What is Zelnorm
Zelnorm, which has the generic name of tegaserod, is marketed by Novartis. It is prescribed to treat irritable bowel syndrome (IBS) in women; it is also used to treat constipation. IBS is a disorder that interferes with the normal functions of the large intestine. Symptoms may include cramps, abdominal pain, bloating, constipation, and diarrhea. Zelnorm works by increasing the movement of stools through the bowels. It has not been demonstrated effective in men. Zelnorm works by increasing the action of serotonin in the intestines. This speeds the movement of stools through the bowels. In successful cases, Zelnorm reduces pain and discomfort in the abdominal area, bloating, and constipation.
Zelnorm Recall
On March 30, 2007, the FDA ordered that Novartis stop marketing Zelnorm based on the findings of an increased risk of serious heart problems associated with use of the tegaserod. Novartis agreed to voluntarily suspend marketing of Zelnorm in the United States. The FDA advises those who are using Zelnorm to speak with their doctors 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.
The FDA concluded, based on the data that for most Zelnorm patients, the benefits of this drug no longer outweighed the risks. Data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher in Zelnorm patients than with patients who took placebos. 13 Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, while only 1 placebo-treated patient (or 0.01%) had such an event.
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In addition, Zelnorm has also been linked to ischemic colitis and potentially death. The FDA received 16 reports of patients required hospitalization due to these effects. The FDA has received 20 reports of ischemic colitis, plus three reports of a similar intestinal problem. 14 patients were hospitalized, and four died. Accordingly, the FDA has ordered that a precaution about this condition go on Zelnorm's label, along with a more prominent warning about severe diarrhea.
Zelnorm Side Effects
Serious side effects associated with Zelnorm include difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives). In this case, stop taking this medication and seek emergency medical care. Less serious side effects include diarrhea, cramping, and abdominal pain, joint pain, headache, dizziness or migraine
Questions and Consultations
If you or a family member has used the prescription drug Zelnorm and noticed adverse side effects, you should contact a physician immediately. If you would like to discuss your rights, are interested in more information on Zelnorm litigation, or if you have information about the cases that you would like to share with us, please fill out the short evaluation form below and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Zelnorm. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
Link To Lawyer Seek's Zelnorm Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Zelnorm-P155/'>Zelnorm: Lawyer Seek</a> |
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