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Questions and Answers on
Zelnorm (tegaserod maleate)
1. What prompted FDA to work with Novartis to alert the public
to new safety information about Zelnorm?
Since the time of Zelnorm’s initial marketing in the U.S. in
August 2002 through March 2004, FDA’s postmarketing adverse event
reporting system has received reports of patients taking Zelnorm who
experienced serious adverse events. These reports include 21
patients taking Zelnorm who have experienced serious consequences of
diarrhea, 20 patients who have been diagnosed with ischemic colitis,
and 3 patients diagnosed with other types of intestinal ischemia.
In some patients, these adverse events have led to hospitalization,
surgery, and even death.
As a result, FDA is announcing that the labeling of Zelnorm will
be updated to include this important new risk information for
doctors and patients. Although it has not been established that use
of Zelnorm caused these adverse events, this new information will
allow physicians and patients to better understand the potential
risks and benefits of Zelnorm and make informed treatment decisions.
2. What is Zelnorm?
Zelnorm is a medicine used for the
short-term treatment of women who have irritable bowel syndrome
(IBS) with constipation (hard stools or difficulty passing stools)
as their main bowel problem. IBS is a disorder that interferes with
the normal functions of the large intestine (colon). Symptoms may
include cramps, abdominal pain, bloating, constipation, and/or
diarrhea. The cause of IBS is not known.
Zelnorm works by increasing the
movement of stools through the bowels. For those patients who are
helped, Zelnorm reduces pain and discomfort in the abdominal area,
bloating, and constipation.
Zelnorm is not a cure for IBS and does
not work for all women who use it. FDA does not have evidence that
Zelnorm is effective in men with IBS.
3.
3.
What new changes are being made to the Zelnorm label?
The major changes to the Zelnorm label
include a new warning about serious consequences of diarrhea, a new
precaution about ischemic colitis and other forms of intestinal
ischemia, and updated labeling for patients that includes
information about these potential side effects and advises that
patients should stop taking Zelnorm and contact their doctor.
4.
4. What are serious consequences of diarrhea?
Serious consequences that can occur
when patients experience large amounts of diarrhea include
dehydration, low blood pressure, and fainting. In some of the
reported cases in patients taking Zelnorm, these complications have
required hospitalization for rehydration.
5. What is ischemic colitis?
Ischemic colitis is a condition
resulting from reduced blood flow to the intestines, which in some
cases can cause serious intestinal damage, and rarely death. Some
of the signs and symptoms of ischemic colitis are new or worsening
abdominal pain, fever, vomiting, bloody diarrhea, rectal bleeding,
and low back pain.
Sometimes ischemic colitis is mild and
may resolve by itself. However, other times ischemic colitis can
lead to serious problems requiring surgery and in rare cases can
lead to death.
FDA has received 20 reports of ischemic
colitis in people taking Zelnorm, however, at this time we are not
able to determine whether these events were caused by Zelnorm. It
is possible that these events were not caused by Zelnorm, but rather
by some other cause including other diseases that the patient may
have or other drugs the patient was taking.
6. What is intestinal ischemia?
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.
7. Who should not use Zelnorm?
Patients should not start taking Zelnorm if they have:
- diarrhea now or have diarrhea often
- bad kidney or liver disease
- ever had bowel obstruction (intestinal blockage), symptomatic
gallbladder disease, or abdominal adhesions causing pain and/or
intestinal blockage.
8. How should Zelnorm be taken?
The recommended dosage of Zelnorm is 6
mg taken twice daily orally before meals for 4 to 6 weeks. For those
patients who respond to therapy at 4-6 weeks, an additional 4-6 week
course can be considered.
9. Is Zelnorm safe to use?
Patients should understand that all
drugs have risks and a determination by FDA that a drug is safe and
effective does not mean that the drug is risk free. FDA will
approve a drug if it determines that the benefits of the drug exceed
the risks for the approved use as directed by the labeling. When
FDA approves a drug, the labeling includes information on the
benefits and risks and the appropriate dosing regimens so that
doctors and patients can make informed individual treatment
decisions.
Data from clinical trials and
post-marketing reports have identified serious consequences of
diarrhea in patients treated with Zelnorm and this potential adverse
effect appears to be related to the effects of the drug. In
addition, post-marketing reports have identified ischemic colitis
and intestinal ischemia as potential adverse effects that may occur
in patients receiving Zelnorm. While the available data do not
allow FDA to determine whether the reports of ischemic colitis and
intestinal ischemia are caused by Zelnorm, it is important that
doctors and patients be aware of these potential risks as they
assess the potential benefits of treatment with Zelnorm in
individual patients.
Patients should ask their doctor
whether Zelnorm is right for them. Patients should consult their
doctor if they develop symptoms such as severe diarrhea, dizziness,
fainting, new or worsening abdominal pain, or blood in the stools
with or without abdominal pain.
10. Does Zelnorm cause serious consequences of diarrhea?
In some patients Zelnorm can cause severe diarrhea that can
result in dehydration, low blood pressure, dizziness, fainting, or
the need for hospitalization.
11. Does Zelnorm cause ischemic colitis and intestinal
ischemia?
At this time we don’t know if Zelnorm
is causing ischemic colitis or intestinal ischemia. We don’t know
if these events are due to another reason such as an interaction
with another medical condition or an added medication. However,
because of the reports of ischemic colitis and intestinal ischemia
in Zelnorm users, FDA would like the medical community and patients
to be aware of the possible link. This will allow patients to seek
prompt medical care should they get any of the signs or symptoms of
ischemic colitis.
12. What are other side effects of Zelnorm?
The most common side effects of Zelnorm
include:
-
Headache
-
Abdominal pain
-
Diarrhea
-
Nausea
-
Dizziness
These are not all the possible side
effects of Zelnorm. Doctors or pharmacists can provide patients
with additional information on the side effects of Zelnorm.
13. Are there other drugs used to treat IBS with constipation?
Patients are often treated with diet,
exercise, fiber, and various medicines to help relieve
constipation. There is no other FDA approved medication for IBS
with constipation.
14. If a patient wants to discuss their treatment with Zelnorm
what should they do?
Patients should discuss questions and
concerns with their doctor.
If patients have further questions
about Zelnorm, they may contact the Center for Drug's Division of
Drug Information at: 888-INFO.FDA (888-463-6332), or email us at:
druginfo@fda.hhs.gov
Patients may also contact Novartis
directly at 1-862-778-8300.
15. Is Zelnorm going to be taken off the market?
FDA is not thinking of taking Zelnorm
off the market at this time. We are adding new information about
potential risks of treatment with Zelnorm to the labeling so that
doctors and patients can make informed individual treatment
decisions. FDA is also encouraging doctors and patients to report
any similar events to FDA so that we can further understand these
events and their association with Zelnorm use.
Today’s announcement by FDA and Novartis is an effort to minimize
risks and maximize benefits of Zelnorm by ensuring that patients and
doctors fully understand these risks and benefits.
16. Is Zelnorm going to have restricted marketing like
Lotronex?
FDA has not requested any restrictions
on the marketing or distribution of Zelnorm. We will continue to
carefully evaluate post-marketing reports in patients receiving
Zelnorm and consider any additional changes to labeling or other
risk management steps that may be necessary as we gain a better
understanding of these events. We encourage doctors and patients to
report possible adverse events to FDA’s MedWatch program at
www.fda.gov/medwatch or call 1-800-FDA-1088.
17. What should patients do if they think they are having side
effects from Zelnorm?
Patients should call their doctor right
away if they think they are having side effects from Zelnorm.
FDA has received reports of Zelnorm
users who have fainted because of low blood pressure due to severe
diarrhea caused by Zelnorm. FDA is advising patients who faint
while taking Zelnorm to stop the drug immediately and see their
doctor at once.
If patients experience blood from the
rectum, bloody diarrhea, and/or new or worse abdominal pain, they
should stop taking Zelnorm immediately and see their doctor who may
need to perform additional tests.
To gather more safety information about
Zelnorm, FDA is asking that doctors and patients report cases of
suspected adverse effects from Zelnorm to FDA’s MedWatch Program at:
www.fda.gov/medwatch and click on "How
to Report" or by calling 1-800-FDA-1088.
18. Does the current labeling for Zelnorm warn about diarrhea?
Yes, the first FDA approved labeling for Zelnorm described cases
of diarrhea that were seen in clinical trials. Postmarketing
surveillance has identified additional cases of diarrhea, some of
which were serious enough to cause low blood pressure and fainting
and the need for hospitalization for intravenous fluids. FDA has
been working with the company to update its labeling to emphasize
the serious nature of the diarrhea that some users might experience.
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Date created: April 28, 2004, updated April 2, 2008 |
