medication listing, clinical study listings and helpful information. All revenues from sponsorship, affiliation and donations go directly to funding the activities of the IBS Self Help Group. The IBS Group has several sponsors which assist in supporting the group's activities. Sponsorship information is available at http://www. ibsgroup. org/main/sponsor. htm (http://www. ibsgroup. org/main/sponsor. htm)



Irritable Bowel Syndrome (IBS) Self Help Group

Jeffrey Roberts, President and Founder

Jeffrey-roberts@ibsgroup. org

416.932.3311, fax,416-932-8909

Www. ibsgroup. org