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The Zelnorm Web site states, "Novartis believes that Zelnorm provides important benefits for appropriate patients with irritable bowel syndrome with constipation."
One has to wonder what 'appropriate' means?
On April 28, 2004, the FDA announced that from the time of Zelnorm's initial marketing through March 2004, the agency received reports of patients taking Zelnorm who experienced significant adverse drug reactions including 21 patients who experienced the serious diarrhea, 20 patients diagnosed with ischemic colitis (lack of blood flow to the large intestine), and three patients diagnosed with other types of intestinal ischemia.
In some patients, these adverse Zelnorm events led to hospitalization, surgery, and even death.
Severe diarrhea can lead to dehydration, low blood pressure, and fainting. Some patients taking Zelnorm required hospitalization for dehydration.
Ischemic colitis can cause serious intestinal damage and even death. Symptoms of ischemic colitis are new or worsening abdominal pain, fever, vomiting, bloody diarrhea, rectal bleeding, and low back pain.
Intestinal ischemia is a condition resulting from reduced blood flow to the intestines that can lead to ischemic colitis or to more severe forms of intestinal damage that may require surgery or result in death.
Nevertheless, the FDA approved the Zelnorm even against recommendations from its own independent panel of experts. (Do you wonder if the FDA really cares about your public safety or is greatly influenced by the wealthy army of pharmaceutical lobbyists?) What can you do to fight back if you got sicker from taking Zelnorm?
Novartis Pharma submitted two clinical trials to the FDA in support of Zelnorm's approval for chronic constipation. In the two trials, only nine to 16 percent of the patients were 65 years of age or older and the response to Zelnorm was significantly smaller in older patients. Even Novartis was forced to state in the labeling for the drug, that patients 65 and older showed no significant treatment effects for Zelnorm over placebo.
The Gastrointestinal Drugs Advisory Committee voted 13 to zero not to recommend Zelnorm's approval in older adults. The FDA followed this recommendation.
Only nine to 14 percent of the patients in the two trials were male, and the response to Zelnorm was smaller in males than females. The advisory committee voted eight to five not to recommend the drug be approved for use in men. The FDA unfortunately did not accept this recommendation.
The FDA medical officer who wrote the review for the Gastrointestinal Drugs Advisory Committee meeting summed up the effectiveness of the drug in less than glowing terms:
“In acknowledging the favorable statistics toward Zelnorm, this reviewer ponders about the clinical significance of these efficacy results, in the lifelong treatment of chronic constipation.”
Chronic constipation is a benign condition yet Zelnorm is not a benign drug. Plus Zelnorm is overpriced: A one month supply of Zelnorm at a dose of 12 milligrams per day retails for $153.91. Not only does Zelnorm threaten your life but will bankrupt you too.
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