On
March 30, 2007, the FDA ordered that Novartis Pharmaceuticals Corporation,
“willingly” stop marketing Zelnorm (generic: tegaserod) based on the recent
findings of an increased risk of serious cardiovascular adverse events (heart
problems) associated with the use of the drug. Accordingly, Novartis has agreed
to voluntarily suspend marketing of the drug in the United States. The FDA is
currently advising patients who are using Zelnorm to get in touch with their
health care providers to discuss treatment alternatives. Patients who are taking
Zelnorm should seek emergency medical care if they experience severe chest pain,
shortness of breath, dizziness, sudden onset of weakness or difficulty walking
or talking, or other symptoms of a heart attack or stroke.
Throughout February and March 2007, Novartis reported to the FDA the results of
a new analysis of 29 short-term (1-3 months) randomized, controlled clinical
trials of Zelnorm. The FDA concluded, based on the data that for most patients
the benefits of this drug no longer outweigh the risks. The analysis included
more than 11,600 patients treated with Zelnorm and over 7000 patients treated
with placebo. The data showed that the risk of serious cardiovascular adverse
events (e.g., angina, heart attacks, and strokes) associated with the use of
Zelnorm is higher than with placebo treatment. Thirteen (13) Zelnorm related
patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1
placebo-treated patient (or 0.01%) with an event.
Additionally, Zelnorm has been linked to serious cases of diarrhea, ischemic
colitis and potentially death. As a result, the FDA has ordered that a
precaution about the intestinal condition go on Zelnorm’s label, along with a
larger warning about severe diarrhea. Zelnorm is used to speed the colon’s
movement of stools.
The FDA has received 21 reports of diarrhea so severe that it caused such
complications as low blood pressure and fainting. Sixteen (16) of these patients
required hospitalization. The FDA has received 20 reports of ischemic colitis,
plus three reports of a similar intestinal problem. Fourteen (14) patients were
hospitalized and four died.
Zelnorm should not be used by anyone who frequently experiences diarrhea, and
should be stopped immediately if patients get dizzy or faint, the FDA said.
Irritable bowel syndrome is a mysterious disorder that gives millions of people,
mostly women, abdominal pain and either severe diarrhea or constipation or both.
Zelnorm is the only FDA approved therapy for the constipation causing form of
the ailment. It is supposed to be used only by women.
Contact Us
Davis & Feder P.A. is now handling claims for individuals who have suffered a
heart attack or stroke while taking Zelnorm. Davis & Feder P.A. is experienced in
pharmaceutical product liability cases and settlements. If you or a loved one
has suffered a heart attack or stroke while taking Zelnorm, contact us at
1-866-857-8400 or send us an email at info@markdavispc.com.
On
March 30, 2007, the FDA ordered that Novartis Pharmaceuticals Corporation,
“willingly” stop marketing Zelnorm (generic: tegaserod) based on the recent
findings of an increased risk of serious cardiovascular adverse events (heart
problems) associated with the use of the drug. Accordingly, Novartis has agreed
to voluntarily suspend marketing of the drug in the United States. The FDA is
currently advising patients who are using Zelnorm to get in touch with their
health care providers to discuss treatment alternatives. Patients who are taking
Zelnorm should seek emergency medical care if they experience severe chest pain,
shortness of breath, dizziness, sudden onset of weakness or difficulty walking
or talking, or other symptoms of a heart attack or stroke.