>>INFORMATION: Zelnorm Dangers

Zelnorm (tegeserod maleate) was approved in 2002 for treatment of Irritable Bowel Syndrome (IBS).  On March 30, 2007, a U.S. Zelnorm recall was requested by the FDA due to an increased risk of heart attacks, strokes, angina and death.  Following its removal from the U.S. market, Zelnrom recalls were issued in several countries around the world where the regulatory agencies agreed that the risks outweighed the benefits.

Zelnorm sales will be allowed on a very limited basis for those meeting specific and strict guidelines.  Through the program, known as an Investigational New Drug (IND) protocal, those meeting the following criteria may be able to obtain Zelnorm:

• Women under 55 years old
• Suffer Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
• No pre-existing heart problems
• Must sign a consent form ensuring they are aware of the Zelnorm dangers
• Comparable satisfactory or effective treatments must not be not available, and
• User must be in “critical” need of Zelnorm

The Zelnorm recall will remain in effect for general use, as the FDA continues to indicate that the dangers outweigh the potential benefits in most cases.

Irritable Bowel Syndrome is not a life-threatening condition, but it can be disabling in extreme cases.  IBS problems often involve cramping, abdominal pain, bloating, constipation and diarrhea.  Although it does not cause permanent injury to the intestines or lead to more serious conditions, in severe cases the discomfort caused can leave the IBS sufferer unable to work or conduct activities of daily living.

Those who feel that they are in critical need of Zelnorm should contact their doctor to determine if they meet the requirements for the IND Zelnorm sales.

ZELNORM RECALL LAWSUITS

Since the March 2007 recall, the lawyers at Saiontz & Kirk, P.A. have been investigating Zelnorm lawsuits on behalf of injured users.  The strict limitations placed on any use of Zelnorm highlights the insufficient warnings which were provided to earlier users.  If information had been provided regarding the dangers of Zelnorm, many serious and potentially fatal injuries could have been prevented.

If you, a friend or family member suffered a heart attack, stroke, ischemic colitis or death, request a free claim evaluation to determine if you are eligible for a Zelnorm lawsuit.

>>REQUEST A ZELNORM LAWSUIT EVALUATION<<

>>INFORMATION: Zelnorm Recall

Questions regarding the safety of Zelnorm (generic tegaserod maleate) surfaced after analysis of clinical data involving 18,000 patients demonstrated that a statistically significant number of cardiovascular events occurred among individuals taking the drug.  The medication provides limited benefits in treatment of irritable bowel syndrome with constipation, yet Zelnorm side effects could cause a 7 to 8 fold increased risk of serious injury or death.

The Swiss are at least the fourth country to require Novartis stop selling the drug, following Zelnorm recalls in Australia, Canada and the United States.  In addition, the drug was rejected two times by the the EMEA (European Medicines Agency) in 2005 and again in 2006. 

At the time Zelnorm was recalled in the United States, it was taken by 500,000 people and had been prescribed over 2.6 million times in 2006.  Thousand of otherwise healthy people could have suffered heart attacks, strokes or other serious injury while trying to obtain relief from the non-life threatening irritable bowel syndrome, since the manufacturer failed to provide adequate warnings regarding the risks associated with Zelnorm.

ZELNORM LAWSUITS

Since early April 2007, the Zelnorm lawyers at Saiontz and Kirk, P.A. have been accepting new cases for users who suffered from ischemic colitis, heart attacks, strokes or death.  Zelnorm lawsuits are being reviewed nationwide, and there are no fees or expenses unless there is a recovery.  To determine if compensation may be available, request a free Zelnorm claim evaluation.

>>INFORMATION: Zelnorm Recall

In July 2002, the FDA approved Zelnorm (generic tegaserod maleate) for use in the United States.  The drug was intended to relieve symptoms of IBS with constipation by increasing movements of stools through the bowels.  However, it has never been very effective and when reports surfaced that Zelnorm side effects could cause serious and potentially fatal cardiovascular problems, the FDA requested that the drug be removed from the market on March 31, 2007.  It was determined that the risks outweighed the limited benefits of the drug.

Shortly after FDA approval, many experts and advocacy groups criticized the decision to approve Zelnorm since there was little proof that it relieved constipation any better than fiber supplements and other alternatives.  In Europe, Zelorm was rejected on two separate occasions.

Clinical studies have shown that Zelnorm provides no benefit for men with IBS-Constipation, and only 5% to 11% of women fared any better when taking the drug.  Therefore, many long-term sufferers have already been searching for an alternative to Zelnorm.

On various websites and internet forums, those with constipation predominant IBS have indicated that some of the following treatment alternatives have shown improvement of symptoms.  This information is not being provided as medical advice, but rather as a summary of information which some have indicated helped them.  None of the following should be tried without first consulting with your physician to discuss the benefits and risks associated with each Zelnorm alternative.

ALTERNATIVES FOR CONSTIPATION

• Milk of magnesia - a fairly mild laxative which is gentle on the stomach
• Miralax - a powerful laxative, which is referred to as an osmotic laxative since it draws water into the bowel
• Amitiza - medication which is designed for chronic constipation
• Kristalose - a prescription laxative which can treat

NATURAL ALTERNATIVES

• Magnesium Supplements - magnesium oxide and magnesium citrate
• Acacia - organic soluble fiber which can help relieve constipation
• Fennel - fennel seed tea can be beneficial for bloating
• Peppermint - enteric coated peppermint oil has been reported to relieve and prevent abdominal pain, bloating and discomfort
• Probotic foods - foods which could help calm IBS include sauerkraut, yogurt, cheese, buttermilk, kefir, soy sauce, tofu and unpasteurized beer
• Hypnotherapy - gut-directed hypnotherapy can address the underlying pathology of bowel dysfunctions and improve symptoms

ZELNORM LAWYERS

The Zelnorm lawyers at Saiontz & Kirk, P.A. represent individuals who have suffered a heart attack, stroke or ischemic colitis after taking the IBS drug.  The FDA has indicated that users looking for a Zelnorm alternative should speak with their healthcare providers.  New treatments should always be reviewed with your physician to discuss potential benefits and side effects.

If you, a friend or family member wish to speak with an attorney about your legal alternatives and Zelnorm lawsuits which are being pursued, request a free consultation and claim evaluation.

>>REQUEST A ZELNORM LAWSUIT EVALUATION<<

>>INFORMATION: Zelnorm recall lawsuits

Zelnorm was prescribed for treatment of irritable bowel syndrome (IBS) where constipation was the primary symptom.  The FDA requested that the IBS drug be withdrawn on March 30 after a review of data involving 18,000 patients demonstrated it could increase the risk of heart attacks, strokes and angina.  The recall of Zelnorm now extends to Canada and Australia, as well as the United States.

The side effects of Zelnorm are especially troubling since most users were younger and otherwise healthy individuals.  In addition, the drug has been shown to be an ineffective treatment for most constipation sufferers.  The FDA felt that a Zelnorm recall was appropriate since the risk of serious injury or death outweighs the limited benefits the drug provided for treatment of non-life-threatening IBS.

ZELNORM LAWYERS

If you, a friend or family member believe injuries may have been caused by Zelnorm, request a free claim evaluation.

>>INFORMATION: Zelnorm lawsuits

The FDA identified the problems with Zelnorm after reviewing previous data collected from clinical trials.  Novartis has acknowledged that the analysis identified an imbalance which was statistically significant in the number of heart attacks, strokes and occurrences of angina for individuals who took Zelnorm.

Experts have questioned why this data was not reviewed sooner.  If earlier warnings had been issued it is possible that thousands of serious and potentially fatal injuries could have been prevented.  When Zelnorm was approved in 2002, a small imbalance of angina pectoris was identified, but the makers minimized the risk.  The recent re-review of the entire clinical database by independent experts has demonstrated that that the imbalance is statistically significant, and the product has been withdrawn from the market.

ZELNORM LAWYERS

The drug recall lawyers at Saiontz & Kirk, P.A. represent individuals injured by dangerous drugs and defective medical products nationwide.  Zelnorm lawsuits are being reviewed to obtain compensation for those injured by this drug.  Request a free claim evaluation.