Yourlawyer.com (Zelnorm News)

FDA Asks Novartis to Suspend Marketing of GI Drug Zelnorm

Mon, 02 Apr 2007 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) notified Novartis Pharmaceuticals Corporation that the company must cease its marketing of Zelnorm (tegaserod), a prescription drug used in the treatment of constipation and irritable bowel syndrome (IBS). According to the FDA, Zelmorm has been associated with an “increased risk of serious cardiovascular adverse events (heart problems).” Novartis has agreed to voluntarily suspend its marketing of Zelnorm.

Zelnorm was first approved by the FDA in 2002 to treat constipated women with IBS, and the approval was expanded two years later to treat chronic constipation in both men and women younger than 65. However, recent randomized trials conducted by Novartis have called into question the drug’s safety, and the FDA now says that “for most patients the benefits of this drug no longer outweigh the risks.” According to the data, “the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment.”

“This decision reflects the FDA’s commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits,” said Dr. Douglas Throckmorton, deputy director for the Center for Drug Evaluation and Research. “Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary.”

The FDA recommends that Zelnorm patients who experience severe chest pain, shortness of breath, dizziness, difficulty walking or talking, or other symptoms of a heart attack or stroke should contact their doctors immediately.

Zelnorm is taken off the market

Sat, 31 Mar 2007 00:00:00 -0700

A widely prescribed drug for severe constipation is being taken off the market after it was linked to a higher risk of heart attacks and strokes, federal regulators said.

Doctors said the voluntary withdrawal of Zelnorm by its manufacturer would leave few options for patients who suffer from a type of irritable bowel syndrome that affects about 12 million Americans, mostly women.

"This is really a sort of one-of-a-kind drug," said Dr. Bennett Roth, chief of gastroenterology at UCLA Medical Center. "It doesn't work for everybody, but in those for whom it works, it gets pretty good results. There are going to be a lot of unhappy patients."

The Food and Drug Administration said it asked for the withdrawal of Zelnorm after an analysis of 29 studies involving more than 18,000 patients found that those who took the medication had significantly higher rates of cardiac problems than those who were given a sugar pill.

Patients taking Zelnorm should call their doctors to discuss alternative treatments, the agency said. Options include laxatives. Any patients who experience chest pain, sudden weakness or other symptoms of heart attack or stroke should immediately go to the emergency room.

The drug's maker, Novartis, said it was complying with the FDA request but did not believe the drug was to blame.

A consultant who reviewed the data for the company said the rates of heart problems in patients taking Zelnorm roughly corresponded with the expected rates in the population.

But Dr. John Jenkins, head of the FDA's Office of New Drugs, said the differences between patients on Zelnorm and those given a sugar pill were significant.

Jenkins said 13 patients taking Zelnorm suffered heart attacks, chest pain or strokes, and one died. Of those taking a sugar pill, one had symptoms of a stroke that went away without further problems. None died.

Although the overall rates of problems were low 0.1% for those taking Zelnorm, compared with 0.01% for those on the sugar pill, the disparity between the two groups got the FDA's attention.

"We found the signal worrisome enough that we thought the benefit of the drug no longer outweighed the risk," Jenkins said.

Zelnorm ranked among the top 200 brand-name prescriptions last year, according to the Internet site drugtopics.com, which monitors the drug industry.

More than 2.6 million prescriptions were written for the medication in 2006, a 25% increase from the previous year.

Novartis said its sales of the drug approached $490 million in 2006. "The product was growing quickly," said spokeswoman Sherry Pudloski. It was approved in the United States in 2002.

Novartis, headquartered in Switzerland, said it would continue talking with the FDA to see whether the medication could remain available to a limited number of patients under tightly controlled conditions. The FDA followed a similar approach a few years ago with another drug for irritable bowel problems, Lotronex.

The discovery of possible heart risks followed a 2004 request from Swiss regulators for a closer look at the data. Novartis submitted the findings to the FDA beginning in February.

Swiss regulators have decided to keep Zelnorm on the market in that country with stronger warnings, Pudloski said. And Novartis is discussing the drug's future in Canada with regulators there.

Peter Lurie, deputy director of Public Citizen's Health Research Group, said his calculations indicated that those taking Zelnorm would face a seven- to eight-fold increase in risk of cardiac problems.

"When you remember that a number of patients taking this drug are younger, otherwise healthy people, the tolerance for serious side effects should be very low, even if they are rare," Lurie said.

Irritable bowel syndrome is estimated to affect up to 20% of Americans, most of whom do not seek treatment. But some patients suffer from continuing bouts of sharp abdominal pains and bloating. About a third have constipation, another third have diarrhea and the remainder alternate between the conditions.

The causes of the syndrome are not fully understood.

Novartis to stop constipation drug sale

Fri, 30 Mar 2007 00:00:00 -0700

Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was linked to a higher chance of heart attack, stroke and worsening heart chest pain that can become a heart attack, federal health officials said Friday.

Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said in a public health advisory.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said.

Doctors who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate, the FDA added.

Earlier this year, Novartis gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.

Novartis said it believes the drug provides unique benefits.

"Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients," said Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis.

The FDA first approved Zelnorm in 2002.

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

Fri, 30 Mar 2007 00:00:00 -0700

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.

FDA is currently advising patients who are using Zelnorm to contact their health care providers 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.

"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.

The analysis included more than 11,600 patients treated with Zelnorm and over 7000 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 is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks. Any such proposal would be the subject of a public advisory committee meeting before an FDA decision.

For more information, visit http://www.fda.gov/cder/drug/advisory/tegaserod.htm

FDA Finds Possible New Risks of Bowel Drug

Wed, 28 Apr 2004 00:00:00 -0700

Some users of the irritable-bowel treatment Zelnorm have suffered diarrhea so serious they require hospitalization, and four have died from an intestinal problem, the government said Wednesday.

The agency ordered that a precaution about the intestinal condition go on Zelnorm's label, along with a larger warning about severe diarrhea.

Irritable bowel syndrome is a mysterious disorder that gives millions of people, mostly women, abdominal pain and either severe diarrhea or constipation or both. Zelnorm is the only FDA-approved therapy for the constipation-causing form of the ailment. It is supposed to be used only by women.

The drug speeds the colon's movement of stools, so diarrhea is a potential side effect. But the FDA has 21 reports of diarrhea so severe that it caused such complications as low blood pressure and fainting. Sixteen patients required hospitalization, said the FDA's Dr. Robert Justice.

Zelnorm should not be used by anyone who frequently experiences diarrhea, and should be stopped immediately if patients get dizzy or faint, the FDA said.

As for the intestinal inflammation, there were no cases of ischemic colitis in studies of 7,000 Zelnorm patients. But since Zelnorm went on sale in 2002, the FDA has received 20 reports of ischemic colitis, plus three reports of a similar intestinal problem, Justice said. Fourteen patients were hospitalized. Four died, although they had numerous other serious medical conditions, he said.

The FDA advised patients who experience new or worsened abdominal pain or blood in their stools ischemic colitis symptoms to stop taking the drug and call a doctor.

Zelnorm Lawyer Injury Side Effects Attorney Cardiovascular Lawsuit Recall

Wed, 28 Apr 2004 00:00:00 -0700

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Zelnorm Side Effect Lawyers

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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 20–50% 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-LAW INFO (1-800-529-4636) for a free consultation with an experienced Zelnorm side effect lawyer.