On March 30, 2007, the Swiss Pharmaceutical company Novartis announced that it was suspending all marketing and sales of the drug ZelnormŽ due to a request by the Food and Drug Administration.
First approved in 2002, Zelnorm® (tegaserod maleate) is a treatment for irritable bowel syndrome (IBS), an illness that can cause debilitating abdominal pain but is not generally associated with any other abnormal condition. Almost 12 million people in the United States struggle with IBS each year, and it is not unusual for symptoms such as constipation, bloating, and pain to last between five to 10 years. IBS is separated into three categories:
Furthermore, IBS can also develop into a condition called post-infectious IBS (IBS-PI), which generally occurs with an acute onset after an infectious illness that includes fever, vomiting, acute diarrhea, and/or a positive stool culture.
Novartis took this extreme action after it conducted a retrospective analysis of information of more than 18,000 patients they had in their database. This action was due to an ongoing review that involved several health organizations as well as the FDA. The recent analysis of the data suggested that there was a statistically significant imbalance of cardiovascular events between patients taking Zelnorm and those taking a placebo. Some of these cardiovascular events included:
The data revealed that 13 out of 11,614 patients treated with Zelnorm/Zelmac suffered potentially fatal heart incidents as compared to one out of 7,031 people treated with placebos. The FDA asked that Novartis suspend their marketing and sales of Zelnorm in order that public discussion as well as an FDA Advisory Committee meeting can reevaluate the risk/benefit profile of this drug.
If you or someone you love was affected by the side effects of Zelnorm, you must consult an aggressive and experience defective drug attorney immediately. You may be entitled to compensation for your pain and suffering, but if you hesitate the statute of limitations in your state could end your case before it has a chance to begin. Do not let your chance for justice pass you by. Contact us today.
Comments on This Topic:
There are 11 comments related to:
Defective Drugs: News, Statistics and Legal Guide.
| Kimberly says: | 2007-04-05 19:52:31 |
| How do you know if the symptoms you encounter are a result of zelnorm and not your IBS symtoms | |
| Jean Wilson says: | 2007-04-09 11:59:31 |
| I ahve weight loss (unintentional) and have fallen; my legs feel havy sometimes; I get tired verye asily. I took Zelnorm off and on for about a year. i stopped a few months ago. My doctor is putting me through every test in the book. Do you think my symptoms may be related to Zelnorm? | |
| Lucinda Thorne says: | 2007-04-10 16:48:15 |
| I also have been taking zelnorm for the last 3-4 months, and have had weight loss. I have also felt dizzy and get easily tired. (not sure if that is due to working graveyard shift). I have also been having pains and aches in my legs. I also have been getting side aches alot lately. Anyone else having these symptom? | |
| senovia says: | 2007-04-12 13:11:27 |
| I have been taken zelnorm for a little over a year. And i have been going back and forth to the doctor for chest pains pain in my legs nome ness in my arm and legs i\'ve been tested for every thing but my doctor can\'t tell what it is. Just about two weeks before the drug was recalled i felt like i was having a heart attack and went to the hospital a very sharp pain in my chest like some one stab me. | |
| Ellen Radziewicz says: | 2007-04-14 19:59:02 |
| I have been taking Zelnorm for about 2 years and for about a year now I\'ve been having problems pains in my legs & arms and some memory loss, and two times severe chest pain felt like a heart attack My Dr. assumed It was one of my migraine medications and change my prescriptions. I wonder If this could be anything to do with taking Zelnorm. I\'m seeing my Dr. and having all kinds of tests but can\'t seem to find the cause. | |
| feonfly says: | 2007-04-16 17:13:52 |
| Mr A took zelmac for a year, A is also suffered parkinson\'s disease, 1 month ago he collpased due to low BP and heart beat. Could it be due to zelmac? | |
| Frances says: | 2007-04-19 17:09:51 |
| I have been taking Zelnorm since Dec. and it has helped for a little while, but lately I have had tightness in my chest, irregular heart beating (kinda like my heart is fluttering), I am very fatigued and short of breath, I have also had very hyperactive bowel sounds and my stomach aches pretty bad. I am stopping the medicine today, and I think I may see a cardiologist just to make sure. Do you think this may be a little extreme? | |
| Syretta Mason-Davis says: | 2007-04-19 17:47:43 |
| I have been taking zelnorm since 5/2005 and just stop taking it the second week in March. I have been having pain and swelling in the right knee and went to three doctors and they were unable to find the problem. Is is possible this condition is related to Zelnorm | |
| shane says: | 2007-04-25 06:12:58 |
| Similar to what happened with Celebrex and Vioxx, patients with these events had preexisting heart and cardiovascular problems. Read the package insert for common side effects. | |
| Larren says: | 2007-05-03 14:32:41 |
| i have had chest pains while i was on zelnorm...i never went to the doctors for it, how can i prove that the chest pain where a side effect of the medication? | |
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