Dr. Mercola August 07 2002 4,222 views
The FDA has approved the first drug to treat one form of irritable bowel syndrome (IBS) in women. Novartis Pharmaceuticals ' Zelnorm (tegaserod maleate), primarily for women whose main IBS symptom is constipation, will be released early this fall.
The FDA pointed out that Zelnorm doesn't cure IBS and is not for treating IBS whose main symptom is diarrhea. The FDA's approval decision was based on three studies during which, in a three-month period, the drug was shown to reduce constipation, bloating and abdominal discomfort. The FDA noted that effects were greatest after one month, reducing each month thereafter. Effects after three months were not studied.
Novartis said Zelnorm is the first in a new class of drugs called serotonin-4 receptor agonists, activating these receptors to stimulate the peristaltic reflex to normalize the gastrointestinal tract's motility. Side effects include headaches and diarrhea. Novartis also noted there are no marketing restrictions in place for Zelnorm, unlike the earlier drug for IBS from GlaxoSmithKline, Lotronex, that was removed from the market in 2000 for safety concerns. Novartis estimates the potential market for its new drug is 10 million women in the U.S. The drug is already approved in 30 other countries. Finally, Novartis is investigating the use of Zelnorm for other disorders, including chronic constipation and indigestion.
Another crazy drug for a symptom complex that is virtually 100% curable with diet and emotional work.
Let's be proactive on this one. There were concerns raised about this drug's effectiveness last year. It was unclear if the drug is effective. None of the three pivotal trials demonstrated efficacy according to the original protocol. Even after Novartis altered the parameters of the trial, lowering the threshold for efficacy, just one of the two remaining trials showed some efficacy, and that was modest. It would be interesting to see how Novaritis manipulated the data to get this drug approved.
A drug-based solution for IBS makes absolutely no sense. If the eating plan does not improve it, my experience is that there is usually an underlying emotional stress or anxiety. EFT is an excellent tool to address this stress. Consider my EFT video series for an in-depth exploration of how to make EFT work for you; you can also view a free manual to see EFT and my videos may be right for you.
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I am appaled at his lack of empathy for those whose IBS is chronic and long term. my IBS is not "psychological" nor has it ever been cured by diet, water or excercise. Zelnorm has worked so incredibly for me and thousands of other women. As well, in the last 3 years I've taken it, its effectivness has not diminished. perhaps mercola just wants to sell his prodicts at our health expense.