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Zelnorm Pulled For Heart Attacks and Strokes
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Zelnorm: True Stories and Interviews
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Zelnorm: Novartis and the FDA do the Two-Step
 Earlier this year Novartis Pharmaceuticals voluntarily removed the pro-motility agent Zelnorm (tegaserod maleate, and prescribed for chronic constipation) from the market after reports of serious adverse events in patients. These included heart attack, stroke, and worsening chest pain that can lead to a heart attack. [ MORE: NOVARTIS & FDA CONFLICT]
Zelnorm: Thank God it didn't Work
 "I first heard about Zelnorm on a TV commercial and how it helps with bloating and swelling. My doctor got the drug approved by my insurance company and I started taking Zelnorm as soon as it came out, around the summer of 2002," says Brenda. "It worked for a few months but it got to the point where I had to also use stool softeners and constipation pills. I was bloated all the time and felt really uncomfortable." [ MORE: ZELNORM CHEST PAINS]
Zelnorm: Is it worth the Risk?
 "About a month ago I was surfing the Internet and saw the recallâ€"I freaked out because I had recently had some issues with my heart. I stopped taking it that very night," says 59-year-old Truitt. On March 30th, Novartis, the drug manufacturer, pulled Zelnorm from the market after the FDA determined the risks outweighed the benefits." [ MORE: ZELNORM - WORTH THE RISK?]
Zelnorm - What recall?
 Zelnorm was pulled from the market on March 30, 2007. But Nancy Harris didn't know about the recall until her doctor phoned the pharmacist to get her prescription renewed. Isn't it the duty of Novartis, the manufacturer of Zelnorm, to notify the medical community when its drug has been linked to heart problems and even death? When its drug has been recalled? [ MORE: ZELNORM RECALL NOTIFICATIONS]
Novartis Withdrawing Zelnorm: But at what Cost?
 At the time it was removed from the market, Zelnorm was one of the 200 most prescribed brand-name medications in the United States, with over 2.6 million prescriptions written during 2006 alone. Sales were $561 million worldwide in 2006, with a 34% increase in total sales over 2005. [ MORE: ZELNORM - WITHDRAW AT WHAT COST?]
Zelnorm: A Husband's Agony
 "Sylvia took one Zelnorm tablet twice a day and she got refills every few months," says Steve (first name only to protect his privacy). "She started to get breathing problems and one day they got so bad that I drove her to ER. The doctors said she was having a heart attack. She quickly went downhill. They air vacced Sylvia to a hospital in Portland and she was kept in a special cardiac unit." [ MORE: ZELNORM CAUSES DEATH]
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More on Zelnorm
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On Mar-30-07 Novartis stopped U.S. sales of its Zelnorm irritable bowel syndrome treatment at the request of the Food and Drug Administration after people taking the medicine had an increase in heart attacks and strokes.
Zelnorm is a prescription medicine prescribed for treatment of Irritable Bowel Syndrome. Irritable Bowel Syndrome is a mysterious disorder that gives millions of people, mostly women, abdominal pain and either severe diarrhea or severe constipation or both. Zelnorm is the only FDA-approved therapy for the constipation-causing form of the ailment. It is intended to be used only by women.
 Zelnorm is used to speed the movement of stools through the colon and has been linked to serious cases of diarrhea, ischemic colitis and even death. As a result, the FDA has ordered that a precaution about the intestinal conditions be placed on the label, along with a larger warning about severe diarrhea.
The FDA has received reports of diarrhea so severe that it caused such complications as low blood pressure and fainting. A number of these patients required hospitalization. The FDA has also received reports of ischemic colitis and reports of a similar intestinal problem. A number of patients were hospitalized and several died.
The FDA warning states that Zelnorm should not be used by anyone who frequently experiences diarrhea, and should be stopped immediately if the patient suffers dizziness or fainting.
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Zelnorm Press Releases
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 JUL-24-07: Of the 11,614 Zelnorm recipients, thirteen developed life-threatening cardiovascular side effects. Among them, four suffered heart attacks and one died. [ MORE: OPPORTUNITIES FOR ZELNORM?]
 JUL-11-07: In May, Swissmedic, a Swiss medical agency, ordered a recall for Zelnorm (also known in some countries as Zelmac). Swissmedic said that the risks associated with Zelnorm were greater than the benefits after a study revealed an increased risk of cardiovascular problems. [ MORE: ZELNORM RECALLED INTERNATIONALLY]
 APR-24-07: Zelnorm has been linked to the death of an otherwise healthy 56-year-old woman with no known heart problems in her own prior medical, or family history. [ MORE: ZELNORM FATALITY]
 The United States Food and Drug Administration (FDA) has announced that, at its request, Novartis Pharmaceuticals has stopped sales of Zelnorm. The action was taken after a study showed increased risk of serious side effects in people taking Zelnorm. [ MORE: ZELNORM - RISKS OUTWEIGH BENEFITS]
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Zelnorm Heart Attack and Stroke in the News:
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JUN-28-07: Zelnorm is the second IBS drug to be taken off the market. It was pulled because of an increased risk of heart attack and stroke. [ NEWS: ZELNORM]
JUN-12-07: The Chinese drug watchdog agency warned patients to stop taking Zelnorm and ordered domestic companies to stop producing and selling the drug. [ FDA NEWS: ZELNORM]
MAY-31-07: Swissmedic, the Swiss medical watchdog, has ordered a market withdrawal for Zelnorm following the FDA's withdrawal earlier this year. [ FORBES: ZELNORM]
MAY-08-07: Last year, an advertisement for Zelnorm was honored as one of the best prescription drug ads. That was before it was discovered that Zelnorm was linked to a higher risk of heart attack and stroke. [ TRIBUNE: ZELNORM]
MAY-02-07: Advertising for Zelnorm may have helped it to become a popular drug, despite its negative side effects and limited effectiveness. [ NEJM: ZELNORM]
APR-03-07: Novartis says it is complying with a request by the FDA that it suspend U.S. sales of Zelnorm, its irritable bowel syndrome treatment. [ C&EN: ZELNORM HEART ATTACK]
MAR-30-07: The Food and Drug Administration has requested that Novartis Pharmaceuticals Corp. voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States; it is currently marketed in 55 other countries. A review of data from 18,000 patients showed that a statistically significant number of people taking Zelnorm had more heart attacks and strokes. [ BLOOMBERG: ZELNORM] [ FDA: ZELNORM]
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Legal Help - Zelnorm Heart Attacks and Strokes
If you reside in Canada, please [ click here] for the Canadian complaint form.
US residents: if you or a loved one has suffered a heart attack or stroke while taking Zelnorm, please click the link below to send your complaint to a lawyer who will review it at no cost or obligation.
Last updated on Nov-19-07
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ARTICLES AND INTERVIEWS
Zelnorm: Novartis and the FDA do the Two-Step
East Hanover, NJ: Earlier this year Novartis Pharmaceuticals voluntarily removed the pro-motility agent Zelnorm (tegaserod maleate, and prescribed for chronic constipation) from the market after reports of serious adverse events in patients. These included heart attack, stroke, and worsening chest pain that can lead to a heart attack. [ Read More ]
Small Window of Opportunity for Zelnorm
Cambridge, MA: Normally, in business, the five-year window represents a long-held expectation for the first tangible signs of success. But such is not the case for Zelnorm. Even though the manufacturer, Novartis Pharmaceuticals made money hand-over-fist with Zelnorm and won marketing accolades, the drug peaked, then faded from view in the time it takes for many businesses just to get established. [ Read More ]
Zelnorm Recalled Internationally
Seattle, WA: Zelnorm, a drug manufactured to treat irritable bowel syndrome, is now being recalled internationally. China is the latest country to issue a recall, announcing last month that it had ordered domestic companies to stop making and selling Zelnorm and warning patients not to take the drug. In the U.S., patients who have taken Zelnorm and suffered adverse reactions are now investigating the possibility of filing lawsuits against Novartis. [ Read More ]
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