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The U.S. Food & Drug Administration in association with The Center for Drug Evaluation and Research has released a podcast regarding the recent Zelnorm Recall.

The information contained in the podcast is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA / CDER

Run Time — 4:57 minutes

>>> CLICK HERE TO LISTEN TO ZELNORM RECALL PODCAST <<<

Full Transcript Below

[music]

On March 30, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Voluntary Market Withdrawal of Zelnorm.

The drug is also known and marketed by its generic name Tegaserod [te-gas-a-rod] maleate.

I’m Pat Clarke from F-D-A’s Center for Drug Evaluation and Research.

FDA issues this public health advisory to inform patients and health-care professionals that the sponsor of Zelnorm, Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

We announce the following four items effective immediately:

• First, at our request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
• Second, patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
• Third, patients who are taking Zelnorm should seek emergency medical care right away 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.
• Finally, physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

Zelnorm is a prescription medication approved for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years-of-age with chronic constipation.

In late February and early March 2007, Novartis Pharmaceuticals gave us the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm. These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 years and most patients — 88 percent were women.

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.

Thirteen patients treated with Zelnorm or zero point one percent, had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died) six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one or zero point zero one percent had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.

We have also indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks. However, before we make a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting.

We are asking health care professionals to report serious adverse events in connection with Zelnorm to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot gov slash MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R.

[music]

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | THE WASHINGTON TIMES

The manufacturer of the popular drug Zelnorm, used to treat constipation, pulled the product from the U.S. market yesterday at the request of federal officials who said it had been linked to an increased risk of heart attacks and strokes in rare cases.

The Food and Drug Administration released a public health advisory yesterday saying Novartis Pharmaceuticals Corp., a Swiss drug maker, had agreed to stop selling Zelnorm. Zelnorm was approved by the FDA in 2002 and accounted for $561 million in U.S. sales last year.

Zelnorm is being taken off the market because a new safety analysis found a higher chance of heart attack, stroke and worsening heart chest pain than previously thought, the FDA said.

Zelnorm is a prescription medication approved for short-term treatment of women with constipation and was approved for patients younger than 65 with chronic constipation. About 500,000 people are taking Zelnorm, with an estimated 12 million Americans suffering from symptoms related to the problem.

The FDA’s request to remove Zelnorm from the market resulted from test results Novartis submitted to the FDA earlier this year. The results showed that 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects. All patients treated in the study had a pre-existing cardiovascular disease.

FDA officials described the cardiovascular side effects as “a very rare event,” but decided to request the removal because the agency concluded the benefits of Zelnorm “no longer outweighed the risks for patients with constipation,” said Dr. John K. Jenkins, director of the FDA’s Office of New Drugs.

Novartis said it is standing behind the drug’s 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 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. And, for patients with no treatment options other than Zelnorm, the FDA said it would work with Novartis to allow access to the drug for those patients through a special program.

Zelnorm also will no longer be sold in Canada. It will remain on the market in Switzerland.

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Side Effects Lawsuit

Source | Los Angeles Times

Irritable bowel syndrome can cause constipation, which the widely prescribed drug treats. The FDA cited heart risks in requesting its withdrawal.

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 Friday.

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.

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | Public Citizen

In March 2001, Public Citizen urged the U.S. Food and Drug Administration (FDA) not to approve tegaserod (Zelnorm) because it was only marginally effective in treating constipation-predominant diarrhea in patients with irritable bowel syndrome and because of serious safety concerns. These included an increased incidence of ovarian cysts and a five-fold increase in fainting compared to placebo in patients in clinical trials completed before its approval.

Researchers at Public Citizen had also noted in the petition that receptors with which Zelnorm interacts exist not only in the intestinal tract - related to its anti-constipation effects - but also in the heart. They pointed out that cisapride, a gastrointestinal drug which also caused fainting and was taken off the market because of cardiac arrhythmias, also affected this same receptor in the heart.

Source | Harvard Medical School

This is not the first problem seen with Zelnorm since it was introduced to the U.S. market. In 2004, the FDA issued warning about Zelnorm. Some patients had developed rectal bleeding, bloody diarrhea or abdominal pain. These are symptoms of intestinal ischemia, when there is not enough blood and oxygen reaching the intestines. The connection between the drug and these symptoms was not proven, but appeared strong enough for a warning to be issued.

Full Text

Source | Associated Press

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

Novartis agreed to withdraw Zelnorm at the FDA’s request, the agency said.

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

Doctors should work with patients who take Zelnorm to help them switch to other therapies, the FDA added.

Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm as used in the treatment of a variety of gastrointestinal conditions. The analyses showed that 13 of 11,614 patients given Zelnorm experienced serious and life-threatening cardiovascular side effects, while only one of the 7,031 patients given placebos did.

FDA officials described the cardiovascular side effects as “a very rare event.” Still, “we concluded the benefits of this drug no longer outweighed the risks for patients,” said John K. Jenkins, director of the FDA’s Office of New Drugs.

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 Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs at Novartis.

The FDA first approved Zelnorm in 2002.

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | FDA

FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm.  Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

FDA announces the following, effective immediately: 

• At FDA’s request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
• Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
• Patients who are taking Zelnorm should seek emergency medical care right away 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. 
• Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.   In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels.  In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm.  These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill.  The average age of patients in these studies was 43 years and most patients—88%–were women. 

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small.  However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.  Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke.  Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects.  FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.

FDA has also indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks.  However, before FDA makes a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting. 

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | FDA 

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

####Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit