Limited Zelnorm use to be allowed despite dangers
Despite substantial dangers associated with Zelnorm, the FDA announced Friday that they will allow limited sales for those who are in “critical” need of the IBS drug. Strict restrictions will be placed on who can receive Zelnorm, and it will remain unavailable for the general population due to an increased risk of heart attacks, strokes and other life-threatening injuries.
>>INFORMATION: Zelnorm Dangers
Zelnorm (tegeserod maleate) was approved in 2002 for treatment of Irritable Bowel Syndrome (IBS). On March 30, 2007, a U.S. Zelnorm recall was requested by the FDA due to an increased risk of heart attacks, strokes, angina and death. Following its removal from the U.S. market, Zelnrom recalls were issued in several countries around the world where the regulatory agencies agreed that the risks outweighed the benefits.
Zelnorm sales will be allowed on a very limited basis for those meeting specific and strict guidelines. Through the program, known as an Investigational New Drug (IND) protocal, those meeting the following criteria may be able to obtain Zelnorm:
- Women under 55 years old
- Suffer Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
- No pre-existing heart problems
- Must sign a consent form ensuring they are aware of the Zelnorm dangers
- Comparable satisfactory or effective treatments must not be not available, and
- User must be in “critical” need of Zelnorm
The Zelnorm recall will remain in effect for general use, as the FDA continues to indicate that the dangers outweigh the potential benefits in most cases.
Irritable Bowel Syndrome is not a life-threatening condition, but it can be disabling in extreme cases. IBS problems often involve cramping, abdominal pain, bloating, constipation and diarrhea. Although it does not cause permanent injury to the intestines or lead to more serious conditions, in severe cases the discomfort caused can leave the IBS sufferer unable to work or conduct activities of daily living.
Those who feel that they are in critical need of Zelnorm should contact their doctor to determine if they meet the requirements for the IND Zelnorm sales.
ZELNORM RECALL LAWSUITS
Since the March 2007 recall, the lawyers at Saiontz & Kirk, P.A. have been investigating Zelnorm lawsuits on behalf of injured users. The strict limitations placed on any use of Zelnorm highlights the insufficient warnings which were provided to earlier users. If information had been provided regarding the dangers of Zelnorm, many serious and potentially fatal injuries could have been prevented.
If you, a friend or family member suffered a heart attack, stroke, ischemic colitis or death, request a free claim evaluation to determine if you are eligible for a Zelnorm lawsuit.
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