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Zelnorm Side Effects May Be Linked To Heart Attack Lawsuits
Zelnorm | Lawyers, Lawsuits | Side Effects: Heart Problems, Cardiovascular, Heart Attacks, Strokes
Our Zelnorm side effect lawyers are offering free case evaluations to anyone who suffered cardiac injuries or other side effects linked to Zelnorm. Zelnorm was first approved in 2002 to treat constipation associated with Irritable Bowel Syndrome (IBS), and its approved uses was later expanded to include chronic constipation in patients under 65 years of age. However, Zelnorm was removed from the market after it was linked to a high risk of cardiac side effects including heart attacks and stroke. The Zelnorm side effect lawyers at our firm have helped hundreds of Zelnorm patients receive compensation for injuries caused by this defective drug. Our Zelnorm side effect lawyers and attorneys are dedicated to making sure those injured by Zelnorm get the justice they deserve.
When Zelnorm was introduced to the market by Novartis AG, it was hailed as a breakthrough in the treatment of constipation associated with IBS. IBS, also known as spastic colon, is a functional bowel disorder characterized by abdominal pain and changes in bowel habits which are not associated with any abnormalities seen on routine clinical testing. It is fairly common and makes up 50% of visits to gastroenterologists.
Zelnorm works by causing nerve cells to speed the elimination of stools, effectively putting an end to constipation through the imitation of serotonin in the gut. While there is no known cure for IBS, Zelnorm did provide many sufferers with significant relief from symptoms. IBS can seriously disrupt the lives of patients, and it is understandable why so many sufferers would have been anxious to use Zelnorm. However, as the investigation conducted by our Zelnorm side effect lawyers has determined, in many patients, this dangerous drug caused far more problems than it solved.
Zelnorm Recalled For Serious Cardiac Side Effects
Between February and March 2007, Novartis reported the results of an analysis of 29 Zelnorm studies. The majority of those Zelnorm studies followed patients for 1-3 months in controlled clinical trials. The analysis included more than 11,600 patients treated with Zelnorm and over 7,000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm was higher than with placebo treatment. Thirteen Zelnorm-treated patients had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient experienced such an event.
In March 2007, Novartis "voluntarily" withdrew Zelnorm from the market at the strong urging of the FDA. At the same time, the FDA advised patients who were using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who were taking Zelnorm were also warned by the FDA to seek emergency medical care if they experienced 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. Our Zelnorm side effect lawyers are convinced that Novartis should have moved faster to remove Zelnorm from the market, or at the very least, Zelnorm patients should have been given strong warnings that the drug was linked to serious cardiac side effects. The Zelnorm side effect lawyers at our firm will make sure that Novartis is held accountable for this negligence.
Zelnorm Returned to Market Under Tight Restrictions
The March 2007 decision to suspend marketing of Zelnorm was not the end of this defective drug. In July 2007, the FDA announced that it was actually allowing Novartis to market Zelnorm as an investigational new drug, so long as the use of Zelnorm was restricted to the treatment of IBS with constipation and chronic idiopathic constipation (CIC) in women younger than 55 who met specific guidelines.
It is important to note that an investigational new drug such as Zelnorm is not an approved drugs. In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment investigational new drug protocol, when no comparable or satisfactory alternative drug or therapy is available. Some patient advocates, including our Zelnorm side effect lawyers, have questioned if IBS meets the criteria for treatment with investigational new drugs.
The FDA said that in order for patients to be prescribed Zelnorm, they must meet strict criteria and have no known or pre-existing heart problems and be in critical need of the drug. Despite these guidelines, our Zelnorm side effect lawyers believe the FDA made a serious error in allowing Zelnorm to return to the market in any fashion. There are other medications that treat the symptoms of IBS, and lifestyle and diet changes that can help mitigate suffering for IBS patients who no longer have access to Zelnorm. Like many patient advocates, our Zelnorm side effect attorneys do not believe that the benefits of Zelnorm outweigh its serious risks.
Other Zelnorm Side Effects
While cardiac problems are among the most serious side effects caused by Zelnorm, they are not the only safety issues presented by this drug. Our Zelnorm side effect lawyers are also offering free consultations to Zelnorm users who suffered from other problems as a result of this treatment, including cases of ischemic colitis, some of which were fatal.
In April 2004, the FDA announced that Novartis would be modifying the Zelnorm label to include warnings about ischemic colitis and severe diarrhea associated with the drug. Ischemic colitis is a medical condition in which inflammation and injury of the large intestine result from inadequate blood supply. Ischemic colitis presents with severe abdominal pain and the passage of bloody stools. In severe cases of ischemic colitis, fluid can leak through the damaged colon lining, which can lead to the development of sepsis and can even result in death. The FDA said that between 2002 and 2004, it had received 20 reports of ischemic colitis associated with the use of Zelnorm. Fourteen of these patients required hospitalization and four died.
At the same time, the FDA also warned that the use of Zelnorm had caused severe diarrhea in some patients. The FDA said it had received 21 reports of diarrhea in Zelnorm patients so severe that it caused such complications as low blood pressure and fainting. Sixteen of those patients experienced diarrhea so severe that they required hospitalization.
As result of the ischemic colitis and severe diarrhea attributed to Zelnorm, Novartis changed the drug's package insert to warn of these side effects. The FDA also said Zelnorm should not be used by anyone who frequently experiences diarrhea, and should be stopped immediately if patients get dizzy or faint. The Zelnorm side effect attorneys at our law firm know how devastating ischemic colitis and the severe diarrhea caused by Zelnorm can be, and we have represented many victims of these Zelnorm side effects.
Legal Help for Victims of Zelnorm Side Effects
If you or someone you know suffered cardiac problems - including heart attack or stroke - ischemic colitis or any other Zelnorm side effect, you have valuable legal rights. Please fill out our online form or call us at 1-800-YOURLAWYER (1-800-968-7529) for a free consultation with an experienced Zelnorm side effect lawyer.