# FDA Updates Zelnorm Labeling with New Risk Information



## Jeffrey Roberts (Apr 15, 1987)

FDA Talk PaperT04-10April 28, 2004 Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA *FDA Updates Zelnorm Labeling with New Risk Information*The Food and Drug Administration (FDA) today announced the addition of new risk information to the health professional labeling for Zelnorm (tegaserod maleate). Zelnorm is a prescription medication for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. The labeling is being revised to ensure health professionals and patients have the most current and complete information available when prescribing and taking Zelnorm. The specific revisions include:
a new warning about the serious consequences of diarrhea associated with the medication;
a new precaution about ischemic colitis and other forms of intestinal ischemia (i.e., reduced blood flow to the intestines);
changes to the adverse reactions section describing post-marketing reports; and
new information in the "Information for the Patient" leaflet.
The new warning states, "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."The new precaution on ischemic colitis states, "Ischemic colitis, and other forms of intestinal ischemia, have been reported in patients receiving Zelnorm during marketed use of the drug. A causal relationship between Zelnorm use and these events has not been established. Placebo-controlled clinical trials of 7,000 patients for 3-month duration showed no cases of these events, and would suggest the rate of these events is low. Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis." Under the post marketing experience heading in the adverse reactions section, the labeling now states, "Voluntary reports of adverse events occurring with the use of Zelnorm include the following: ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, suspected sphincter of Oddi spasm, bile duct stone, and cholecystitis with elevated transaminases. Because these cases are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No causal relationship between these events and Zelnorm use has been established. Hypokalemia secondary to diarrhea has also been reported."The new patient information advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the new labeling advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness or fainting.FDA approved Zelnorm on July 24, 2002, following the recommendation for approval made by FDA's Gastrointestinal Drugs Advisory Committee on June 26, 2000 (see http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01160.html). Zelnorm is the only FDA-approved prescription drug for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.Zelnorm increases the movement of stools (fecal matter) through the bowels. Zelnorm does not cure IBS, nor does it treat diarrhea-predominant IBS. Zelnorm reduces pain and discomfort in the abdominal area, and reduces bloating and constipation. The safety and effectiveness of Zelnorm in men have not been established. In conjunction with today's FDA announcement, the manufacturer of Zelnorm, Novartis Pharmaceuticals Corporation of East Hanover, N.J., has issued a letter to health professionals to highlight the labeling changes. ####Additional Information


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## davidgee (Sep 3, 2003)

Hi Jeff,Thanks for the info on the Zelnorm labeling changes.You do take good care of us.( and I bet you thought nobody reads that stuff)


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## Tiss (Aug 22, 2000)

Thanks Jeff. I have had more dizziness but I do not have diarhea. But I have had a little bit of rectal bleeding. I didn't know it was anything to be concerned about---I think this is from hemmies. What is ischemic colitis? Thanks much for the info.


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## Sdove (Jan 13, 2002)

Thanks Jeff for the information. I sure don't like this new issue... with Zelnorm. It is the only thing that has helped me.Polly


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## Tiss (Aug 22, 2000)

This is a bummer. I don't know whether to see the doctor or not about the dizziness and some of the bleeding. I just know he'll take me off of it even though I am certain the little bit of bleeding was from hemmies. What are the rest of you going to do that are taking Z? Are you worried about these new warnings?


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## NancyG (Sep 1, 2000)

Jeffrey this is what I also got from a friendFDA Issues Warning About IBS Drug Zelnorm Drug Associated With Serious Diarrhea, Reduced Blood Flow to Intestines By Michael Smith, MDWebMD Medical News Reviewed By Charlotte Grayson, MDon Wednesday, April 28, 2004 April, 28 2004 -- The FDA today issued a warning associated with the irritable bowel syndrome (IBS) drug Zelnorm. The FDA says Zelnorm has been associated with serious cases of diarrhea as well as instances of ischemic colitis -- a medical condition where blood flow is reduced to the intestines. Zelnorm is a prescription medication for the short-term treatment of women with IBS whose primary bowel symptom is constipation. The FDA says it's adding this new drug information to ensure doctors and patients have the most current and complete information available when prescribing and taking Zelnorm. The specific revisions include: A new warning about the serious consequences of diarrhea associated with the medication A new precaution about ischemic colitis and other forms of reduced blood flow to the intestines Changes to side effects information section describing information gathered since the drug was approved in July 2002 The New Warning In the new warning, the FDA states that serious consequences of diarrhea, including significant loss of fluid, low blood pressure, and episodes of passing out, have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. The FDA recommends that Zelnorm be discontinued immediately in patients who develop low blood pressure or passing out spells. Zelnorm should not be used in patients who are currently experiencing or frequently experience diarrhea. The New Precaution The FDA has also issued a precaution regarding the risk of reduced blood flow to the intestines, which may lead to inflammation of the intestines, called ischemic colitis. In the new precaution, the FDA states that ischemic colitis and other, similar conditions have been reported in patients taking Zelnorm. Although this association has been observed, the FDA says that Zelnorm has not been proven to cause this effect. The FDA adds that clinical trials comparing Zelnorm to placebo in 7,000 patients for three months showed no cases of these events. This suggests the rate of such events is low, according to the FDA. The agency says Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis. The FDA advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the FDA advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness, or fainting. Zelnorm is the only FDA-approved prescription drug for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation. Zelnorm increases the movement of stools through the bowels. Zelnorm does not cure IBS, nor does it treat the type of IBS where diarrhea is the predominant symptom. Zelnorm reduces pain and discomfort in the abdominal area and reduces bloating and constipation. The safety and effectiveness of Zelnorm in men have not been established. --------------------------------------------------------------------------------Novartis, the maker of Zelnorm, is a WebMD sponsor.


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## NancyG (Sep 1, 2000)

Hi TissThe first day I took the Zelnorm I had a little blood on the tissue and called the doctor and he to said it probably was from hemmies, have had no bad side effects accept for being tired. I got this warning which I will post from a friend. To answer your question I am going to keep taking it as it is the only thing that has relieved the pain and allows me to get rid of the gas easily and it is helping me. I will keep myself informed but am going to keep taking it.Here is what a friend sent to me:FDA Issues Warning About IBS Drug Zelnorm Drug Associated With Serious Diarrhea, Reduced Blood Flow to Intestines By Michael Smith, MDWebMD Medical News Reviewed By Charlotte Grayson, MDon Wednesday, April 28, 2004 April, 28 2004 -- The FDA today issued a warning associated with the irritable bowel syndrome (IBS) drug Zelnorm. The FDA says Zelnorm has been associated with serious cases of diarrhea as well as instances of ischemic colitis -- a medical condition where blood flow is reduced to the intestines. Zelnorm is a prescription medication for the short-term treatment of women with IBS whose primary bowel symptom is constipation. The FDA says it's adding this new drug information to ensure doctors and patients have the most current and complete information available when prescribing and taking Zelnorm. The specific revisions include: A new warning about the serious consequences of diarrhea associated with the medication A new precaution about ischemic colitis and other forms of reduced blood flow to the intestines Changes to side effects information section describing information gathered since the drug was approved in July 2002 The New Warning In the new warning, the FDA states that serious consequences of diarrhea, including significant loss of fluid, low blood pressure, and episodes of passing out, have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. The FDA recommends that Zelnorm be discontinued immediately in patients who develop low blood pressure or passing out spells. Zelnorm should not be used in patients who are currently experiencing or frequently experience diarrhea. The New Precaution The FDA has also issued a precaution regarding the risk of reduced blood flow to the intestines, which may lead to inflammation of the intestines, called ischemic colitis. In the new precaution, the FDA states that ischemic colitis and other, similar conditions have been reported in patients taking Zelnorm. Although this association has been observed, the FDA says that Zelnorm has not been proven to cause this effect. The FDA adds that clinical trials comparing Zelnorm to placebo in 7,000 patients for three months showed no cases of these events. This suggests the rate of such events is low, according to the FDA. The agency says Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis. The FDA advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the FDA advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness, or fainting. Zelnorm is the only FDA-approved prescription drug for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation. Zelnorm increases the movement of stools through the bowels. Zelnorm does not cure IBS, nor does it treat the type of IBS where diarrhea is the predominant symptom. Zelnorm reduces pain and discomfort in the abdominal area and reduces bloating and constipation. The safety and effectiveness of Zelnorm in men have not been established. --------------------------------------------------------------------------------


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## Tiss (Aug 22, 2000)

If a person has ischemic colitis,would this be detected in a routine colonoscopy? I've had several colonoscopies the last 6 years and I've had polyps removed but never had a doctor mention IC. Is this something that the FDA thinks Zelnorm causes or is it already present in ones' body? I'm really trying to decide whether taking Z is worth the risk.


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