(PRWEB) March 29, 2001
1,105 suffers of Irritable Bowel Syndrome sign petition sent to FDA and GlaxoSmithKline
Atlanta, Ga - Mar 26, 2001 -- Four months after the withdrawal of Lotronex from the market, Irritable Bowel Syndrome (IBS) sufferers are sick, tired and out of medication. But they will not give up hoping for a return of their miracle drug without a fight.
Members of the Lotronex Action Group (LAG), with support from the IBS Self Help Group and DrugVoice, presented both the Federal Drug Administration (FDA) and Lotronex manufacturer GlaxoSmithKline yesterday with a petition demanding that Lotronex be made available for those who suffer from diarrhea-predominant IBS.
The petition contains the signatures of more than 1,100 sufferers of IBS and their loved ones.
"Allowing pain and suffering to continue when there is a remedy seems to be the greatest indignity possible -- an offense of cruelty beyond belief," says Hope Marcus, a 12-year veteran of her battle with IBS.
In November 2000, Glaxo Wellcome voluntarily withdrew Lotronex, the first treatment for IBS. The withdrawal followed the deaths of five women who had been taking Lotronex. Whether their deaths were Lotronex-related has yet to be decided.
Members of the LAG, along with many other IBS sufferers, have reported a complete cessation of their IBS symptoms while taking Lotronex. The LAG acknowledges that Lotronex has not helped everyone and that some who took the medication experienced side-effects. However, it is the strong belief of the LAG that Lotronex is safe if dispensed properly, with benefits far outweighing the potential risk for adverse side affects.
Symptoms of diarrhea-predominant IBS include urgent and explosive bowel movements, abdominal cramping, gas and nausea. Research suggests that IBS is one of the most common functional GI disorders. But although IBS is not a life-threatening disease, it can severely diminish a person's quality of life.
"Obviously, those who think living with chronic diarrhea is just an inconvenience have never awakened with cramps so powerful and excruciating that it feels as if you are giving birth over and over again - at 2 am, 3 am, 4 am, 5 am and on and on," Ms. Marcus explains.
About the Lotronex Action Group:
The Lotronex Action Group was organized by members of the IBS Self Help Group (http://www.ibsgroup.org) and former Lotronex users.
The Lotronex Action Group seeks immediate access to the medicine Lotronex (alosetron hydrochloride) while avenues for continued marketing are explored between GlaxoSmithKline and the Food and Drug Administration. Moreover, the LAG ultimately seeks permanent access and safe distribution of the medicine to those diagnosed with IBS-Diarrhea.
The Lotronex Action Group believes the medicine to be safe, if dispensed properly, and that the benefits of Lotronex far outweigh the potential risk for adverse side affects.
About the Irritable Bowel Syndrome (IBS) Self Help Group:
The IBS Self Help Group, 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. It is the premier Internet self help health site about Irritable Bowel Syndrome.
The Irritable Bowel Syndrome Self Help Group, received an unprecedented number of requests for help from Lotronex users. Many have written that they have been driven to despair and cannot imagine going back to the way it was prior to taking Lotronex. These members of the IBS Self Help Group originally formed the Lotronex Action Group.
DrugVoice is a consumer research and strategic advisory firm focused on taking the voice of the consumer to health care leaders. They have conducted research with over 2,000 IBS patients, many of whom were former Lotronex users.
Research revealed a large number of users who experienced life-changing benefits from Lotronex. Others, however either did not benefit or experienced side effects that forced them to discontinue the medication or reduce their dosage. These results indicate that an important need for Lotronex exists, but that it is critical to monitor and target its use to the appropriate patient population.
Lotronex Action Group
Tom R. Bell, Psy.D., Coordinator
Corey Miller, Coordinator
Irritable Bowel Syndrome (IBS) Self Help Group
Jeffrey Roberts, President and Founder
Melissa Krauth, President