NOTE: On March 30, 2007 the FDA notified healthcare professionals and
patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used
for the short-term treatment of women with irritable bowel syndrome with
constipation and for patients younger than 65 years of age with chronic
constipation. FDA analysis of safety data pooled from 29 clinical trials
involving over 18,000 patients showed an excess number of serious cardiovascular
adverse events, including angina,
heart attacks, and
stroke, in patients taking
Zelnorm compared to patients given placebo. Patients taking Zelnorm should
contact their healthcare professional to discuss treatment alternatives and seek
emergency medical care if they experience severe chest pain, shortness of
breath, sudden onset of weakness or difficulty walking or talking, or other
symptoms of a heart attack or stroke. Healthcare professionals should assess
their patients and transition them to other therapies as appropriate. Click Here to read the entire FDA Press Release.
Zelnorm Has Serious Side Effects Alert
Zelnorm (tegaserod) is a prescription drug for the short-term treatment of
women with irritable bowel syndrome (IBS). Zelnorm is intended primarily to
treat the constipation that accompanies IBS. (It has never been tested in men.)
Summary: The FDA has added new warning information to the label of the
drug Zelnorm. Patients are warned to stop taking Zelnorm immediately if they
develop rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. These
are symptoms of intestinal ischemia in which the supply of blood and oxygen to
the intestines are compromised. Zelnorm rarely causes severe diarrhea that can result in dehydration and
a need for intravenous fluids. Therefore, Zelnorm also should be stopped if
diarrhea occurs.
Comment: We have been bothered by some of the current Zelnorm
advertising. For example, ads on television present a group of very attractive
women, all smiling and showing off their trim, tanned, well-toned midsections.
One gets the immediate impression that Zelnorm has something to do with being
young, pretty and in great shape. It would not be very glamorous to state on
prime-time TV that Zelnorm is actually intended to "increase the movement
of stools (fecal matter) through the bowels" but that, in fact, is what
this drug is intended to do.
Barbara K. Hecht,
Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com
Related Links
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.
Source: FDA Talk Paper T04-10, April 28, 2004
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